CompletedPhase 3ACTRN12616000416493

Evaluating the efficacy, safety, and cost-effectiveness of adjuvant ginger supplementation for chemotherapy-induced nausea and vomiting

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

Sponsor

Bond University

Enrollment

300 participants

Start Date

Jul 3, 2018

Study Type

Interventional

Conditions

Chemotherapy-induced nausea Chemotherapy-induced vomiting Treatment-related fatigue Malnutrition

Summary

What the is aim of this study? The primary purpose of this trial is to evaluate the efficacy and cost-effectiveness of ginger supplementation for the treatment of chemotherapy-induced nausea and vomiting. Who is it for? You may be eligible to participate in this trial if you are aged 18 years or older, and are scheduled to begin your first regimen of chemotherapy using an agent classed as moderately or severely emetogenic, What does it involve? Participants enrolled in this trial will be randomly allocated (by chance) to receive either 1.2g ginger supplementation or a placebo per day in capsule form for five days of each of the first three chemotherapy cycles. Participants will complete a number of questionnaires relating to quality of life, control of nausea and vomiting and fatigue at baseline prior to commencing supplementation and five days after each of the first three chemotherapy cycles. It is hoped that the findings of this trial will provide information on the efficacy of supplemental ginger for chemotherapy-induced nausea and vomiting for cancer patients.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria5

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 Criteria17

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:
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 (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.

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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.