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Inositol in Preventing Lung Cancer in Patients With Bronchial Epithelial Dysplasia Who Are Current or Former Smokers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00061997
Recruitment Status : Completed
First Posted : June 6, 2003
Last Update Posted : February 2, 2010
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Inositol may be effective in preventing the development of lung cancer in patients with bronchial epithelial dysplasia.

PURPOSE: This phase I trial is studying the side effects and best dose of inositol in preventing lung cancer in current or former smokers with bronchial epithelial dysplasia.

Condition or disease Intervention/treatment Phase
Lung Cancer Precancerous Condition Dietary Supplement: inositol Phase 1

Detailed Description:


  • Determine the safety of inositol for the prevention of lung cancer in patients with bronchial epithelial dysplasia who are current or former smokers.
  • Determine the potential efficacy of this drug in regression of existing dysplastic lesions or prevention of appearance of new dysplastic lesions in these patients.
  • Determine whether intake of this drug can facilitate smoking cessation in patients who are current smokers.

OUTLINE: This is a dose-escalation study.

Patients receive oral inositol twice daily. Treatment continues for 1 or 3 months in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-12 patients receive escalating doses of inositol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 12 patients experience dose-limiting toxicity.

Once the MTD is determined, 10 patients are treated with inositol twice daily at the MTD for 3 months in the absence of disease progression or unacceptable toxicity.

Patients are followed at 1 month.

PROJECTED ACCRUAL: A total of 3-28 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Prevention
Official Title: A Phase I Study Of The Safety Of Myo-Inositol As A Chemopreventive Agent
Study Start Date : May 2003

Resource links provided by the National Library of Medicine

Drug Information available for: Inositol

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   40 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Diagnosis of persistent bronchial dysplasia despite regular twice-daily treatment with inhaled budesonide for 6 or 12 months on protocol BCCA-CIC-98-37
  • Current or former smokers who have smoked at least 30 pack years
  • Sputum cells showing AIC atypia by computer-assisted image analysis
  • At least 2 abnormal sites on fluorescence bronchoscopy (red/green ratio at least 0.45) suspicious for bronchial dysplasia

    • At least 1 site confirmed by bronchial biopsy
    • Solitary dysplastic lesion allowed provided the diameter is greater than 1.5 mm
  • No invasive cancer on bronchoscopy or abnormal low-dose spiral CT scan suspicious for lung cancer



  • 40 to 74

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified


  • Hematologic function normal
  • No bleeding disorder


  • Liver function normal
  • Liver enzymes no greater than upper limit of normal


  • Renal function normal


  • No unstable angina
  • No congestive heart failure


  • No acute or chronic respiratory failure
  • No acute bronchitis or pneumonia within the past month


  • Fasting glucose less than 144 mg/dL
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Willing to have a bronchoscopy
  • No schizophrenia
  • No bipolar disorder
  • No diabetes
  • No known reaction to topical xylocaine
  • No other medical condition that would jeopardize patient safety during study participation


Biologic therapy

  • Not specified


  • No prior chemotherapy

Endocrine therapy

  • Not specified


  • No prior radiotherapy


  • No prior surgery for lung cancer


  • No concurrent lithium

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00061997

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Canada, British Columbia
British Columbia Cancer Agency - Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6
Sponsors and Collaborators
British Columbia Cancer Agency
National Cancer Institute (NCI)
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Study Chair: Stephen Lam, MD British Columbia Cancer Agency

Layout table for additonal information Identifier: NCT00061997    
Other Study ID Numbers: CDR0000302633
First Posted: June 6, 2003    Key Record Dates
Last Update Posted: February 2, 2010
Last Verified: November 2005
Keywords provided by National Cancer Institute (NCI):
non-small cell lung cancer
small cell lung cancer
precancerous condition
Additional relevant MeSH terms:
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Lung Neoplasms
Precancerous Conditions
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs