Efficacy of Ginger as an Adjunctive Prophylaxis for Chemotherapy-induced Nausea and Vomiting
NCT02390648 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34
Last updated 2016-03-16
Summary
Breast cancer patient receiving AC regimen chemotherapy (Doxorubicin + Cyclophosphamide) who has nausea score from 40/100 VAS or vomiting after the first or second cycle of chemotherapy is recruited. The patient who meets the eligibility criteria and provides informed consent is randomised to receive either Ginger capsule (500 mg) or placebo taking twice a day by mouth during the first 5 days of chemotherapy cycle. The study drug will be switched on the subsequent cycle (i.e. the patient who received Ginger capsule will receive placebo and vice versa). The primary outcome is the nausea score and vomiting during the first 5 days of each chemotherapy cycle when receiving the study drug.
Conditions
- Chemotherapy-induced Nausea and Vomiting
Interventions
- DRUG
-
Ginger
Ginger capsule (500 mg) taking twice a day by mouth during the first 5 days of chemotherapy cycle
- DRUG
-
Placebo capsule taking twice a day by mouth during the first 5 days of chemotherapy cycle
Sponsors & Collaborators
-
Mahidol University
lead OTHER
Principal Investigators
-
Nopadol Soparattanapaisarn, MD · Lecturer
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- QUADRUPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-03-31
- Primary Completion
- 2016-02-29
- Completion
- 2016-02-29
Countries
- Thailand
Study Locations
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