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Vitamin E in Preventing the Side Effects of Isotretinoin in Former and Current Smokers Who Are Receiving Isotretinoin to Prevent Lung Cancer

This study has been withdrawn prior to enrollment.
(Withdrawn study.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00003599
First Posted: September 13, 2004
Last Update Posted: February 22, 2012
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.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
  Purpose

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of isotretinoin may be an effective way to prevent lung cancer. Vitamin E may prevent the side effects of isotretinoin therapy.

PURPOSE: Randomized clinical trial to study the effectiveness of vitamin E in preventing the side effects of isotretinoin in former and current smokers who are receiving isotretinoin to prevent lung cancer.


Condition Intervention Phase
Lung Cancer Dietary Supplement: Vitamin E (AT) Drug: Isotretinoin Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Randomized Study of the Effect of Alpha-tocopherol (AT) on 13-cis-retinoic Acid (13-cRA) Toxicity in a Preliminary Chemoprevention Trial in Former and Current Smokers

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Effect of Alpha-tocopherol (AT) on 13-cis-retinoic Acid (13-cRA) Toxicity [ Time Frame: 6 Months ]

Enrollment: 0
Arms Assigned Interventions
Experimental: Arm I
Alpha-tocopherol (AT) orally and isotretinoin orally daily (arm I)
Dietary Supplement: Vitamin E (AT)
Orally daily
Other Names:
  • alpha-tocopherol
  • AT
Drug: Isotretinoin
Orally daily
Other Names:
  • Accutane
  • 13-cis-Retinoic acid
Experimental: Arm II
Isotretinoin orally plus AT placebo orally daily (arm II).
Drug: Isotretinoin
Orally daily
Other Names:
  • Accutane
  • 13-cis-Retinoic acid

Detailed Description:

OBJECTIVES: I. Determine whether the addition of alpha-tocopherol (AT; vitamin E) to isotretinoin decreases the incidence of Grade II and higher toxicity of isotretinoin when administered to former and current smokers. II. Determine the compliance rate of isotretinoin of smoker and former smokers with or without AT over a six month period. III. Determine the feasibility of recruiting former and current smokers with or without AT over a six month period. IV. Determine the effect of isotretinoin administration on serum retinol and retinol-binding protein levels in these patients.

OUTLINE: This is randomized, placebo controlled study. Patients are stratified by smoking status (current smoker vs former smoker) and age (less than 50 vs 50 and over). Patients are randomized to be take alpha-tocopherol (AT) orally and isotretinoin orally daily (arm I) or isotretinoin orally plus AT placebo orally daily (arm II). Treatment in each arm continues for 6 months. Patients are followed at 1, 3, 6, and 7 months from start of treatment.

PROJECTED ACCRUAL: There will be 300 patients (150 per arm) accrued into this study over an estimated 9 months.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Current smokers with 20+ packs per year history of smoking OR Former smokers who discontinued smoking 1 year prior to registration (less than 5 cigarettes in the prior year) and had a 20+ packs per year history prior to discontinuing smoking

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: WBC greater than 3,000/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL SGOT less than 40 IU/mL OR SGPT less than IU/mL Renal: Not specified Other: Fasting triglycerides less than 320 mg/dL No prior malignancy in the past 5 years except nonmelanoma skin cancer or noninvasive cervical cancer No history of malabsorption syndrome Not pregnant Effective contraception required of all fertile persons

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior isotretinoin Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: No prior warfarin or its derivatives At least 3 months since megadose vitamin A (greater than 25,000 IU/day) or beta-carotene greater than 30 mg/day or alpha-tocopherol at least 400 IU daily No concurrent megadose vitamin A (greater than 25,000 IU/day), beta-carotene greater than 30 mg/day, alpha-tocopherol at least 400 IU daily, or other daily supplements and tonics

  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00003599


Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
Study Chair: Rodger J. Winn, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00003599     History of Changes
Other Study ID Numbers: DM97-078
P30CA016672 ( U.S. NIH Grant/Contract )
MDA-DM-97078 ( Other Identifier: UT MD Anderson Cancer Center )
NCI-P98-0132
CDR0000066672 ( Registry Identifier: NCI PDQ )
First Submitted: November 1, 1999
First Posted: September 13, 2004
Last Update Posted: February 22, 2012
Last Verified: February 2012

Keywords provided by M.D. Anderson Cancer Center:
non-small cell lung cancer
small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Vitamins
Vitamin E
Tocopherols
Tocotrienols
alpha-Tocopherol
Tretinoin
Isotretinoin
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Antineoplastic Agents
Keratolytic Agents
Dermatologic Agents