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

Primary Purpose

Chemotherapy-induced Nausea and Vomiting

Status

Completed

Phase

Phase 2

Locations

Thailand

Study Type

Interventional

Intervention

Ginger

Placebo

About this trial

This is an interventional supportive care trial for Chemotherapy-induced Nausea and Vomiting

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Siriraj Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ginger

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Nausea score

Secondary Outcome Measures

Full Information

NCT ID

NCT02390648

First Posted

March 11, 2015

Last Updated

March 15, 2016

Sponsor

Mahidol University

1. Study Identification

Unique Protocol Identification Number

NCT02390648

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Completed

Study Start Date

March 2015 (undefined)

Primary Completion Date

February 2016 (Actual)

Study Completion Date

February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mahidol University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chemotherapy-induced Nausea and Vomiting

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

34 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ginger

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Ginger

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Nausea score

Time Frame

The first 5 days of chemotherapy cycle

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nopadol Soparattanapaisarn, MD

Organizational Affiliation

Lecturer

Official's Role

Principal Investigator

Facility Information:

Facility Name

Siriraj Hospital

City

Bangkok

ZIP/Postal Code

10700

Country

Thailand

12. IPD Sharing Statement

Learn more about this trial

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

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