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A Phase I Study of myo-Inositol for Lung Cancer Chemoprevention

Departments of ¹ Respiratory Medicine, Pathology, and Cancer Imaging, British Columbia Cancer Agency and the University of British Columbia, Vancouver, British Columbia, Canada; ² University of Minnesota, Minneapolis, Minnesota; and ³ Lung and Upper Aerodigestive Cancer Research Group, Division of Cancer Prevention, National Cancer Institute, Bethesda, Maryland

Requests for reprints: Stephen Lam, Department of Cancer Imaging, British Columbia Cancer Agency, 675 West 10 Avenue, Vancouver, British Columbia, Canada V5Z 1L3. Phone: 604-675-6094; Fax: 604-675-8099. E-mail: slam{at}bccancer.bc.ca

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 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. (Cancer Epidemiol Biomarkers Prev 2006;15(8):1526–31)

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