Evaluating the effectiveness and safety of a ginger supplement for chemotherapy-induced nausea and vomiting in a New Zealand population.
Supplemental Prophylactic Intervention for Chemotherapy induced nausea and Emesis (SPICE-NZ) trial of the efficacy and safety of adjuvant ginger supplementation: A New Zealand randomized controlled feasibility trial.
University of Auckland
30 participants
Apr 30, 2019
Interventional
Conditions
Summary
Chemotherapy-induced nausea and vomiting are typically treated with medications that effectively control vomiting, but provide limited, if any, relief from nausea. Two-thirds of chemotherapy patients internationally report chemotherapy-induced nausea (CIN), often rating it as the most disabling side-effect of treatment. Unpublished data from Auckland District Health Board (ADHB) oncology staff indicate CIN prevalence as high as 75%. The personal and social impacts of CIN are considerable. Research consistently demonstrates that CIN reduces patients’ quality of life and physical function, most significantly impairing their ability to undertake normal family and employment roles. CIN is further associated with increases in healthcare costs to patients and cancer services, which could be avoided with better CIN control. Critically, persistent CIN can delay cancer treatment and impair dose tolerance, culminating in poor treatment outcomes. The Australian pilot data indicate that standardised ginger supplementation could be an effective adjuvant to conventional anti-nausea therapy to address CIN. The aim of this study is to investigate the efficacy, tolerability and safety of standardised adjuvant ginger on CIN in ADHB chemotherapy patients by way of a randomised, double-blind, placebo-controlled trial. Based on Australian peer-reviewed and published protocols this project builds on their promising pilot data. It also extends an established international collaboration to a new multidisciplinary clinical and academic partnership in Auckland. If the SPICE-NZ trial demonstrates intervention effectiveness, this novel, low-cost, adjuvant for CIN could translate to clinical policy and practice, improving outcomes for patients and providing significant economic and social benefits to the health care system.
Eligibility
Inclusion Criteria4
- 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 Criteria21
- 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:
- o Prescribed medications with nausea-related side-effects, e.g. newly-prescribed opioids,
- o Diagnosed with malignancies that might cause nausea and vomiting due to the position of the cancer e.g. gastrointestinal cancer,
- o Metabolic risk factors for nausea e.g. electrolyte imbalances
- o Mechanical 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.
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Interventions
1.2g standardised non-synthetic Ginger (Zingiber officinale) extract in capsule form; over-encapsulated with a non-gelatin capsule for blinding. Frequency: 4x300mg capsules (1.2g total) per day, every 3-5 hours with food. The ginger is standardised to contain 5% gingerols (15mg active ingredient per capsule; 60mg gingerols in total). Duration: 5 days per chemotherapy cycle (Day of chemotherapy and 4 days directly after) for three 3 cycles. Initial dose is 1 hour before chemotherapy commences. All participants will be provided the supplement or placebo in identical glass bottles of 60 capsules with a single desiccant for use throughout the entire treatment period. The usual diet is unmodified, although participants will be advised to consume no fresh ginger or ginger-containing products. Strategies to monitor adherance include the collection of supplement containers with all unused supplements after T3 of the third and final chemotherapy cycle and subjects will be given a mobile phone with a pre-installed application to log events in electronic diaries.
Locations(1)
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ACTRN12619000368134