Ginger for Colorectal Cancer Prevention

NCT01344538 | Completed Phase 2 Results DMC

• 1 other identifier: Ginger-01HR
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Ginger Root Extract

EXPERIMENTAL

Drug: Ginger Root Extract (Pure Encapsulations)

Lactose Capsule

PLACEBO COMPARATOR

Dietary Supplement: Placebo Capsule

Interventions

Ginger Root Extract (Pure Encapsulations) DRUG

2.0 g per day (10:1 extract)

Ginger Root Extract

Placebo Capsule DIETARY_SUPPLEMENT

2.0 g per day

Lactose Capsule

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;.
• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48105, United States

Location

Related Publications (4)

• 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.

  PMID: 21990307 BACKGROUND

• 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.

  PMID: 23303903 RESULT

• 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.

  PMID: 23222413 RESULT

• 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.

  PMID: 24760534 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Inflammation

Interventions

ginger extract

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Suzanna M Zick
• Organization: University of Michigan

szick@umich.edu

734-998-9553

Study Officials

• Suzanna M Zick, ND, MPH

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate Professor

Study Record Dates

• First Submitted: April 27, 2011
• First Posted: April 29, 2011
• Study Start: April 1, 2007
• Primary Completion: May 1, 2011
• Study Completion: December 1, 2012
• Last Updated: August 11, 2016
• Results First Posted: August 11, 2016

Record last verified: 2016-06

Locations

US (1)