Folate-Depleted Diet Compared With Folate-Supplemented Diet in Preventing Colorectal Cancer in Patients at High Risk for Colorectal Cancer

NCT00096330 | Completed Phase 1 DMC

• 6 other identifiers: CDR0000393455P30CA016056RUH-PHO-0514-0404RPCI-EPR-20703AECM-0401022ENEMCH-6060
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Chemoprevention therapy is the use of certain agents to try to prevent the development of cancer. The use of folic acid may be effective in preventing colorectal cancer. Eating a diet rich in folic acid may prevent the development of colorectal cancer. PURPOSE: This randomized phase I trial is studying how well a folate-depleted diet works compared to a folate-supplemented diet in preventing colorectal cancer in patients who are at high risk for developing colorectal cancer.

Conditions

Colorectal Cancer

Keywords

colon cancer; rectal cancer

Outcome Measures

Primary Outcomes (1)

• •Analyze the effects of a folate-depleted vs a folate-supplemented diet on folate-related DNA endpoints

  pre and post treatment

Interventions

dietary intervention DIETARY_SUPPLEMENT

oral folic acid supplementation once daily on days 57-84

folic acid DIETARY_SUPPLEMENT

oral folic acid supplementation once daily on days 1-56.

Eligibility Criteria

• Age: 40 Years - 72 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Healthy persons at increased risk for colorectal neoplasia due to 1 of the following reasons: * Personal history of colorectal adenomatous polyps * Family history of colorectal adenoma or adenocarcinoma * No history of multiple family members with colorectal neoplasia that is suggestive of dominant hereditary neoplasia PATIENT CHARACTERISTICS: Age * 40 to 72 Performance status * Ambulatory Life expectancy * At least 6 months Hematopoietic * No excessive bleeding or coagulation disorder Hepatic * ALT or AST ≤ 2 times upper limit of normal * No unexplained elevated alkaline phosphatase Renal * Creatinine ≤ 2.0 mg/dL Cardiovascular * Homocysteine concentration ≤ 17um/L * No sustained blood pressure \> 150/95 mm Hg for 3 consecutive readings Other * Vitamin B\_12 ≥ 250 pg/mL * Folate level ≤ 20 mg/dL * HIV negative * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 4 weeks after study participation * No intestinal malabsorption or inflammatory bowel disease * No prior malignancy except nonmelanoma skin cancer * No calcium metabolism abnormalities or predisposing conditions, such as hyperparathyroidism * No untreated hyperthyroidism * No untreated insulin-requiring diabetes mellitus * No daily alcohol intake \> 2 ½ shot glasses of whiskey or three 8 ounce glasses of beer or wine * No other serious illness that might limit life expectancy to \< 6 months PRIOR CONCURRENT THERAPY: Biologic therapy * None Chemotherapy * None Endocrine therapy * No concurrent hormone replacement therapy, including oral, transplanted, or injected contraceptives * Concurrent thyroid hormone replacement is allowed as long as the patient is euthyroid for 3 months Radiotherapy * None Surgery * No prior gastrointestinal surgery, including gastrectomy or small or large bowel resections * Prior appendectomy or surgery of the esophagus allowed Other * More than 3 months since regular ingestion of ≥ 650 mg per day of aspirin (≥ 2 tablets of 325 mg regular strength OR \> 1 tablet of 500 mg extra strength aspirin) * More than 3 months since regular daily ingestion of nonsteroidal anti-inflammatory drugs * At least 1 month since vitamin, mineral, or herbal supplementation * No other concurrent vitamin, mineral, or herbal supplementation * No concurrent anticoagulants * No concurrent sterol-binding resins (i.e., cholestyramine) * No other concurrent investigational drugs or medications that might alter rectal mucosal proliferation, folate metabolism, or renal/hepatic impairment * No concurrent weight control medications * No concurrent supplemental folate preparations containing \> 400 mcg of folic acid per day * No concurrent lipid-lowering medications * The following concurrent statin drugs are allowed provided patient has been taking a stable dose for ≥ 1 month: * Atorvastatin 10 or 20 mg/day * Fluvastatin 20 or 40 mg/day * Lovastatin 10 or 20 mg/day * Pravastatin 10 or 20 mg/day * Simvastatin 5 or 10 mg/day

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Interventions

Diet Therapy; Folic Acid

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

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• James Marshall, PhD

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2004
• First Posted: November 9, 2004
• Study Start: September 1, 2004
• Primary Completion: February 1, 2007
• Study Completion: March 1, 2008
• Last Updated: January 13, 2014

Record last verified: 2014-01

Locations

US (1)