Back to results

Ginger for Colorectal Cancer Prevention

Primary Purpose

Colorectal Cancer

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Ginger Root Extract (Pure Encapsulations)

Placebo Capsule

About this trial

This is an interventional prevention trial for Colorectal Cancer focused on measuring ginger, Zingiber officinale, Cancer Risk Reductive, Eicosanoids, Colorectal Cancer, Inflammation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

University of Michigan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ginger Root Extract

Lactose Capsule

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01344538

First Posted

April 27, 2011

Last Updated

June 30, 2016

Sponsor

University of Michigan

1. Study Identification

Unique Protocol Identification Number

NCT01344538

Brief Title

Ginger for Colorectal Cancer Prevention

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Completed

Study Start Date

April 2007 (undefined)

Primary Completion Date

May 2011 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Michigan

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer

Keywords

ginger, Zingiber officinale, Cancer Risk Reductive, Eicosanoids, Colorectal Cancer, Inflammation

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ginger Root Extract

Arm Type

Experimental

Arm Title

Lactose Capsule

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Ginger Root Extract (Pure Encapsulations)

Intervention Description

2.0 g per day (10:1 extract)

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo Capsule

Intervention Description

2.0 g per day

Primary Outcome Measure Information:

Title

Description

% Change between baseline and day 28 in PGE2 levels standardized by protein

Time Frame

Baseline and day 28

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Suzanna M Zick, ND, MPH

Organizational Affiliation

University of Michigan

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Michigan

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48105

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

21990307

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.

Results Reference

background

PubMed Identifier

23303903

Citation

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 from a pilot, randomized, and controlled trial. Cancer Prev Res (Phila). 2013 Apr;6(4):271-81. doi: 10.1158/1940-6207.CAPR-12-0327. Epub 2013 Jan 9.

Results Reference

result

PubMed Identifier

23222413

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 cancer. Eur J Cancer Prev. 2013 Sep;22(5):455-60. doi: 10.1097/CEJ.0b013e32835c829b.

Results Reference

result

PubMed Identifier

24760534

Citation

Zick SM, Turgeon DK, Ren J, Ruffin MT, Wright BD, Sen A, Djuric Z, Brenner DE. Pilot clinical study of the effects of ginger root extract on eicosanoids in colonic mucosa of subjects at increased risk for colorectal cancer. Mol Carcinog. 2015 Sep;54(9):908-15. doi: 10.1002/mc.22163. Epub 2014 Apr 24.

Results Reference

derived

Learn more about this trial

Ginger for Colorectal Cancer Prevention

We'll reach out to this number within 24 hrs