Status:
COMPLETED
Inositol in Preventing Lung Cancer in Current or Former Smokers With Bronchial Dysplasia
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Non-small Cell Lung Cancer
Squamous Lung Dysplasia
Eligibility:
All Genders
45-79 years
Phase:
PHASE2
Brief Summary
This randomized phase II trial is studying inositol to see how well it works compared with a placebo in preventing lung cancer in current or former smokers with bronchial dysplasia. Chemoprevention is...
Detailed Description
PRIMARY OBJECTIVES: I. To evaluate the efficacy of myo-inositol (inositol) 9 grams by mouth twice a day for 6 months versus placebo to revert bronchial dysplasia in current/former smokers with or wit...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Histologically confirmed bronchial dysplasia in ≥ 1 site AND meets one of the following criteria:
- Current or former smoker with ≥ a 30 pack-year smoking history and no history of lung cancer
- Stage 0 or I non-small cell lung cancer (NSCLC) curatively treated by surgery (local ablation or resection), adjuvant chemotherapy, or radiotherapy with a ≥ 30 pack-year smoking history
- At least 6 months since prior surgery, adjuvant chemotherapy, or radiotherapy
- No current evidence of lung cancer by CT scan
- No non-calcified lung nodules ≥ 10 mm diameter on spiral CT scan unless cancer is ruled out by PET/CT scan or by biopsy
- ECOG performance status 0-1
- Hemoglobin normal
- Leukocyte count ≥ 3,000/mm³
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 1.5 times ULN
- ALT and AST ≤ 1.5 times ULN
- BUN ≤ 1.5 times ULN
- Chloride ≤ 1.5 times ULN
- Total CO\_2 ≤ 1.5 times ULN
- Sodium ≤ 1.5 times ULN
- Calcium ≤ 1.5 times ULN
- Potassium ≤ 1.5 times ULN
- Phosphorus ≤ 1.5 times ULN
- Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 30mL/min
- Fasting blood glucose normal
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No cancer within the past 3 years except stage 0 or I NSCLC, nonmelanomatous skin cancer, localized prostate cancer, carcinoma in situ of the cervix, or superficial bladder cancer that was treated \> 6 months ago
- No concurrent uncontrolled illness including, but not limited to, any of the following:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Severe chronic obstructive pulmonary disease requiring supplemental oxygen
- Uncontrolled hypertension
- Psychiatric illness or social situation that would limit compliance with study requirements
- No schizophrenia or bipolar disorder
- No diabetes
- No requirement for supplemental oxygen (continuous or intermittent)
- SaO\_2 ≥ 90% on room air
- No history of allergic reactions attributed to inositol
- No history of allergies to any ingredient in the study agent or placebo
- No other concurrent investigational agents
- At least 7 days since prior anticoagulant use (e.g., coumadin or heparin)
- More than 6 months since prior participation in another chemoprevention clinical trial
- No prior pneumonectomy
- No prior solid organ transplantation
- No concurrent lithium, carbamazepine, or valproate
- No concurrent use of other natural health products containing inositol
Exclusion
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT00783705
Start Date
November 1 2008
End Date
May 1 2014
Last Update
December 5 2017
Active Locations (4)
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1
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
2
Mayo Clinic
Rochester, Minnesota, United States, 55905
3
Albuquerque Veterans Administration Medical Center
Albuquerque, New Mexico, United States, 87108-5128
4
BCCA-Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6