Evaluation of the Effect of Zingiber Officinalis on Nausea and Vomiting in Patients Receiving Cisplatin Based Regimens

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2009-09-30

Brief Summary

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The purpose of this study is to determine whether powdered ginger root (encapsulated ginger) is effective for reducing the frequency, duration and severity of both acute and delayed nausea and vomiting.

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Detailed Description

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Conditions

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Nausea Vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type ACTIVE_COMPARATOR

Ginger

Intervention Type DIETARY_SUPPLEMENT

Capsule, 1000 mg, BID, 3 days

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Capsule, 1000 mg, BID, 3 days

Interventions

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Ginger

Capsule, 1000 mg, BID, 3 days

Intervention Type DIETARY_SUPPLEMENT

Placebo

Capsule, 1000 mg, BID, 3 days

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Must be able to give written informed consent.
* Have a diagnosis of cancer and currently receiving chemotherapy containing cisplatin (any dose).
* Scheduled to receive antiemetics: granisetron (kytril), hydrocortisone.
* Must be able to complete study questionnaires.
* Must be able to swallow capsules.

Exclusion Criteria

* Have no clinical evidence of current or impending bowel obstruction.
* Concurrent radiotherapy that is classified as high or intermediate risk of causing emesis.
* Pregnant or lactating.
* Patients taking therapeutic doses of coumadin (individuals on low-dose to maintain peripheral or central venous catheters are allowed), aspirin (individuals taking low-dose 80mg aspirin are allowed), or heparin.
* Patients with a history of a bleeding disorder(s) in past 6 months and those experiencing thrombocytopenia.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No