A phase I study of myo-inositol for lung cancer chemoprevention.

Abstract

INTRODUCTION:

A phase I, open-label, multiple dose, dose-escalation clinical study was conducted to assess the safety, tolerability, maximum tolerated dose, and potential chemopreventive effect of myo-inositol in smokers with bronchial dysplasia.

MATERIALS AND METHODS:

Smokers between 40 and 74 years of age with >or= 30 pack-years of smoking history and one or more sites of bronchial dysplasia were enrolled. A dose escalation study ranging from 12 to 30 g/d of myo-inositol for a month was first conducted in 16 subjects to determine the maximum tolerated dose. Ten new subjects were then enrolled to take the maximum tolerated dose for 3 months. The potential chemopreventive effect of myo-inositol was estimated by repeat autofluorescence bronchoscopy and biopsy.

RESULTS:

The maximum tolerated dose was found to be 18 g/d. Side effects, when present, were mild and mainly gastrointestinal in nature. Using the regression rate of the placebo subjects from a recently completed clinical trial with the same inclusion/exclusion criteria as a comparison, a significant increase in the rate of regression of preexisting dysplastic lesions was observed (91% versus 48%; P = 0.014). A statistically significant reduction in the systolic and diastolic blood pressures by an average of 10 mm Hg was observed after taking 18 g/d of myo-inositol for a month or more.

CONCLUSION:

myo-Inositol in a daily dose of 18 g p.o. for 3 months is safe and well tolerated. The potential chemopreventive effect as well as other health benefits such as reduction in blood pressure should be investigated further.

• Authors: Stephen Lam, Annette McWilliams, Jean LeRiche, Calum MacAulay, Lee Wattenberg, Eva Szabo
• Journal: Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology (Cancer Epidemiol Biomarkers Prev) Vol. 15 Issue 8 Pg. 1526-31 (Aug 2006) ISSN: 1055-9965 [Print] United States
• PMID: 16896044 (Publication Type: Clinical Trial, Phase I, Journal Article, Research Support, N.I.H., Extramural)

Chemical References

• Vitamin B Complex
• Inositol

Topics

• Adult
• Aged
• Blood Pressure (drug effects)
• Body Weight (drug effects)
• Chemoprevention
• Dose-Response Relationship, Drug
• Female
• Humans
• Inositol (therapeutic use)
• Lung Neoplasms (drug therapy, prevention & control)
• Male
• Maximum Tolerated Dose
• Middle Aged
• Vitamin B Complex (therapeutic use)