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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase II Randomized Study of Inositol for the Prevention of Lung Cancer in Current or Former Smokers With Bronchial Dysplasia

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Biomarker/Laboratory analysis, Prevention Active 45 to 79 NCI MAYO-MAY06-8-01 MAY06-8-01, NCT00783705

Trial Description

Purpose:

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.

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

Eligibility:

Eligibility criteria include the following:

• 45 to 79 years old
• Has smoked one pack of cigarettes a day for at least 30 years, two packs a day for at least 15 years, or three packs a day for at least 10 years
• No current lung cancer
• No previous surgery to remove all or part of a lung
• No previous organ transplant
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will be randomly assigned (have an equal chance of being placed) to one of two treatment groups.

Patients in group one will receive inositol by mouth once a day for 2 weeks and then twice a day for up to 6 months.

Patients in group two will receive a placebo by mouth once a day for 2 weeks and then twice a day for up to 6 months.

Patients will undergo bronchoscopy with bronchial lavage, bronchial brushings, and biopsies, imaging procedures, and blood sample collection at the beginning of the study and after finishing treatment for laboratory studies.

After finishing treatment, patients will be evaluated within 1 month.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

Mayo Clinic Cancer Center

Paul Limburg, MD, MPH, Principal investigator		Ph: 507-284-2511
Stephen Lam, MD, Protocol chair		Ph: 604-675-8089; 800-663-3333

U.S.A.
Minnesota
	Rochester
	Mayo Clinic Cancer Center
		Clinical Trials Office - All Mayo Clinic Locations	Ph:  507-538-7623

Registry Information
Official Title		Phase IIb Randomized Comparative Study of the Efficacy and Safety of Myo-inositol versus Placebo in Smokers with Bronchial Dysplasia
Trial Start Date		2008-11-03
Trial Completion Date		2009-10-30 (estimated)
Registered in ClinicalTrials.gov		NCT00783705
Date Submitted to PDQ		2008-10-15
Information Last Verified		2008-12-28