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

Efficacy of Ginger as an Adjunctive Prophylaxis for Chemotherapy-induced Nausea and Vomiting: Randomised Double-blind Placebo-control Cross Over Study

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.

Study Overview

• Status: Completed
• Conditions: Chemotherapy-induced Nausea and Vomiting
• Intervention / Treatment: Drug: Ginger; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 2

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10700
    • Siriraj Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ginger; Ginger capsule (500 mg) taking twice a day by mouth during the first 5 days of chemotherapy cycle	Drug: Ginger; Ginger capsule (500 mg) taking twice a day by mouth during the first 5 days of chemotherapy cycle
Placebo Comparator: Placebo; Placebo capsule taking twice a day by mouth during the first 5 days of chemotherapy cycle	Drug: Placebo; Placebo capsule taking twice a day by mouth during the first 5 days of chemotherapy cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Nausea score	The first 5 days of chemotherapy cycle

Collaborators and Investigators

• Sponsor: Mahidol University
• Investigators: Principal Investigator: Nopadol Soparattanapaisarn, MD, lecturer

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: March 11, 2015
• First Submitted That Met QC Criteria: March 11, 2015
• First Posted (Estimate): March 17, 2015

Study Record Updates

• Last Update Posted (Estimate): March 16, 2016
• Last Update Submitted That Met QC Criteria: March 15, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Nausea; Vomiting
• Other Study ID Numbers: 732/2557(EC1)