Chemotherapy-induced Nausea and VomitingPhase 2NCT02390648
Efficacy of Ginger as an Adjunctive Prophylaxis for Chemotherapy-induced Nausea and Vomiting
A Phase 2 study testing Ginger in people with Chemotherapy-induced Nausea and Vomiting, run by Mahidol University at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-induced Nausea and Vomiting
- What is being tested?
- Ginger
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteThailand
- Study dates
- Mar 2015to Feb 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Chemotherapy-induced Nausea and Vomiting
- Being tested
- Ginger, Placebo
- Medical subject headings
- Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GingerDrug
Ginger capsule (500 mg) taking twice a day by mouth during the first 5 days of chemotherapy cycle
PlaceboDrug
Placebo capsule taking twice a day by mouth during the first 5 days of chemotherapy cycle
| Study group | Role | What they receive |
|---|---|---|
| Ginger | Experimental | Ginger capsule (500 mg) taking twice a day by mouth during the first 5 days of chemotherapy cycle Receives: Drug: Ginger |
| Placebo | Placebo comparator | Placebo capsule taking twice a day by mouth during the first 5 days of chemotherapy cycle Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nausea score
Measured: The first 5 days of chemotherapy cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced Nausea and VomitingStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nopadol Soparattanapaisarn, MD, Principal investigator, Lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02390648
- Sponsor's protocol ID
- 732/2557(EC1)
- Status last verified
- Mar 2016
- First submitted
- 11 Mar 2015
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Ginger as an Adjunctive Prophylaxis for Chemotherapy-induced Nausea and Vomiting: Randomised Double-blind Placebo-control Cross Over Study
- ClinicalTrials.gov ID
- NCT02390648
- Acronym / sponsor ID
- 732/2557(EC1)
- Conditions
- Chemotherapy-induced Nausea and Vomiting
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 17 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ginger | Experimental | Drug: GingerGinger capsule (500 mg) taking twice a day by mouth during the first 5 days of chemotherapy cycle |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo capsule taking twice a day by mouth during the first 5 days of chemotherapy cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GingerGinger capsule (500 mg) taking twice a day by mouth during the first 5 days of chemotherapy cycle | Drug | Ginger |
| PlaceboPlacebo capsule taking twice a day by mouth during the first 5 days of chemotherapy cycle | Drug | Placebo |
Primary outcome
Nausea score
Time frame: The first 5 days of chemotherapy cycle
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2016.
Related trials for Chemotherapy-induced Nausea and Vomiting
RecruitingPhase 4
BMT-08: A Comparative Effectiveness Study of Transdermal Granisetron to Ondansetron
Nausea With Vomiting Chemotherapy-Induced
RecruitingPhase 2
A Study to Evaluate LY3537021 for the Treatment of Nausea and Vomiting Caused by Chemotherapy in Adults With Cancer
Nausea, Vomiting
RecruitingPhase 2
Personalized Antiemetic Regimen According to Patients' Pharmacogenetic Profile
Breast Cancer
RecruitingObservational study
HR20013 for the Prevention of Nausea and Vomiting in Patients With Cancer: A Real-World Study
Chemotherapy-Induced Nausea and Vomiting (CINV), Nausea
RecruitingPhase 1
A Study to Compare the Bioavailability of Ondansetron Following Nasal (NS003) and IV Administration in Healthy Adults
Chemotherapy-Induced Nausea and Vomiting (CINV), Radiotherapy-induced Nausea and Vomiting (RINV)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nopadol Soparattanapaisarn, MD principal investigator
Lecturer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ginger in people with Chemotherapy-induced Nausea and Vomiting, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nausea score (time frame: The first 5 days of chemotherapy cycle). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2016.