ACTRN12616000416493CompletedPhase 3
Supplemental Prophylactic Intervention for Chemotherapy induced nausea and Emesis (SPICE) trial of the efficacy, safety, and cost-effectiveness of adjuvant ginger supplementation: A multi-center randomized controlled trial
Bond University0 sites300 target enrollmentStarted: March 31, 2016Last updated:
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 300
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 18 Years to o limit (—)
- Sex
- All
Inclusion Criteria
- •Chemotherapy-naive patients (no prior history of chemotherapy).
- •Scheduled for chemotherapy classed as moderately or severely emetogenic. Moderate to highly emetogenic chemotherapy regimens informed by the Multinational Association of Supportive Care in Cancer (MASCC) and European Society of Medical Oncology (ESMO) guideline from the Perugia consensus conference
- •Scheduled for single or combined agent single-day chemotherapy regimen repeated in two, three or four-week cycles. Includes regimens with more than one type of chemotherapy agent delivered in single day doses equal to or greater than 7 days apart (e.g. as with AC-T regimens used in the treatment of breast cancer whereby cyclophosphamide and doxorubicin are administered on day one of the treatment cycle and paclitaxel is administered on days one, eight and fifteen of a 21-day cycle).
- •Aged >18 years.
- •Adequate physical function: baseline Karnofsky score > 60.
Exclusion Criteria
- •Concurrent radiotherapy.
- •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.
- •Pregnant or lactating women.
- •Concurrent use of other ginger-containing supplements and ingestion of any amount of fresh or dried ginger from 24 hours prior to chemotherapy to 7-days post chemotherapy (Cycle 1-3). Patients who plan to consume ginger during this period will be excluded from eligibility. However, once consented and commenced the intervention, participants who consume any ginger other than the study product will be included and concurrent consumption of oral ginger will be accounted for statistically. Participants will be regularly reminded to avoid consuming ginger and asked about any purposeful or incidental consumption.
- •History of adverse reactions to ginger.
- •Experiencing significant nausea and vomiting for reasons other than chemotherapy 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 (exceeding Australian Guidelines to Reduce Health Risks from Drinking Alcohol; predictive factor for decreased CIN risk).
- •Severe thrombocytopenia or likely to experience severe thrombocytopenia (platelets <50 x 10^9/L) (medical note observation).
- •Gallstones or liver disease (including liver cancer).
- •Prescribed warfarin, anti-coagulant therapy, hypoglycaemics, insulin, cyclosporine, tacrolimus, and nonsteroidal anti-inflammatory drugs.
- •Swallowing difficulties preventing supplement ingestion.
- •Self-prescribed nausea therapies or complementary products.
Investigators
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