Clinical trial · Interventional
Inositol in Preventing Colorectal Cancer in Patients With Colitis-Associated Dysplasia
Myo-Inositol Chemoprevention in Colitis-Associated Dysplasia
NCT01111292CI-TRIAL-00022965terminatedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was closed prematurely due to poor accrual.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Carcinoma | Colon Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Dysplasia in Crohn Disease | — | UNRESOLVED | — |
| Low Grade Dysplasia in Ulcerative Colitis | — | UNRESOLVED | — |
| Rectal Carcinoma | Rectal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Inositol | Drug | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (inositol)
- description
- Beginning within 14 days after colonoscopy, patients receive inositol PO QD on days 1-14 and BID on days 15-90.
- interventionNames
- Drug: Inositol
- type
- PLACEBO_COMPARATOR
- label
- Arm II (placebo)
- description
- Beginning within 14 days after colonoscopy, patients receive placebo PO QD on days 1-14 and BID on days 15-90.
- interventionNames
- Other: Placebo
Primary outcomes (1)
- measure
- The Effect of Myo-inositol (Inositol) on P-β-catenin Staining in Areas of Low Grade Dysplasia in Subjects With Known Colitis-induced Low Grade Dysplasia.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.