CClinicalTrials.gg
CompletedNCT02390648Updated Mar 16, 2016

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

A Phase 2 interventional study of Ginger and Placebo in Chemotherapy-induced Nausea and Vomiting, sponsored by Mahidol University. Completed at 1 site in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-03-16.

Sponsored by Mahidol University · Phase 2, Interventional, and Supportive care

Phase
Phase 2
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Chemotherapy-induced Nausea and Vomiting

Browse trials for

03

In context

Nausea

822 studies on the registry are indexed under Nausea; 104 are open to participants now.

This study's enrollment of 34 is below the median of 115 across 703 interventional studies indexed under Nausea.

Browse Nausea studies →

Lead sponsor

Mahidol University is the lead sponsor of 730 studies on the registry; 118 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
34 participants (actual)

Study arms

  • Experimental
    Ginger

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

    Drug: Ginger

  • Placebo comparator
    Placebo

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

    Drug: Placebo

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

06

What researchers measure

Primary outcomes

  1. Nausea score

    Time frame: The first 5 days of chemotherapy cycle

07

Study locations

1 site
  • Siriraj Hospital
    Bangkok, 10700, Thailand
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 16, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02390648
Lead sponsor
Mahidol University
Responsible party
Sponsor
First posted
Mar 17, 2015
Start date
Mar 2015
Primary completion
Feb 2016
Completion
Feb 2016
Last update
Mar 16, 2016

Study contacts

Nopadol Soparattanapaisarn, MD
principal investigator · Lecturer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion