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Randomized Placebo-Controlled Study of Acarbose for Chemoprevention of Colonic Neoplasia in Patients with a History of Adenomatous Colon Polyps (Summary Last Modified 01/95)

Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
No phase specified Prevention Closed over 21 and under 80 MIBH-ACARBOSE
NCI-P94-0061

Objectives

I.  Determine whether intermediate markers of acarbose activity can be 
maintained in a 12-month trial (4 months acarbose, 4 months washout, and 4 
months placebo) and whether acarbose has long-term effects on the colonic 
microbial community and fecal excretion of fiber polysaccharides.

II.  Evaluate the effect of acarbose on the histologic markers of colonic 
mucosal differentiation.

Entry Criteria

Disease Characteristics:


Histologically confirmed previous or current adenomatous colon polyp 0.5 cm or
greater or 2 or more adenomatous polyps
  No hyperplastic polyps

Prior/Concurrent Therapy:


No surgical removal of part of intestine (except limited colon resection)

Patient Characteristics:


Age:
  Over 21 and under 80

Hematopoietic:
  Not specified

Hepatic:
  Not specified

Renal:
  Not specified

Other:
  No inflammatory bowel disease
  No diabetes
  No history of a bleeding disorder
  No antibiotics within 1 month prior to or after completion of drug or
     placebo treatment
  No more than 750 mg/day calcium supplement
  No more than 25,000 U/week vitamin D
  No regular use of bile salts
  No pregnant women

Expected Enrollment

Up to 50 patients will be entered to obtain 40 evaluable patients.  Study 
duration will be 2 years.

Outline

Randomized, double-blind, placebo-controlled, cross-over study.

Arm I:  Chemoprevention.  Acarbose.

Arm II:  Control.  Placebo, PLCB.

Trial Contact Information

Trial Lead Organizations

Bassett Healthcare Regional Cancer Program at Mary Imogene Bassett Hospital

Gary Weaver, MD, Protocol chair
Ph: 607-547-3336; 800-227-7388

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.