Chemotherapy-induced nausea and vomiting in gynecologic cancer patients receiving platinum-based chemotherapy Ginger Chemotherapy-Induced Nausea and Vomiting Platinum Compounds Randomized Controlled Trials
Conditions
Interventions
Patients receive the IP (ginger extract) as an adjunct to standard antiemetic care.
Dosage: A total of 600 mg of ginger extract per day, divided into four tablets, with each tablet containing 150 mg o
Experimental Drug,Placebo Comparator Other
Ginger Extract Tablet,Placebo
Sponsors
Specialty Innovation Company Limited
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with gynecological cancer(s) 2. Patients receiving Carboplatin and Paclitaxel chemotherapy cycles as part of their treatment 3. Patients who understand the aim and content of the trial and can perform Visual Analog Scale (VAS) assessments
Exclusion criteria
Exclusion criteria: 1. Patients with gastrointestinal, liver, brain, or spinal metastases 2. Patients with Eastern Cooperative Oncology Group (ECOG) Performance Status of more than 2 3. Patients with history of bowel obstruction(s), including partial or complete obstructions 4. Patients who have received abdominal radiation within 14 days prior to screening/enrollment 5. Patients who have received medications outside the specified standard antiemetic regimen within 17 days prior to screening/enrollment, unless the patient has used a rescue medication for breakthrough nausea and vomiting in the class of 5-HT3 antagonists, metoclopramide, or olanzapine 6. Patients who have taken anticoagulant and antiplatelet medications within 30 days prior to screening and enrollment. 7. Patients with underlying liver condition(s) defined as alanine transaminase and/or aspartate transaminase of at least 2.5 times the upper limit of the normal range 8. Patients with underlying renal condition(s) defined as an estimated glomerular filtration rate of less than 60 9. Patients with a history of allergies to ginger or ginger extract
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Nausea severity Assessments will be conducted four times daily (prior to breakfast, lunch, dinner and bedtime) for the initial 120 hours during each treatment cycle Visual Analog Score,Quality of life Assessments will be conducted on Days 1 and 22 and Days 7 and 28 for pre- and post-treatment assessment, respectively SF-36,Emesis Asessments will be conducted daily for the initial 120 hours during each treatment cycle Patient-reported occurrence, frequency, and timing,Rescue medication usage Assessments will be conducted daily for the initial 120 hours during each treatment cycle Patient-reported occurrence, timing, and reason for usage | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events Assessments will be conducted daily for the initial 120 hours during each treatment cycle Patient-reported and study personalled evaluated incidence, severity, and relation of event to the IP | — |
Countries
Thailand
Contacts
Public ContactVuthinun Achariyapota
Faculty of Medicine Siriraj Hospital, Mahidol University
Outcome results
None listed