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

NCT ID: NCT02390648

Last Updated: 2016-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2016-02-29

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.

Conditions

Chemotherapy-induced Nausea and Vomiting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Ginger

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

Group Type: EXPERIMENTAL

Ginger

Intervention Type: DRUG

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

Placebo

Placebo capsule taking twice a day by mouth during the first 5 days of chemotherapy cycle

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo capsule taking twice a day by mouth during the first 5 days of chemotherapy cycle

Interventions

Ginger

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

Intervention Type: DRUG

Placebo

Placebo capsule taking twice a day by mouth during the first 5 days of chemotherapy cycle

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nopadol Soparattanapaisarn, MD

Role: PRINCIPAL_INVESTIGATOR

Lecturer

Locations

Siriraj Hospital

Bangkok, , Thailand

Countries

Thailand

Other Identifiers

732/2557(EC1)

Identifier Type: -

Identifier Source: org_study_id