Inositol in Preventing Lung Cancer in Current or Former Smokers With Bronchial Dysplasia

Completed · Phase 2 · Has a placebo group

Conditions studied: Non-small Cell Lung Cancer, Squamous Lung Dysplasia

In brief

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 the use of certain drugs to keep cancer from forming. The use of inositol may prevent lung cancer. It is not yet known whether inositol is more effective than a placebo in preventing lung cancer in smokers with bronchial dysplasia.

Key facts

Study ID

NCT00783705

Run by

National Cancer Institute (NCI)

People needed

85

Starts

2008-11-01

Expected to finish

2014-05-01

Last updated by the study team

2017-12-05

Who can join

Age: 45 and older, up to 79. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Mayo Clinic in Arizona — Scottsdale, Arizona, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Albuquerque Veterans Administration Medical Center — Albuquerque, New Mexico, United States
• BCCA-Vancouver Cancer Centre — Vancouver, British Columbia, Canada

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.