acupressure for chemotherapy-induced nausea and vomiting ... acupressure group would recommend...

Download Acupressure for chemotherapy-induced nausea and vomiting ... acupressure group would recommend P6-acupressure

If you can't read please download the document

Post on 29-May-2020

0 views

Category:

Documents

0 download

Embed Size (px)

TRANSCRIPT

  • An- Najah National University Faculty of Graduate Studies Acupressure for chemotherapy-induced nausea and vomiting in breast cancer patients: a multicenter, randomised, double-

    blind, placebo-controlled clinical trial

    By Zaida Mohamad Othman Said

    Supervisor Dr. Ayman Hussein

    Co- supervisor

    Dr. Aidah Abu ELsoud Alkaissi

    Submitted in partial Fulfillment of the Requirements for the degree of Master of public health, Faculty of Graduate Studies, at An-Najah National University,Nablus, Palestine.

    2009

  • iii

    Dedication

    Dedicated to-------

    My parents and all my familly with consistant love

  • iv

    Acknowledgment

    I would like to express my special thanks to Dr. Aidah Alkaissi and Dr. Ayman Hussein for their supervision, without their endless support this work was difficult to achieve.

    I would like to express my the thanks to the ministry of health of Palestine, and for the hospital mangers and nursing director (Al Wattani, Jenin, and Beit Jallah hospitals) for providing the facilities to conduct this study.

    I would like also to express my thanks to the oncologists (Dr. Yousef Horani, & Dr. Abed El- Rasiq Salhap for their co- operation.

    My thanks extended also to all who helped me in of the data collection of this study

    My deep appreciation goes to my parents, brothers, and sisters for their encouragements and support.

  • v

    "إقــــرار"

    : أنا الموقع أدناه مقدم الرسالة التي تحمل العنوان

    مدى تأثير أألساور الضاغطة في منع القيء والغثيان عند مريضات

    سرطان الثدي واللواتي يخضعن للعالج الكيماوي

    Acupressure for chemotherapy-induced nausea and vomiting in breast cancer patients: a multicenter, randomised, double-

    blind, placebo-controlled clinical trial ت تّم ا، باستثناء منتاج جهدي الخاّص اشتملت عليه هذه الرسالة، إنّما هو بأن ما قّرُأ

    ة درجة م من قبل لنيل أّيقّد، لم تُجزء منها أو أّي اإلشارة إليه حيثما ورد، وأن هذه الرسالة ككّل

    . ة أخرىة أو بحثّية مؤسسة تعليمّيلدى أّي و بحثّيأ أو لقب علمّي

    Declaration

    The work provided in this thesis, unless otherwise referenced, is the

    researcher’s own work, and has not been submitted elsewhere for any other

    degree or qualification.

    Student’s Name: اسم الطالب:

    Signature: عـالتوقي

    Date: خـالتاري:

  • vi

    ACRONYMS

    5HT 5 Hydroxy Tryptamine (serotonin)

    5-HT3 5-hydroxytryptamine 3

    NK1 receptor Neurokinin1-Receptor

    NV Nausea & Vomiting

    5-HIAA 5-hydroxyindoleacetic acid

    NTS Nucleus Tractus Solitarius

    CINV Chemotherapy-Induced Nausea and Vomiting

    CIV Chemotherapy Induced Vomiting

    CSF Cerebro Spinal Fluids

    QOL Quality of Life

    ANS Autonomic Nervous System

    MOH Ministry of Health

    TENS Transcutaneous Electrical Nerve Stimulator

    ASCO The American Society of Clinical Oncology

    TCM Traditional Chinese Medicine

  • vii

    List of Content Content Page Dedication iii Acknowledgment v Acronyms vi List of content ix List of tables x List of figures xi Abstract Chapter One Definition of terms 1 1 Introduction 1

    1.1 Back ground 7 1.1.1 Mechanism of chemotheray induced vomiting 7 1.1.2 Mechanism of substance P 9 1.1.3 Chemotherapy 10

    1.1.3.1 Doxorubicin 10 1.1.4 Acupuncture and acupressure 11

    1.1.4.1 Acupressure mechanism 15 1.1.4.2 Physiological aspect of acupuncture and NV 18 1.1.4.3 Stimulation 19 1.1.5 Anti emetics 19

    1.1.5.1 5 H3 receptor antagonist 20 1.1.5.2 Dexamethason 21

    Chapter Tow: Literature Review 2.1 Studies with Positive Findings 22 2.2 Studies with Negative Findings 27 2.3 Statement of the Problem 27 2.4 The Importance of the Study 28 2. 5 Hypothesis 29 2.6 Objectives 29

    2.6.1 The primary objective 29 2.6.2 The secondary objectives 30 2.7 Study Outcomes 30 Chapter Three: Methodology 3 Materials and Methods 31

    3.1 Design 33

  • viii Content Page

    3.2 Inclusion criteria 33 3.3 Exclusion criteria 33 3.4 Informed consent 33 3.5 Period of the study 33 3.6 Randomization 33 3.7 Blindness 34 3.8 Prophylactic antiemetic treatment 34 3.9 Setting 34

    3.10 Intervention 35 3.11 Measures 35 3.12 Quality of life instrument 36 3.13 Afeedback questionnaire 37 3.14 Assessment of patient satisfaction 37 3.15 Prucedures 37 3.16 Statistics and analysis 39 3.17 Ethical consideration 39 Chapter Four: Results& Analysis 4.1 Demographic data 41 4.2 Risk factors for nausea and vomiting 43 4.3 The incidence of vomiting and retching and the

    frequency of vomiting- day 1 43

    4.4 The incidence of delayed vomiting episodes day 2-5

    44

    4.5 Incidence vomiting/ retching, frequency of vomiting, incidence of acute nausea, and nausea severity: Study day 1

    45

    4.6 Incidence of delayed nausea 46 4.7 Accumulative incidence of delayed nausea 46 4.8 Delayed emetic episodes 47 4.9 Requirement of rescue anti-emetics in the

    different groups (1-5 days 48

    4.10 Analysis of patient QOL 48 4.11 Patient satisfaction 49 Chapter Five: Discussion 5.1 Methods discussion 50 5.2 Results Discussion 53

  • ix Content Page Chapter Six: Conclusion and Recommendation 6.1 Conclusion 60 6.2 Recommendation 60 References 63 Appedix

    Appendix A

    Functional Assessment of Cancer Therapy-G (FACT-G)

    82

    Appendix B

    functional assessment of chronic illness therapy (DACT) licensing agreement

    84

    Appendix C

    Patient self assessment tool(Questionnaire) 86

    ب الملخص

  • x

    List of Tables

    Table No Content Page Table4.1. Demographic characteristics of patients in

    treatment groups 41

    Table 4.2. Risk factors for nausea and vomiting were divided into treatment groups

    42

    Table 4.3. Incidence & severity of nausea, vomiting/retching of patients in the treatment groups during first 24 h following chemotherapy

    42

    Table 4.4. Incidence of delayed vomiting episodes: Days 2-5, n (%) in the three groups after chemotherapy

    44

    Table 4. 5. Severity of delayed nausea Days 2-5 in the three groups. Values given as Mean (SD)

    45

    Table 4.6. Incidence of delayed nausea Days 2-5 in the three groups, values given in a dichotomous fashion (yes or no)

    46

    Table 4.7. Accumulative incidence of delayed nausea Days 2-5 ≥ 3 (0-6 scale) of moderate to very severe nature in the three groups

    46

    Table 4.8. Number of delayed emetic episodes Days 2-5 in the three groups. Values given as Mean (SD

    47

    Table 4.9. Requirement of rescue anti-emetics in the three group’s days 1-5

    48

    Table 4.10. Comparison of the study outcomes by Analyses of QOL by using FACT-G

    48

    Table 4.11. Overall patients´ satisfaction with acupressure and if they would recommend other patients to wear bands when receiving chemotherapy

    49

  • xi

    List of Figers

    Figer No Content Page Figure 1. The locationof pericardiumP6 point(Neigumn)and

    position of acupressure Band in both Active (acupressure) and a non acopoint (placebo) groups. Alkaissi et al 2002

    32

  • xii Acupressure for chemotherapy-induced nausea and vomiting in breast cancer patients: a multicenter, randomised, double-

    blind, placebo-controlled clinical trial By

    Zaida Mohamad Othman Said Supervisor

    Dr. Ayman Hussein Co- supervisor

    Dr. Aidah Abu Elsoud Alkaissi

    Abstract

    Purpose: To examine the efficacy of P6-acupressure in preventing

    chemotherapy- induced nausea and emesis associated with highly

    emetogenic chemotherapy (i.e. doxorubicin as adjuncts to standard 5-HT3

    receptor antagonist (granisetron) and dexamethasone as antiemetic given as

    part of routine care in reducing acute nausea (during the day of treatment)

    and delayed nausea (2-5 days) following the day of chemotherapy. The

    second aim is to examine the efficacy of the acupressure bands with

    stimulation of P6 in reducing vomiting and in maintaining Quality of Life

    (QOL).

    Patients and methods: A randomized, double-blind, placebo controlled

    trial. One group received acupressure with bilateral stimulation of P6

    (n=42), a second group received bilateral placebo stimulation, (n=42) and a

    third group received no acupressure wrist band and served as a control

    group, (n=42). Acupressure was applied using a Sea-Band (Sea- Band UK

    Ltd., Leicestershire,