Clinical trial · Interventional
Inositol in Preventing Lung Cancer in Patients With Bronchial Epithelial Dysplasia Who Are Current or Former Smokers
A Phase I Study Of The Safety Of Myo-Inositol As A Chemopreventive Agent
NCT00061997CI-TRIAL-00003082completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Inositol may be effective in preventing the development of lung cancer in patients with bronchial epithelial dysplasia. PURPOSE: This phase I trial is studying the side effects and best dose of inositol in preventing lung cancer in current or former smokers with bronchial epithelial dysplasia.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Precancerous Condition | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| inositol | Dietary Supplement | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 74 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of persistent bronchial dysplasia despite regular twice-daily treatment with inhaled budesonide for 6 or 12 months on protocol BCCA-CIC-98-37 * Current or former smokers who have smoked at least 30 pack years * Sputum cells showing AIC atypia by computer-assisted image analysis * At least 2 abnormal sites on fluorescence bronchoscopy (red/green ratio at least 0.45) suspicious for bronchial dysplasia * At least 1 site confirmed by bronchial biopsy * Solitary dysplastic lesion allowed provided the diameter is greater than 1.5 mm * No invasive cancer on bronchoscopy or abnormal low-dose spiral CT scan suspicious for lung cancer PATIENT CHARACTERISTICS: Age * 40 to 74 Performance status * ECOG 0-1 Life expectancy * Not specified Hematopoietic * Hematologic function normal * No bleeding disorder Hepatic * Liver function normal * Liver enzymes no greater than upper limit of normal Renal * Renal function normal Cardiovascular * No unstable angina * No congestive heart failure Pulmonary * No acute or chronic respiratory failure * No acute bronchitis or pneumonia within the past month Other * Fasting glucose less than 144 mg/dL * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Willing to have a bronchoscopy * No schizophrenia * No bipolar disorder * No diabetes * No known reaction to topical xylocaine * No other medical condition that would jeopardize patient safety during study participation PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy Endocrine therapy * Not specified Radiotherapy * No prior radiotherapy Surgery * No prior surgery for lung cancer Other * No concurrent lithium
References
Publications (0)
Data not yet available
No reference posted for this study.