Ginger for Colorectal Cancer Prevention

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01344538
• Other study ID #: Ginger-01HR
• Status: Completed
• Phase: Phase 2
• First received: April 27, 2011
• Last updated: January 21, 2013
• Start date: April 2007
• Est. completion date: December 2012

Study information

• Verified date: January 2013
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2012
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• Ginger Root Extract (Pure Encapsulations)
2.0 g per day (10:1 extract)

Dietary Supplement:
• Placebo Capsule
2.0 g per day

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

References & Publications (3)

Citronberg J, Bostick R, Ahearn T, Turgeon DK, Ruffin MT, Djuric Z, Sen A, Brenner DE, Zick SM. Effects of ginger supplementation on cell-cycle biomarkers in the normal-appearing colonic mucosa of patients at increased risk for colorectal cancer: results — View Citation

Jiang Y, Turgeon DK, Wright BD, Sidahmed E, Ruffin MT, Brenner DE, Sen A, Zick SM. Effect of ginger root on cyclooxygenase-1 and 15-hydroxyprostaglandin dehydrogenase expression in colonic mucosa of humans at normal and increased risk for colorectal cance — View Citation

Zick SM, Turgeon DK, Vareed SK, Ruffin MT, Litzinger AJ, Wright BD, Alrawi S, Normolle DP, Djuric Z, Brenner DE. Phase II study of the effects of ginger root extract on eicosanoids in colon mucosa in people at normal risk for colorectal cancer. Cancer Prev Res (Phila). 2011 Nov;4(11):1929-37. doi: 10.1158/1940-6207.CAPR-11-0224. Epub 2011 Oct 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine changes in levels from baseline of prostaglandin E2		Baseline and day 28	No