Ginger for Colorectal Cancer Prevention

University of Michigan

Status and phase: Completed; Phase 2

Conditions: Colorectal Cancer

Treatments: Drug: Ginger Root Extract (Pure Encapsulations); Dietary Supplement: Placebo Capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT01344538

Ginger-01HR

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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:

1. a history of peptic ulcer disease, gastrointestinal bleeding from gastric or duodenal ulcers, or gastrin secreting tumors;
2. pregnant or lactating women;
3. history of cardiovascular disease;
4. lactose intolerance;
5. or an allergy to ginger
6. 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups, including a placebo group

Ginger Root Extract

Experimental group

Treatment:

Drug: Ginger Root Extract (Pure Encapsulations)

Lactose Capsule

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo Capsule