Evaluating the effectiveness and safety of a ginger supplement for chemotherapy-induced nausea and vomiting in a New Zealand population.

Phase 4

• Conditions: Chemotherapy Induced Nausea; Chemotherapy induced Emesis; Cancer - Any cancer

• Registration Number: ACTRN12619000368134
• Lead Sponsor: niversity of Auckland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-08
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

•Chemotherapy-naive (i.e. have not yet started chemotherapy) patients scheduled for chemotherapy classed as moderately or severely emetogenic
•Aged >18 years.
•Adequate physical function: baseline Karnofsky score > 60 (patient interview).
•Females of child-bearing age entering this study must use an appropriate form of contraception. If a patient becomes pregnant during the course of this trial, they must notify the investigator as soon as possible.

Exclusion Criteria

•Patients scheduled for concurrent radiotherapy (medical note observation and/or discussion with treating oncologist).
•Non-English speaking persons
•People with severe cognitive impairment preventing their ability to fully understand the purpose of the study, adhere to the intervention and complete data collection forms. This will include diagnoses such as temporary delirium or dementia; but will be informed by the patients treating oncologist.
•Pregnant or lactating women (medical note observation and confirmed via patent interview).
•Concurrent use of other ginger-containing supplements and ingestion of large quantities of ginger (consumption of >1 ginger product > 4 days in the past week) (patient interview).
•History of adverse reactions to ginger (patient interview).
•Diagnosed with liver disease (medical note observation).
•Experiencing nausea and vomiting for reasons other than chemotherapy (medical note observation and/or discussion with treating oncologist), including:
oPrescribed medications with nausea-related side-effects, e.g. newly-prescribed opioids,
oDiagnosed with malignancies that might cause nausea and vomiting due to the position of the cancer e.g. gastrointestinal cancer,
oMetabolic risk factors for nausea e.g. electrolyte imbalances
oMechanical risk factors for nausea e.g. intestinal obstruction
•Chronic alcohol use as indicated by >14 standard drinks per week (predictive factor for decreased CIN risk)(29) (medical note observation and confirmed via patient interview).
•Severe thrombocytopenia or likely to experience severe thrombocytopenia (platelets <50 x 10^9/L) (medical note observation).
•Gallstones.
•Currently prescribed warfarin, anti-coagulant therapy, hypoglycaemics, insulin, cyclosporine, tacrolimus, and nonsteroidal anti-inflammatory drugs (hypothesised interactions) (medical note observation).
•Swallowing difficulties preventing supplement ingestion (medical note observation).
•Self-prescribed nausea therapies or complementary products (patient interview).
•Previously undergone chemotherapy treatment (medical note observation and/or discussion with treating oncologist).
•Undergoing weekly or multi-day chemotherapy regiments (medical note observation and/or discussion with treating oncologist).

Patients found to be ineligible for temporary reasons (e.g. medication prescriptions, electrolyte imbalances or recent use of ginger) will be re-screened for eligibility prior to chemotherapy commencement.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ausea-related impact on quality of life.<br>1. Instrument: Functional Living Index – Emesis – 5 Day Recall (FLIE-5DR) <br>Measure: Cronbach’s a > 0.79<br>2. . Electrogastrography (EGG) data. High-resolution EGG will be used as an objective measure of subjectively-reported patient nausea, and to correlate the onset nausea with disordered gastric electrical activity.[(1) Outcomes will be at baseline (T0); >5 days prior to chemotherapy), 1 day prior to chemotherapy (T1), on the day of chemotherapy (T2), and 4-days post-chemotherapy (T3), and 5-8 days post chemotherapy (T4 - primary timepoint) for three chemotherapy cycles<br>]