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

Phase 2

Completed

• Conditions: Chemotherapy-induced Nausea and Vomiting
• Interventions: Drug: Placebo; Drug: Ginger

• Registration Number: NCT02390648
• Lead Sponsor: Mahidol University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-03-11
• Study First Submitted QC: 2015-03-11
• Study First Posted: 2015-03-17
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-15
• Last Update Posted: 2016-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo capsule taking twice a day by mouth during the first 5 days of chemotherapy cycle
Ginger	Ginger	Ginger capsule (500 mg) taking twice a day by mouth during the first 5 days of chemotherapy cycle

Primary Outcome Measures

Name	Time	Method
Nausea score	The first 5 days of chemotherapy cycle

Trial Locations

Locations (1)

Siriraj Hospital; 🇹🇭 Bangkok, Thailand