None listed
Conditions
Brief summary
This study aims to gather evidence on the mechanisms of action and optimal dose of ginger for chemotherapy-induced nausea and vomiting (CINV), one of the most distressing and common side-effects for people undergoing chemotherapy. Who is it for? You may be eligible for this study if you are an adult scheduled to undergo intravenous (IV) chemotherapy for any type of cancer, and have been deemed to be at moderate to high risk of nausea and vomiting. Study details Participants will be randomly allocated to receive either standard care, or low dose or high dose oral ginger supplements at the beginning of chemotherapy infusion. This will occur on a single test day, with outcome data collected using a novel technique called Body Surface Gastric Mapping (BSGM) in the baseline (fasting) states as well as during chemotherapy infusion. It is hoped that findings will guide the optimal ginger dose to improve the management of CINV and assist in the future application of BSGM as a non-invasive, low cost, and quick measure of CINV treatments.
Interventions
The intervention will occur at one single time point and the study duration is for one single calendar day.
Intervention Groups 2 and 3 will receive standard care (including prescribed anti-emetic medication) in addition to a highly refined, standardised ginger root powder supplement in capsule form for oral consumption as a single dose (one time only) at the commencement of chemotherapy infusion. The ginger extract is manufactured by an independent company that will have no involvement in the
The intervention will occur at one single time point and the study duration is for one single calendar day. Intervention Groups 2 and 3 will receive standard care (including prescribed anti-emetic medication) in addition to a highly refined, standardised ginger root powder supplement in capsule form for oral consumption as a single dose (one time only) at the commencement of chemotherapy infusion. The ginger extract is manufactured by an independent company that will have no involvement in the study. The 300mg ginger root powder capsule will be standardised to contain 7% bioactive compounds (gingerols and shogaols). Group 2 (low dose ginger) will receive one capsule (300mg of ginger root, 21mg of bioactive compounds [gingerols and shogaols]). Group 3 (high dose ginger) will receive two capsules (600mg of ginger root, 42mg of gingerols/shogaols). All participants will be required to have fasted (food and drinks) for 4 hours prior to the test commencing (water is okay). All participants will be given a meal to consume after 30-minutes of baseline data has been captured. This meal will be standardised to contain similar energy and macronutrient contents and will meet any special dietary requirements or preferences of participants. Adherence to supplement consumption will be noted by the investigator who administered the intervention and test. Adherence will be noted as the number of supplement capsules consumed as per the protocol (0, 1, or 2 capsules).
Sponsors
Queensland University of Technology
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
People undergoing chemotherapy (Groups 1-3): Inclusion criteria: • Moderate to high risk of emesis (a score of 13 or more on the CINV Risk Tool). • Scheduled to undergo intravenous chemotherapy for any type of cancer. • Naïve and non-naïve to chemotherapy. • Aged 18 years or above. • Body Mass Index (BMI) <35 kg/m2 (as the Gastric Alimetry results may be unreliable for patients with BMI > 35 kg/m2). • Willing to adhere to controlled background lifestyle (no other ginger, no alcohol, no use of self-prescribed nausea therapiesa within 48 hours of the test). • Willing to not have any food and drinks other than water for 4 hours or more before the test. • Willing to not smoke or vape during the test period. • Able to remain in a relaxed, reclined position for the test duration. Matched healthy Controls (Group 4): Inclusion criteria: • Age and sex matched to intervention groups 1-3. • BMI <35 kg/m2 (as the Gastric Alimetry results may be unreliable for patients with BMI > 35 kg/m2). • Willing to adhere to controlled background lifestyle (no ginger, alcohol, or use of self-prescribed nausea therapies) from within 48-hours prior to the test. • Willing to not have any food and drinks other than water for 4 hours or more before the test and to not smoke or vape during the test period. • Able to remain in a relaxed, reclined position for the test duration.
Exclusion criteria
People undergoing chemotherapy (Groups 1-3): Exclusion criteria: • Severe cognitive impairment preventing ability to fully understand the purpose of the study, adhere to the study procedures, and complete data collection forms. • Pregnant or breastfeeding women. • High risk of abnormal or altered gastric motility (e.g., medications [e.g., opiates, sedatives, antispasmodics] or electrolyte imbalances causing gastrointestinal symptoms, cancer of the gastrointestinal tract and ancillary organs [mouth, oesophagus, stomach, intestine, colon, colorectal, rectal, pancreas, liver, gall bladder, bile duct, or other gastrointestinal cancer e.g., head and neck cancer], diabetes, delayed gastric emptying [other reasons], brain cancer and metastases, intestinal obstruction). • Unable to receive gastric motility assessment via the Gastric Alimetry (e.g., history of skin sensitivity to adhesives or hydrogels on any part of the body; and skin conditions, fragile skin, wounds, abrasions, infection, or inflammation in the abdominal skin areas intended for Array placement). • Unable to consume test product (swallowing concerns, allergic reactions, etc). • Concurrent radiotherapy, a known risk factor for nausea and vomiting. • Severe thrombocytopenia (platelets <50 x 10^9/L). • Participants with other factors deemed by the Investigators as not suitable for the trial. Matched healthy Controls (Group 4): Exclusion criteria: • Severe cognitive impairment preventing ability to fully understand the purpose of the study, adhere to the study procedures, and complete data collection forms. • Pregnant or breastfeeding women. • High risk of abnormal or altered gastric motility (e.g., medications [e.g., opiates, sedatives, antispasmodics] or electrolyte imbalances causing gastrointestinal symptoms, cancer of the gastrointestinal tract and ancillary organs [pancreas, liver, etc], diabetes, delayed gastric emptying [other reasons], brain cancer and metastases, intestinal obstruction). • Unable to receive gastric motility assessment via the Gastric Alimetry (e.g., history of skin sensitivity to adhesives or hydrogels on any part of the body; and skin conditions, fragile skin, or wounds, abrasions, infection, or inflammation in the abdominal skin areas intended for Array placement). • Any other medical condition or routine use of medications, recreational drugs, tobacco, or vaping. • Moderate to severe gastrointestinal symptoms (score of 3 or more on any question of the gastrointestinal system rating scale [GSRS]). • Participants with other factors deemed by the Investigators as not suitable for the trial.
Outcome results
None listed