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What are the Effects of Ginger on Chemotherapy Induced Nausea/Vomiting in Breast Cancer Patients ? Minna Sabbahi College of Saint Elizabeth Dietetic Internship 2014-2015

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Page 1: Evidence Analysis Case Study

What are the Effects of Ginger on Chemotherapy Induced Nausea/Vomiting in Breast Cancer Patients ?Minna Sabbahi

College of Saint Elizabeth

Dietetic Internship 2014-2015

Page 2: Evidence Analysis Case Study

Overview Breast Cancer

Breast Cancer Overview Treatment: Chemotherapy

Homeopathic/Alternative Medicine Ginger

Introduction to the Patient ADIME

Evidence Analysis Question PICO

Inclusion/Exclusion Criteria Research Review Included Articles Excluded Articles

Conclusion Statement/Grade

Page 3: Evidence Analysis Case Study

Breast Cancer: Physiology

Lobules (milk-producing glands

that are stimulated by estrogen and progesterone)

Ducts (tiny tubes that carry the milk from the lobules to the

nipple)

Stroma (fatty tissue and connective tissue

surrounding the ducts, lobules, blood

vessels, and lymphatic vessels)

Page 4: Evidence Analysis Case Study

Breast Cancer: Occurrence

Cancer that forms in the tissues of the breast, usually the ducts and lobules.

Benign vs. Malignant Tumors Benign Tumor- Not cancerous Malignant Tumor- a group of cancer cells that can grow into (invade)

surrounding tissues or spread (metastasize) to distant areas of the body

Metastasis- the process in which cancerous cells travel to other parts of the body where they begin to grow and form new tumors that replace normal tissue Happens when the cancer cells get into the bloodstream or lymph vessels Most Common: Brain, Lungs, Liver, Bones

Page 5: Evidence Analysis Case Study

Breast Cancers: Types

Ductal Carcinoma in situ (DCIS; intraductal carcinoma) Non-invasive or pre-invasive Cells have not spread through the walls of the ducts into the surrounding tissue breast Cannot spread/metastasize

Invasive Ductal Carcinoma Most common type of breast cancer Milk Duct Breaks through wall of duct Grown into the fatty tissue of the breast May be able to spread/metastasize

Less Common Types: Inflammatory Breast CA Paget disease of the nipple Phyllodes tumor Angiosarcoma

Page 6: Evidence Analysis Case Study

Breast Cancer: Classifying Subtypes

Hormone Receptors

Positive: the breast CA cells contain either estrogen or progesterone receptors. Tx: Hormone Therapy.

Negative: the breast CA cells don’t have either estrogen or progesterone. Hormone therapy not effective.

HER2/neuPositive: CA that have too much HER2 protein. Tx:

drugs that target HER2.

Negative: CA that don’t have excess HER2. Do not respond to tx with drugs that target HER2.

TriplePositive: ER+, PR+, excess HER2. TX: hormone therapy

and drugs.

Negative: ER-, PR-,no excess HER2. Tend to grow and spread more quickly than other types. Tx: Chemotherapy.

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Breast Cancer: Staging

Stage can be based either on the results of physical exam, biopsy, and imaging tests (called the clinical stage), or on the results of these tests plus the results of surgery (called the pathological stage)

The American Joint Committee on Cancer: TNM Staging System T 0, 1, 2, 3, 4refers to tumor size and spread to the skin or to the chest

wall under the breast N 0, 1, 2, 3indicated whether the cancer has spread to the lymph nodes

near the breast and, if so, how many lymph nodes are affected M 0,1indicates whether the cancer has spread to distant organs

(metastasis)

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Breast Cancer: Staging Stages MeaningStage 0: Tis=T0, N0, M0 Ductal carcinoma in situ (DCIS), a pre-cancer of the

breast. Cancer cells are still within a duct and have not invaded deeper into the surrounding fatty tissue breast

Stage IA: T1, N0, M0 The tumor is 2cm or less and has no spread to the lymph nodes or distant sites

Stage II: (Stage A and B) T0-T3, N0-N1, M0

*Variations in T and N, M always 0*The tumor is between 2cm and 5 cm and has spread to 1-3 axillary lymph nodes, but not spread to distant sites

Stage III: (Stage A, B, and C) T0-T4, N0-N3, M0

*Variations in T and N, M always 0*The tumor can be between 2cm and any size and has spread to up to 10 or more axillary nodes, but not spread to distant sites

Stage 4: any T, any N, M1 The cancer can be any size and may or may not have spread to nearby lymph nodes. It has spread to distant organs (commonly: bone, liver, brain, or lung)

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Breast Cancer: Staging

Page 10: Evidence Analysis Case Study

Breast Cancer: Staging

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Breast Cancer: Signs and Symptoms

Breast lump or thickening that feels different from the surrounding tissue

Bloody discharge from the nipple

Change in the size or shape of the breast

Change in the skin over the breast, such as dimpling

Inverted nipple

Peeling, scaling or flaking of the nipple or breast skin

Redness or pitting of the skin over the breast

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Breast Cancer: Signs and Symptoms

Page 13: Evidence Analysis Case Study

Breast Cancer: Risk Factor Gender: Breast CA is about 100 x more common among women than men

Aging: As you get older, risk for developing Breast CA increases

Race/Ethnicity: White women are more likely to develop breast cancer than African-American women, but African-American more likely to die of this cancer. However, in women under 45 years of age, breast CA is more common in African-American women.

Inherited Genes: Most common cause of hereditary breast CA is an inherited mutation in the BRCA1 and BRCA 2 genes (in normal cells, these genes help prevent CA by making proteins that keep the cells from growing abnormally)

Presence of HER2/neu-growth promoting protein

Previous chest radiation

Dense Breast Tissue

Family history: Breast CA risk is higher among women whose close blood relatives have this disease Having a first-degree relative (mother, sister, or daughter) doubles a woman’s risk Having a second-degree relative increases risk about 3-fold

Page 14: Evidence Analysis Case Study

Breast Cancer: Statistics

Second leading cause of cancer death in women, exceeded only by Lung CA

About 1 in 8 women in the US (12%) will develop invasive breast CA over the course of her lifetime

Currently, more than 2.8 million Breast CA survivors in the U.S. (includes women being treated and those who have completed treatment)

The American Cancer Society’s estimates for breast cancer in the U.S. for 2015: About 231, 840 new cases of invasive breast cancer will be diagnosed in women About 60,290 new cases of carcinoma in situ will be diagnosed (a non-invasive,

earliest form of breast CA) About 40, 290 women will die from breast cancer

Page 15: Evidence Analysis Case Study

Types of Treatment

• Treatment with cancer-killing drugs that may be given intravenously or by mouth. Drugs travel through the bloodstream to reach the cancer cells

Chemotherapy

• Treatment with high-energy rays or particles that destroy cancer cells

• Can be given externally (external beam radiation) or internally (brachytherapy)

Radiation

• Needed to remove a breast tumor (Lumpectomy/partial mastectomy)

• Options: Breast-conserving and mastectomy Surgery

• Systemic therapy• Administration of drugs that block estrogen/lower

estrogen levels

Hormone Therapy

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Treatment: Chemotherapy What is it?

Tx with cancer-killing drugs that may be given intravenously or by mouth. The drugs travel through the bloodstream to reach cancer cells in most parts of the body.

When is it used? Given in cycles, with each period of tx followed by a recovery period Adjuvant Chemo (After surgery) Neoadjuvant Chemo (Before surgery) Main treatment

Types Common: Docetaxel, Paclitaxel, Platinum agents, Vinorelbine, Capecitabine, Liposomal

doxorubicin, Gemcitabine, Mitoxantrone, Ixabepilone, Albumin-bound paclitaxel, Eribulin Most effective when combinations of more than one drug are used

Most common Anthracyclines, taxanes, used in combinations with fluorouracil,

cyclophosphamide, and carboplatin

Page 17: Evidence Analysis Case Study

Chemotherapy: Nutritional Implications

Possible Side Effects: Hair loss and nail changes Mucositis: Mouth sores Loss of appetite or increased appetite Nausea and vomiting** (CINV)

Anticipatory-occurs before the start of chemo and develops in 8-20% of patients

Acute-occurs within 24 hours post-chemo Delayed-occurs after 24 hours and up to 5 days post-chemo

Diarrhea and Constipation Taste Changes Smell Changes Fatigue

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Breast Cancer: MNT

MNT

Calories: 30-35

kcal/kg

Protein: 1.0-1.5 gm/kg

Fluid: 1mL/Kcal

Goals: • Adequate macro and

micronutrient intake

• Weight maintenance/minimize weight loss

• Minimize treatment toxicities:

• Nausea• Vomiting• Diarrhea• Constipation• Mucositis• Esophagitis• Dysphagia• Odynophagia

Page 19: Evidence Analysis Case Study

Ginger (Zingiber Officinale)

Underground rhizome (root) of the ginger plant

Today, the top commercial producers of ginger include Jamaica, India, Fiji, Indonesia, and Australia

Most notably known for its role as a flavoring agent for food in Asian and Indian Cuisine

Listed as a food on the FDA’s “generally regarded as safe” list (<4 gm/daily)

Health Benefits: GI Relief Anti-Inflammatory Effects Anti-emetic properties

Pregnancy Chemotherapy

Page 20: Evidence Analysis Case Study

Ginger: Bioactive Components and Mechanism of Action

In herbal medicine: carminative and spasmolytic

Gingerols are the major constituents of fresh ginger

Has at least 14 bioactive compounds

The oleoresin from the rhizomes of ginger contains [6]-gingerol primary ingredient believed to exert a variety of

pharmacological and physiological activities

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Introduction to PatientADIME: Assessment

Client History: CBJ is 51 year old female admitted for severe pain and N/V secondary to chemotherapy treatment for Stage IV Breast Cancer. Throughout her stay at the hospital, biopsy report indicated that metastatic Breast cancer w/ persistent n/v, abdominal carcinomatosis, and bone mets.

Pmhx: Stage IV Breast Cancer s/p Chemotherapy s/p Radiation

Food/Nutrition History: Patient reports eating a regular diet at home. Pt. on opiods for pain management and antiemetic therapy for N/V and takes Boost + at home. Has been experiencing poor appetite prior to admission x 5 days.

Anthropometrics: Height: 165.10 cm—65 in Weight: 73.5 kg—162 kg IBW (+10%): 62 kg—136 kg IBW %: 119% BMI: 27

Current Diet Order: Full Liquids Diet. Pt. receiving supplementation: Boost + (360 kcal, 14 g pro), Boost Breeze (250 kcal, 9 g pro), and Isopure (60 kcal, 15 g pro).

Page 22: Evidence Analysis Case Study

ADIME: Assessment Biochemical Data:

Medications: Senokot (laxative), Ativan (anxiety), Lovenox (DVT, blood thinner), MOM (milk of magnesia, opiod), Metformin (Type II DM), Fentanyl (synthetic opiate), Dialudid (Narcotic Pain Reliever), Zofran (antiemetic), Oxycodone (opiod)

Nutritional Risk: High Risk

Lab Value High/LowSodium 148 WNL

Potassium 3.4 Low

BUN 7 WNL

Creatinine 0.9 WNL

Blood Sugar 112 High

Albumin 3.6 WNL

WBC 6.45 WNL

RBC 4.11 WNL

Page 23: Evidence Analysis Case Study

ADIME: Diagnosis

Inadequate Energy Intake related to poor appetite secondary to persistent N/V related to chemotherapy treatment for Stage IV Breast Cancer as evidenced by consistent emesis and intake of <25% of meals

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ADIME: Intervention

Nutrition Prescription: Estimated Needs

30 kcal/kg—1860 kcal/day 1.2-1.4 gm/kg—74-87 grams protein/day 30 ml/kg—2208 mL fluid/day

Continue to provide Supplementation Boost + (360 kcal, 14 g pro) Boost Breeze (250 kcal, 9 g pro) Isopure (60 kcal, 15 g pro)

Encourage Intake of Supplementation

Reinforce with patient importance of weight maintenance and proper intake

Page 25: Evidence Analysis Case Study

ADIME: Monitoring/Evaluation

PO intake Patient will consume approximately 25-50% of meals and will tolerate supplementation; Follow- up with RN ADL and food records, speak with patient during follow-up visit regarding intake and tolerance of supplementation

Weight Maintenance Patient will maintain weight; RN weekly bedside weights

Knowledge Patient will understand the importance of adequate energy intake while undergoing chemotherapy treatment; Patient will verbalize benefit of small frequent meals and/or supplementation

Page 26: Evidence Analysis Case Study

What are the Effects of Ginger on Chemotherapy Induced Nausea/Vomiting (CINV) in Breast Cancer Patients ?

Page 27: Evidence Analysis Case Study

P: Population

• Patients with breast cancer and undergoing chemotherapy

I: Intervention

• Patients receiving Ginger for CIN/V

C: Comparison

• Patients who do not take Ginger for CIN/V

O: Outcomes

• Lowering the side effects of Chemotherapy Induced N/V

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Inclusion/Exclusion Criteria Criteria Inclusion Exclusion

Age >18 years old <18 years old

Species Human Nonhumans

Sex Women Men

Diagnosis Breast Cancer All other types of Cancer

Intervention Administration of Ginger Antiemetics/Other types of homeopathic medications

Study Design Original, Randomized, Clinical-controlled

Review, Meta-analysis

Journal Type Peer-reviewed Non Peer-reviewed

Year of Publication 2003-present Prior to 2003

Page 29: Evidence Analysis Case Study

Research Review

Search Terms: Ginger, Chemotherapy induced Nausea/Vomiting, Breast Cancer

Results: PubMed: 80 EBSCO: 15 Google Scholar: 4,600

Articles: Total: 10 Articles Included: 4 Articles Excluded: 6

Page 30: Evidence Analysis Case Study

Included Articles

1. Panahi, Y., Saadat, A., Sahebkar, A., Hashemian, F., Taghikhani, M., & Abolhasani, E. (2012). Effect of ginger on acute and delayed chemotherapy-induced nausea and vomiting: a pilot, randomized, open-label clinical trial. Integrative cancer therapies, 1534735411433201.

2. Ebrahimi, S. M., Parsa-Yekta, Z., Nikbakht-Nasrabadi, A., Hosseini, S. M., Sedighi, S., & Salehi-Surmaghi, M. (2013). Ginger effects on control of chemotherapy induced nausea and vomiting. (english). Tehran University Medical Journal, 71(6), 395-403.

3. Ryan, J. L., Heckler, C. E., Roscoe, J. A., Dakhil, S. R., Kirshner, J., Flynn, P. J., … Morrow, G. R. (2012). Ginger (Zingiber officinale) reduces acute chemotherapy-induced nausea: A URCC CCOP study of 576 patients. Supportive Care in Cancer, 20(7), 1479–1489. doi:10.1007/s00520-011-1236-3

4. Aapro, M., Molassiotis, A., Dicato, M., Peláez, I., Rodríguez-Lescure, Á., Pastorelli, D., ... & Roila, F. (2012). The effect of guideline-consistent antiemetic therapy on chemotherapy-induced nausea and vomiting (CINV): the Pan European Emesis Registry (PEER). Annals of oncology, mds021.

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Included Article

Purpose/Study Type To evaluate the effects of ginger against both acute and delayed form of CINV in a population with advanced breast cancer as the main malignancy

Population 100 women (mean age 51.83 ± 9.18 years) with advanced breast cancer

Intervention Pilot, randomized, open-label clinical trial. 100 women with advanced breast cancer who were initially assigned to standard chemotherapy protocol with docetaxel, epirubicin, and cyclophosphadime (TEC regimen) were randomized to receive ginger (1.5 g/d in 3 doses divided every 8 hours) plus antiemetic regimen (granisteron plus dexmethasone; the ginger group) or standard antiemetic regimen alone (the control group). The duration of the treatment was specified to 4 days from the initiation of chemo. Prevalence, score, and severity of nausea, vomiting, and retching were assessed using a simplified form of Rhodes Index in the first 6 hours, between 6 to 24 hours, and days 2, 3, and 4 post chemo.

Outcome A significantly lower prevalence of nausea was observed in the ginger group during 6 to 24 hours post chemotherapy. Despite this effect, no other significant additional benefit from ginger (1.5 g/d) was observed against prevelance of severity of nausea, vomiting, and retching in any of the assessed periods.

Conclusion Addition of ginger (1.5 g/d) to standard antiemetic therapy (granisetron plus dexamethasone) in patients with advanced breast cancer effectively reduced the prevalence of nausea 6 to 24 hours post chemotherapy. However, there is no additional advantage for ginger in reducing prevalence or severity of acute or delayed CINV.

Panahi, Y., Saadat, A., Sahebkar, A., Hashemian, F., Taghikhani, M., & Abolhasani, E. (2012). Effect of ginger on acute and delayed chemotherapy-induced nausea and vomiting: a pilot, randomized, open-label clinical trial. Integrative cancer therapies, 1534735411433201. Class A Rating +

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Included Article

Purpose/Study Type To investigate the effect of ginger capsules on the alleviation of CIN in the anticipatory and acute phase of cancer therapy

Population 80 women with breast cancer between August till December 2009 in Imam Khomeini Hospital in Tehran, Iran

Intervention Randomized, double-blind, placebo-controlled clinical trial. Samples were randomly assigned to patients who underwent one-day chemotherapy regimen. The intervention group received ginger capsules (250 mg, orally) four times a day (1 gr/d) while the placebo group received starch capsules (250 mg, orally), both for three days before to three days after chemotherapy. To measure the effect of the capsules, a three-part questionnaire was answered by the patients nightly. Gathered data were analyzed by statistical tests like Fisher’s exact, Kruskal-Wallis, and Chi-square using version 8 of STATA software.

Outcome The mean ± SD age in the intervention and placebo groups were 41.8 ±8.4 and 45.1±10 years, respectively. Results indicated that the severity and number of nausea in the anticipatory phase were significantly lower in the ginger group compared with the placebo group. Also, the intensity and number of nausea in the acute phase were significantly lower in the ginger group. On the other hand, taking ginger capsules compared with placebo did not result in any major complications.

Conclusion Consuming ginger root powder capsules (1gr/d) from three days before chemotherapy till three days after it in combination with the standard anti-emetic regimen can help to reduce the anticipatory and acute nausea.

Ebrahimi, S. M., Parsa-Yekta, Z., Nikbakht-Nasrabadi, A., Hosseini, S. M., Sedighi, S., & Salehi-Surmaghi, M. (2013). Ginger effects on control of chemotherapy induced nausea and vomiting. (english). Tehran University Medical Journal, 71(6), 395-403. Class A Rating+

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Included Article

Purpose/Study Type To determine the effect of ginger on CINV in cancer patients.

Population 576 adult cancer patients., mean age: 53 years. 93% women. 72% breast, 28% alimentary genitourinary, gynecologic, hematologic, lung.

Intervention Randomized, double-blind, placebo-controlled, dose-finding trial. Patients took three capsules of ginger (250 mg) [0.5 g, 1.0 g, or 1.5 g] or placebo twice daily for six days starting three days before the first day of chemotherapy. All patients received a 5-HT3 receptor antagonist antiemetic on Day 1 of all cycles Patients reported the severity of nausea on a 7-point rating scale (“1” = “Not at all Nauseated” and “7” = “Extremely Nauseated”) for Days 1-4 of each cycle.

Outcome A total of 576 patients were included in final analysis (91% female, mean age = 53). Mixed model analyses demonstrated that all doses of ginger significantly reduced acute nausea severity compared to placebo on Day 1 of chemotherapy (p = 0.003). The largest reduction in nausea intensity occurred with 0.5 g and 1.0 g of ginger (p = 0.017 and p = 0.036, respectively). Anticipatory nausea was a key factor in acute chemotherapy-induced nausea (p < 0.0001).

Conclusion Ginger supplementation at a daily dose of 0.5 g–1.0 g significantly aids in reduction of the severity of acute chemotherapy-induced nausea in adult cancer patients.

Ryan, J. L., Heckler, C. E., Roscoe, J. A., Dakhil, S. R., Kirshner, J., Flynn, P. J., … Morrow, G. R. (2012). Ginger (Zingiber officinale) reduces acute chemotherapy-induced nausea: A URCC CCOP study of 576 patients. Supportive Care in Cancer, 20(7), 1479–1489. doi:10.1007/s00520-011-1236-3 Class A Rating +

Page 34: Evidence Analysis Case Study

Included Article

Purpose/Study Type To evaluate the effect of guideline-consistent CINV prophylaxis (GCCP) on chemotherapy patient outcomes of CINV.

Population 991 chemotherapy-naive adults, both males and females >!8 years, initiating single-day highly or moderately emetogenic chemotherapy (HEC or MEC) for cancer. Almost three quarters of patients were women, with a significantly greater proportion of women in the GCCP (guideline-consistent CINV prophylaxis) cohort, and 99% of patients were white. Breast cancer was the most common diagnosis.

Intervention Prospective, observational multicenter study enrolled. Patients completed 6-day daily diaries beginning with cycle 1 for up to three chemotherapy cycles. Patients completed the daily diary beginning before chemotherapy (on day 1) and for a total of six calendar days. Before chemotherapy administration, patients recorded whether they had any emesis in the prior 24 h and, on three separate visual analogue scales (VAS, scored from 0, none, to 100, maximum), whether they had any nausea or anxiety in the prior 24 h or any expectation of nausea. Patients recorded the time and date of emetic episodes, the severity of nausea and of anxiety (0–100 VAS), and use of rescue medication (type and dosage). On day 6 of cycle 1, patients recorded use of complementary therapies (such as acupressure, herbal remedies, yoga, and relaxation techniques) and health care visits to manage nausea or vomiting in the prior 5 days. Completion of the cycle 1 diary was required for patients to continue in the study to cycle 2, and completion of the cycle 2 diary, to continue to cycle 3. Secondary antiemetic therapies were prescribed to 29% of patients overall with no significant difference between GCCP and GICP cohorts

Outcome The percentage of patients with complete response (no emesis or rescue therapy) was significantly higher in the GCCP cohort than in the GICP (guideline-inconsistent CINV prophylaxis) cohort during both acute and delayed phases as well as overall (during 120 h post-chemotherapy.

Conclusion Our study results indicate that there is a significant benefit of guideline-consistent antiemetic therapy across a range of CINV end points in the acute and delayed phases and overall.

Aapro, M., Molassiotis, A., Dicato, M., Peláez, I., Rodríguez-Lescure, Á., Pastorelli, D., ... & Roila, F. (2012). The effect of guideline-consistent antiemetic therapy on chemotherapy-induced nausea and vomiting (CINV): the Pan European Emesis Registry (PEER). Annals of oncology, mds021. Class C Rating -

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Excluded Articles Article Results Reason for Exclusion

Alparslan, G. B., Ozkarman, A., Eskin, N., Yilmaz, S., Akay, M., Acikgoz, A., & Orsal,O. (2012). Effect of ginger on chemotherapy-induced nausea and/or vomiting in cancer patients. Journal of the Australian Traditional-Medicine Society, 18(1), 15-18.

Class ARating +

The study group was composed of intervention (n=15) and control (n=30) patients receiving chemotherapeutic agents in a hematology clinic in Australia. Control patients received antiemetic drugs and intervention patients received ginger tablet (800 mg). Analysis revealed a significant difference between the groups, suggesting that ginger is effective for treatment of nausea and vomiting.

Population not limited to just Breast Cancer Patients. Patients included all had a form of hematological cancer.

Zick, S. M., Ruffin, M. T., Lee, J., Normolle, D. P., Siden, R., Alrawi, S., & Brenner, D. E. (2009). Phase II trial of encapsulated ginger as a treatment for chemotherapy-induced nausea and vomiting. Supportive care in cancer, 17(5), 563-572.Class ARating +

A randomized double-blind, placebo-controlled trail in 162 patients with cancer who were receiving chemotherapy. Participants received either 1.0 g ginger, 2.0 g ginger daily, or matching placebo for 3 days. The conclusion found that ginger provides no additional benefit for reduction of the prevalence or severity of acute or delayed CINV when given with 5-HT3 receptor antagonists and/or aprepitant.

Population not limited to just Breast Cancer Patients.

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Excluded Articles Article Results Reason for Exclusion

Levine, M. E., Gillis, M. G., Koch, S. Y., Voss, A. C., Stern, R. M., & Koch, K. L. (2008). Protein and ginger for the treatment of chemotherapy-induced delayed nausea. Journal of Alternative & Complementary Medicine, 14(5), 545-551. doi:10.1089/acm.2007.0817

Class ARating +

28 patients with cancer receiving chemotherapy for the first time were assigned to 1 of 3 groups. For 3 days beginning the day after their chemotherapy, Control Group patients continued with their normal diet, Protein Group patients consumed a protein drink and ginger twice daily, and High Protein Group patients consumed a protein drink with additional protein and ginger twice daily. Conclusions: High protein meals with ginger reduced the delayed nausea of chemotherapy and reduced use of antiemetic medications. Protein with ginger holds the potential of representing a novel, nutritionally based treatment for the delayed nausea of chemotherapy.

Population not limited to just Breast Cancer Patients

Intervention focused on two aspects, of which protein being the primary aspect

Dupuis, M. L. L., & Nathan, P. C. (2003). Options for the prevention and management of acute chemotherapy-induced nausea and vomiting in children. Pediatric Drugs, 5(9), 597-613.

Class ARating +

Complementary intervention with ginger has also been suggested to have possible benefits in preventing acute chemotherapy-induced nausea and vomiting (CINV) in children.

Population Age < 18 years old

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Excluded Articles Article Results Reason for Exclusion

Qian Q. H, Yue W, Wang Y. X, Yang Z. H, Liu Z. T, Chen W. H. Gingerol inhibits cisplatin- induced vomiting by down regulating 5-hydroxytryptamine, dopamine and substance P expression in minks. Arch Pharm Res. 2009;32(4):565–73. [PubMed]Class ARating +

Gingerol was reported to reduce cisplatin (a platinum-based chemotherapy drug)-induced emesis in a vomiting model of mink possibly by inhibiting the central or peripheral increase of 5-hydroxytryptamine, dopamine, and substance P.

Species is Non-Human

Manusirivithaya, S., Sripramote, M., Tangjitgamol, S., Sheanakul, C., Leelahakorn, S., Thavaramara, T., & Tangcharoenpanich, K. (2004). Antiemetic effect of ginger in gynecologic oncology patients receiving cisplatin. International Journal of Gynecological Cancer, 14(6), 1063-1069.

Class ARating +

Subjects were randomly allocated to regimen A or regimen B in their first cycle of the study. All patients received standard antiemetics in the first day of cisplatin administration. In regimen A, capsules of ginger root powder were given orally 1 g /day for 5 days, starting on the first day of chemotherapy. In regimen B, placebo was given on the first day and metoclopramide was given orally thereafter for 4 days. The patients were then crossed over to receive the other antiemetic regimen in their next cycle of chemotherapy. In conclusion, addition of ginger to standard antiemetic regimen has no advantage in reducing nausea or vomiting in acute phase of cisplatin-induced emesis. In delayed phase, ginger and metoclopramide have no statistically significant difference in efficacy.

Population not limited to just Breast Cancer Patients

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Conclusion Statement and Grade

What are the Effects of Ginger on Chemotherapy Induced Nausea/Vomiting in Breast Cancer Patients ?

Overall, there is an agreement that ginger is a promising antiemetic herbal remedy, but the clinical data are insufficient to draw firm conclusions. While there have been several studies that found that support the use of ginger for chemotherapy induced nausea and vomiting, other studies have found no evidence to support this hypothesis. Research on this topic has been limited, particularly with breast cancer patients, and further studies are required in order to determine the impacts of ginger on CINV in breast cancer.

GRADE III: LIMITED/WEAK

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References American Cancer Society. “Breast Cancer” Available from:

http://www.cancer.org/acs/groups/cid/documents/webcontent/003090-pdf.pdf. Accessed on March 3, 2015.

Bode AM, Dong Z. The Amazing and Mighty Ginger. In: Benzie IFF, Wachtel-Galor S, editors. Herbal Medicine: Biomolecular and Clinical Aspects. 2nd edition. Boca Raton (FL): CRC Press; 2011. Chapter 7. Available from: http://www.ncbi.nlm.nih.gov/books/NBK92775/

Alparslan, G. B., Ozkarman, A., Eskin, N., Yilmaz, S., Akay, M., Acikgoz, A., & Orsal, O. (2012). Effect of ginger on chemotherapy-induced nausea and/or vomiting in cancer patients. Journal of the Australian Traditional-Medicine Society, 18(1), 15-18.

Ebrahimi, S. M., Parsa-Yekta, Z., Nikbakht-Nasrabadi, A., Hosseini, S. M., Sedighi, S., & Salehi-Surmaghi, M. (2013). Ginger effects on control of chemotherapy induced nausea and vomiting. (english). Tehran University Medical Journal, 71(6), 395-403.

Panahi, Y., Saadat, A., Sahebkar, A., Hashemian, F., Taghikhani, M., & Abolhasani, E. (2012). Effect of ginger on acute and delayed chemotherapy-induced nausea and vomiting: a pilot, randomized, open-label clinical trial. Integrative cancer therapies, 1534735411433201.

Ryan, J. L., Heckler, C. E., Roscoe, J. A., Dakhil, S. R., Kirshner, J., Flynn, P. J., … Morrow, G. R. (2012). Ginger (Zingiber officinale) reduces acute chemotherapy-induced nausea: A URCC CCOP study of 576 patients. Supportive Care in Cancer, 20(7), 1479–1489. doi:10.1007/s00520-011-1236-3

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References Panahi, Y., Saadat, A., Sahebkar, A., Hashemian, F., Taghikhani, M., & Abolhasani, E. (2012). Effect of ginger on acute and

delayed chemotherapy-induced nausea and vomiting: a pilot, randomized, open-label clinical trial. Integrative cancer therapies, 1534735411433201.

Ryan, J. L., Heckler, C. E., Roscoe, J. A., Dakhil, S. R., Kirshner, J., Flynn, P. J., … Morrow, G. R. (2012). Ginger (Zingiber officinale) reduces acute chemotherapy-induced nausea: A URCC CCOP study of 576 patients. Supportive Care in Cancer, 20(7), 1479–1489. doi:10.1007/s00520-011-1236-3

Qian Q. H, Yue W, Wang Y. X, Yang Z. H, Liu Z. T, Chen W. H. Gingerol inhibits cisplatin- induced vomiting by down regulating 5-hydroxytryptamine, dopamine and substance P expression in minks. Arch Pharm Res. 2009;32(4):565–73. [PubMed]

Levine, M. E., Gillis, M. G., Koch, S. Y., Voss, A. C., Stern, R. M., & Koch, K. L. (2008). Protein and ginger for the treatment of chemotherapy-induced delayed nausea. Journal of Alternative & Complementary Medicine, 14(5), 545-551. doi:10.1089/acm.2007.0817

Qian Q. H, Yue W, Wang Y. X, Yang Z. H, Liu Z. T, Chen W. H. Gingerol inhibits cisplatin- induced vomiting by down regulating 5-hydroxytryptamine, dopamine and substance P expression in minks. Arch Pharm Res. 2009;32(4):565–73. [PubMed]

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induced nausea and vomiting in children. Pediatric Drugs, 5(9), 597-613.

Zick, S. M., Ruffin, M. T., Lee, J., Normolle, D. P., Siden, R., Alrawi, S., & Brenner, D. E. (2009). Phase II trial of encapsulated ginger as a treatment for chemotherapy-induced nausea and vomiting. Supportive care in cancer, 17(5), 563-572.

Aapro, M., Molassiotis, A., Dicato, M., Peláez, I., Rodríguez-Lescure, Á., Pastorelli, D., ... & Roila, F. (2012). The effect of guideline-consistent antiemetic therapy on chemotherapy-induced nausea and vomiting (CINV): the Pan European Emesis Registry (PEER). Annals of oncology, mds021.

Manusirivithaya, S., Sripramote, M., Tangjitgamol, S., Sheanakul, C., Leelahakorn, S., Thavaramara, T., & Tangcharoenpanich, K. (2004). Antiemetic effect of ginger in gynecologic oncology patients receiving cisplatin. International Journal of Gynecological Cancer, 14(6), 1063-1069.

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