Inositol in Preventing Colorectal Cancer in Patients With Colitis-Associated Dysplasia

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01111292
• Date of registration: 24/04/2010
• Prospective Registration: Yes
• Primary sponsor: National Cancer Institute (NCI)
• Public title: Inositol in Preventing Colorectal Cancer in Patients With Colitis-Associated Dysplasia
• Scientific title: Myo-Inositol Chemoprevention in Colitis-Associated Dysplasia
• Date of first enrolment: October 2010
• Target sample size: 5
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01111292
• Study type: Interventional
• Phase: Phase 1/Phase 2

Countries of recruitment

United States

Contacts

• Name: Seema Khan
• Affiliation: Northwestern University

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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immediately; if she is pregnant, she will be immediately withdrawn from the study and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

Exclusion Criteria:

- 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Colon Carcinoma

Dysplasia in Crohn Disease

Low Grade Dysplasia in Ulcerative Colitis

Rectal Carcinoma

Intervention(s)

Drug: Inositol

Other: Placebo

Primary Outcome(s)

The Effect of Myo-inositol (Inositol) on P-ß-catenin Staining in Areas of Low Grade Dysplasia in Subjects With Known Colitis-induced Low Grade Dysplasia. [Time Frame: Baseline to 90 days]

Secondary ID(s)

CDR0000671302

N01CN35157

NWU09-13-02

NCI-2011-01434

NCI09-13-02

P30CA060553

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 12/07/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01111292