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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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02390648
Enrollment
34
Registered
2015-03-17
Start date
2015-03-31
Completion date
2016-02-29
Last updated
2016-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chemotherapy-induced Nausea and Vomiting

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.

Interventions

DRUGGinger

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

DRUGPlacebo

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

Sponsors

Mahidol University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Nausea scoreThe first 5 days of chemotherapy cycle

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026