Inositol in Preventing Colorectal Cancer in Patients With Colitis-Associated Dysplasia
Stopped early · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Colon Carcinoma, Dysplasia in Crohn Disease, Low Grade Dysplasia in Ulcerative Colitis, Rectal Carcinoma
In brief
This pilot, randomized phase I/II trial studies how well inositol works in preventing colorectal cancer in patients with abnormal cells (dysplasia) associated with inflammation of the colon (colitis). Patients with colitis-associated dysplasia may have an increased risk of developing colorectal cancer. Inositol is a vitamin-like substance that may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Key facts
- Study ID
- NCT01111292
- Run by
- National Cancer Institute (NCI)
- People needed
- 5
- Starts
- 2010-10-01
- Expected to finish
- 2014-09-01
- Last updated by the study team
- 2016-07-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Participants must have ulcerative colitis or Crohn's disease with low grade dysplasia or polyploid dysplasia or have a history of dysplasia and increased positive beta-catenin levels confirmed by a consensus of the study pathologists (2 of 2, or 2 of 3)
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Absolute neutrophil count (ANC) > 1,500/uL
- Platelets > 100,000/uL
- Total bilirubin within normal institutional limits
- Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT]/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT] =< 1.5 times upper limit of normal
- Creatinine within normal institutional limits
- International normalized ratio (INR) < 1.5
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) from the time of baseline pregnancy test, throughout the duration of the study, and for 1 month following cessation of study drug; females must begin adequate contraception immediately following screening pregnancy test; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately; if she is pregnant, she will be immediately withdrawn from the study and followed until the birth of the child
- Ability to understand and the willingness to sign a written informed consent document
You may not qualify if…
- Subjects with life-threatening medical conditions that would preclude study treatment intervention and colonoscopy
- Participants may not be receiving any other investigational agents
- History of allergic reactions to rice or compounds of similar chemical or biologic composition to myo-inositol (i.e., urticaria, dermatologic reaction)
- Use of medications known to elevate serum blood glucose; participants on steroids are still eligible, as they will be monitored weekly for fasting blood glucose
- Participants with dysplasia-associated lesion or mass (DALM), high-grade dysplasia or invasive colonic carcinoma are excluded
- Uncontrolled intercurrent illness including, but not limited to
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Chronic renal failure
- Chronic renal insufficiency
- Psychiatric illness or social situations that would limit compliance with study requirements
- Prior treatment with myo-inositol
- History of systemic chemotherapy within 18 months of screening
- Subjects taking valproic acid and/or lithium
- Diabetes mellitus
- History of total proctocolectomy
- Concomitant primary sclerosing cholangitis (PSC)
- Pregnant or lactating subjects are excluded
Where it is running
- Northwestern University — Chicago, Illinois, United States
- University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States
- Mount Sinai Medical Center — New York, New York, United States
Full record on ClinicalTrials.gov
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