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

Chemotherapy-induced Nausea and Vomiting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02390648
• Other study ID #: 732/2557(EC1)
• Status: Completed
• Phase: Phase 2
• First received: March 11, 2015
• Last updated: March 15, 2016
• Start date: March 2015
• Est. completion date: February 2016

Study information

• Verified date: March 2016
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Chemotherapy-induced Nausea and Vomiting
• Nausea
• Vomiting

Intervention

Drug:
• Ginger
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

Locations

Country	Name	City	State
Thailand	Siriraj Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nausea score		The first 5 days of chemotherapy cycle	No