Ginger for Colorectal Cancer Prevention
This study has been completed.
Sponsor:
University of Michigan Health System
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
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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 Health System:
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:
- 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
Contacts and Locations
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 Health System
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 Health System:
|
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 May 16, 2013