Ginger for Colorectal Cancer Prevention

Study Overview
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Brief Summary
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The purpose of this study is to determine if ginger root extract when taken daily for 28 days is able to decrease levels of inflammatory chemicals called eicosanoids in the gut tissue of people who are at normal risk and those at increased of developing colorectal cancer compared to people taking placebo.

Official Title
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Phase II Study of the Effects of Ginger Root Extract on Eicosanoids in Colon Mucosa in People at Normal Risk for Colorectal Cancer

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Drug: Ginger Root Extract (Pure Encapsulations)
* Dietary Supplement: Placebo Capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Normal Risk: 18 years or older and in good health as defined by an unremarkable medical history, physical and screening blood work (chemistry screen, complete blood count) within 60 days of study entry. No chronic medication use was allowed and participants could not have taken aspirin or related NSAIDs during the study or 14 days before the first dose of the study medication. Participants also had to be classified as being at normal-risk for developing colorectal cancer. Normal-risk was defined as having: no first-degree relatives with colon cancer diagnosed before the age of 60; no personal history of colorectal cancer and no adenomas >1 cm in size or containing carcinoma in situ Exclusion Criteria for both Normal and Increased Risk for Colorectal Cancer: a history of peptic ulcer disease, gastrointestinal bleeding from gastric or duodenal ulcers, or gastrin secreting tumors; pregnant or lactating women; history of cardiovascular disease; lactose intolerance; or an allergy to ginger a history of familial colorectal cancer syndromes;. Inclusion Criteria Increased Risk: 18 years or older and in good health as defined by an unremarkable medical history, physical and screening blood work (chemistry screen, complete blood count) within 60 days of study entry. No chronic medication use was allowed and participants could not have taken aspirin or related NSAIDs during the study or 14 days before the first dose of the study medication. Participants also had to be classified as being at increased-risk for developing colorectal cancer. Increased-risk is defined as having at least one of the following: a first-degree relatives with colon cancer diagnosed before the age of 60; a personal history of early stage colorectal cancer and/or no adenomas >1 cm in size or containing carcinoma in situ

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ginger Root Extract<br> | Drug: Ginger Root Extract (Pure Encapsulations)<br>* 2.0 g per day (10:1 extract)<br>|
| Placebo Comparator: Lactose Capsule<br> | Dietary Supplement: Placebo Capsule<br>* 2.0 g per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate Whether 2.0g of Ginger Taken Daily, Standardized to 5%-Gingerols for Four Weeks Will Result in Bioactive Levels in Colonic Tissue Sufficient to Reduce Mucosal Prostaglandin E2 (PGE2), a Marker of Cyclooxygenase Function Versus Placebo. | % Change between baseline and day 28 in PGE2 levels standardized by protein | Baseline and day 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ginger, Zingiber officinale, Cancer Risk Reductive, Eicosanoids, Colorectal Cancer, Inflammation