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

NCT02390648 | Completed Phase 2

• 1 other identifier: 732/2557(EC1)
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Chemotherapy-induced Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

• Nausea score

  The first 5 days of chemotherapy cycle

Study Arms (2)

Ginger

EXPERIMENTAL

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

Drug: Ginger

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Ginger DRUG

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

Ginger

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Siriraj Hospital

Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Vomiting

Interventions

ginger extract

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nopadol Soparattanapaisarn, MD

  Lecturer

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2015
• First Posted: March 17, 2015
• Study Start: March 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: March 16, 2016

Record last verified: 2016-03

Locations

TH (1)