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This study has been withdrawn prior to enrollment.
(Withdrawn study.)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:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00003599
First received: November 1, 1999
Last updated: February 17, 2012
Last verified: February 2012
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003599

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

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00003599     History of Changes
Other Study ID Numbers: DM97-078, P30CA016672, MDA-DM-97078, NCI-P98-0132, CDR0000066672
Study First Received: November 1, 1999
Last Updated: February 17, 2012
Health Authority: United States: Institutional Review Board

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
Alpha-Tocopherol
Tocopherols
Tocotrienols
Isotretinoin
Tretinoin
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Dermatologic Agents
Therapeutic Uses
Antineoplastic Agents
Keratolytic Agents

ClinicalTrials.gov processed this record on September 18, 2014