Ginger for Colorectal Cancer Prevention

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Suzanna Zick, University of Michigan Health System
ClinicalTrials.gov Identifier:
NCT01344538
First received: April 27, 2011
Last updated: January 21, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer
Drug: Ginger Root Extract (Pure Encapsulations)
Dietary Supplement: Placebo Capsule
Phase 2

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

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Determine changes in levels from baseline of prostaglandin E2 [ Time Frame: Baseline and day 28 ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: April 2007
Study Completion Date: December 2012
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ginger Root Extract Drug: Ginger Root Extract (Pure Encapsulations)
2.0 g per day (10:1 extract)
Placebo Comparator: Lactose Capsule Dietary Supplement: Placebo Capsule
2.0 g per day

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01344538

Locations
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48105
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Suzanna M Zick, ND, MPH University of Michigan
  More Information

Publications:
Responsible Party: Suzanna Zick, Research Associate Professor, University of Michigan Health System
ClinicalTrials.gov Identifier: NCT01344538     History of Changes
Other Study ID Numbers: Ginger-01HR
Study First Received: April 27, 2011
Last Updated: January 21, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by University of Michigan:
ginger
Zingiber officinale
Cancer Risk Reductive
Eicosanoids
Colorectal Cancer
Inflammation

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on September 18, 2014