Efficacy of Ginger as an Adjunctive Prophylaxis for Chemotherapy-induced Nausea and Vomiting

Mahidol University

Status and phase

Completed

Phase 2

Conditions

Chemotherapy-induced Nausea and Vomiting

Treatments

Drug: Placebo

Drug: Ginger

Study type

Interventional

Funder types

Other

Identifiers

NCT02390648

732/2557(EC1)

Details and patient eligibility

About

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.

Enrollment

34 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Histologically or cytologically confirmed breast cancer patient
Received AC regimen chemotherapy (Doxorubicin + Cyclophosphamide) and has nausea score at least 40/100 VAS or has vomiting
Expect to receive at least 2 further cycles of AC regimen chemotherapy
Provide informed consent

Exclusion criteria

Pregnancy or lactation
Has nausea or vomiting during 24 hours before chemotherapy
Has other causes of nausea or vomiting eg. brain metastasis, gut obstruction, hepatitis or recent abdominal or pelvic irradiation within 1 week before chemotherapy
Received any chemotherapy regimen other than AC regimen
Allergic or intolerance to ginger