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Can ginger ameliorate chemotherapy-induced nausea? Protocol of a randomized double blind, placebo-controlled trial

Marx, Wolfgang, McCarthy, Alexandra L., Ried, Karin, Vitetta, Luis, McKavanagh, Daniel, Thomson, Damien, Sali, Avni and Isenring, Liz 2014, Can ginger ameliorate chemotherapy-induced nausea? Protocol of a randomized double blind, placebo-controlled trial, BMC complementary and alternative medicine, vol. 14, pp. 1-11, doi: 10.1186/1472-6882-14-134.

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Title Can ginger ameliorate chemotherapy-induced nausea? Protocol of a randomized double blind, placebo-controlled trial
Author(s) Marx, WolfgangORCID iD for Marx, Wolfgang orcid.org/0000-0002-8556-8230
McCarthy, Alexandra L.
Ried, Karin
Vitetta, Luis
McKavanagh, Daniel
Thomson, Damien
Sali, Avni
Isenring, Liz
Journal name BMC complementary and alternative medicine
Volume number 14
Article ID 134
Start page 1
End page 11
Total pages 11
Publisher BioMed Central
Place of publication London, Eng.
Publication date 2014-04
ISSN 1472-6882
Keyword(s) Antiemetics
Antineoplastic Agents
Clinical Protocols
Double-Blind Method
Ginger
Humans
Nausea
Neoplasms
Plant Extracts
Quality of Life
Surveys and Questionnaires
Vomiting
Science & Technology
Life Sciences & Biomedicine
Integrative & Complementary Medicine
CINV
QUALITY-OF-LIFE
PATIENTS RECEIVING TREATMENT
MEDICAL ONCOLOGY PATIENTS
ZINGIBER-OFFICINALE
EMETOGENIC CHEMOTHERAPY
MOTION SICKNESS
PHASE-II
CANCER
CISPLATIN
EFFICACY
Summary BACKGROUND: Preliminary research shows ginger may be an effective adjuvant treatment for chemotherapy-induced nausea and vomiting but significant limitations need to be addressed before recommendations for clinical practice can be made. 

METHODS/DESIGN: In a double-blinded randomised-controlled trial, chemotherapy-naïve patients will be randomly allocated to receive either 1.2 g of a standardised ginger extract or placebo per day. The study medication will be administrated as an adjuvant treatment to standard anti-emetic therapy and will be divided into four capsules per day, to be consumed approximately every 4 hours (300 mg per capsule administered q.i.d) for five days during the first three cycles of chemotherapy. Acute, delayed, and anticipatory symptoms of nausea and vomiting will be assessed over this time frame using a valid and reliable questionnaire, with nausea symptoms being the primary outcome. Quality of life, nutritional status, adverse effects, patient adherence, cancer-related fatigue, and CINV-specific prognostic factors will also be assessed. 

DISCUSSION: Previous trials in this area have noted limitations. These include the inconsistent use of standardized ginger formulations and valid questionnaires, lack of control for anticipatory nausea and prognostic factors that may influence individual CINV response, and the use of suboptimal dosing regimens. This trial is the first to address these issues by incorporating multiple unique additions to the study design including controlling for CINV-specific prognostic factors by recruiting only chemotherapy-naïve patients, implementing a dosing schedule consistent with the pharmacokinetics of oral ginger supplements, and independently analysing ginger supplements before and after recruitment to ensure potency. Our trial will also be the first to assess the effect of ginger supplementation on cancer-related fatigue and nutritional status. Chemotherapy-induced nausea and vomiting are distressing symptoms experienced by oncology patients; this trial will address the significant limitations within the current literature and in doing so, will investigate the effect of ginger supplementation as an adjuvant treatment in modulating nausea and vomiting symptoms.
Language eng
DOI 10.1186/1472-6882-14-134
Field of Research 1104 Complementary And Alternative Medicine
HERDC Research category C1 Refereed article in a scholarly journal
Copyright notice ©2014, Marx et al.
Free to Read? Yes
Use Rights Creative Commons Attribution licence
Persistent URL http://hdl.handle.net/10536/DRO/DU:30110567

Document type: Journal Article
Collections: School of Psychology
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Every reasonable effort has been made to ensure that permission has been obtained for items included in DRO. If you believe that your rights have been infringed by this repository, please contact drosupport@deakin.edu.au.