Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

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Substance Related Disorders

Rare Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Small Cell Lung Carcinoma

Drug-Related Side Effects and Adverse Reactions

Respiratory Tract Neoplasms

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Lung Diseases

Respiratory Tract Diseases

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Micronutrients

All Drugs and Chemicals

Dermatologic Agents

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Vitamins

Tocopherols

Vitamin E

Tocotrienols

alpha-Tocopherol

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Tretinoin

Trace Elements

Antioxidants

Protective Agents

Keratolytic Agents

Tocopherol

Tocotrienol

13-Cis Retinoic Acid (50 mg/day) Tocopherol (800 mg/day)

13-cis retinoic acid

York E. Miller, MD

RATIONALE: 13 Cis retinoic acid may prevent the development of cancer cells.

PURPOSE: Randomized double-blinded phase II trial to study the effectiveness of 13-cis retinoic acid with or without vitamin E for chemoprevention or observation of cancer in persons at high risk of developing lung cancer.

OBJECTIVES:

* To determine if alpha tocopherol can reduce the toxicities of low dose 13-cis retinoic acid administered for one year.
* To access the adequacy of the collected specimens for studies of intermediate endpoint markers.
* to establish a depository of biologic specimens for future studies of new biomarkers.

  * Arm 1: Patients receive oral 13-cis retinoic acid daily.
  * Arm 2: Patients receive oral 13-cis retinoic acid and oral vitamin E daily.
  * Arm 3: Patients undergo observation only. Treatment continues in arms I and II for 1 year in the absence of unacceptable toxicity.

Patients are followed annually for 2 years.

PROJECTED ACCRUAL: A total of 100 patients (33 Arm 1, 33 Arm 2, and 34 Arm 3) will be accrued for this study within 3 years.

13-Cis Retinoic Acid With or Without Vitamin E for Prevention of Lung Cancer

ASSESSMENT OF INTERMEDIATE ENDPOINT BIOMARKERS TO 13-CIS RETINOIC ACID WITH OR WITHOUT ALPHA TOCOPHEROL OR OBSERVATION

Treatment "failure" defined as histologic progression (any increase in the maximum histologic score) or failure to return for follow-up bronchoscopy

University of Colorado, Denver

Mouth and Tooth Diseases

Digestive System Diseases

Stomatitis

Mucositis

Gastroenteritis

Gastrointestinal Diseases

Mouth Diseases

Stomatognathic Diseases

Shimon Slavin, MD

The present protocol is an attempt to prevent/treat mucositis in highly susceptible patients subjected to maximally tolerated doses of subsequently-myeloablative or myeloablative doses of chemoradiotherapy supported by autologous or allogeneic stem cell transplantation at the Department of Bone Marrow Transplantation. Mucositis is a major problem in the management of transplant recipients which subjects the patients to the risk of sepsis, need for parenteral nutrition and need of narcotics. We are planning a 2 arm study, comparing 2 safe vitamin E based formulations with placebo.

Tocopherol is a Novel Treatment for Cancer Related Mucositis

A Randomized Double Blind Placebo Controlled Clinical Trial Aim to Assess the Efficacy of Vitamin E Formulation (Tocopherol) in the Treatment of Chemotherapy Induced Stomatitis in Patients Undergoing Stem Cell Transplantation

Hadassah Medical Organization

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
13-Cis Retinoic Acid With or Without Vitamin E for Prevention of Lung Cancer	NCT00002586	Drug Toxicity Lung Cancer	13-cis retinoic... Tocopherol	18 Years - 90 Years	University of Colorado, Denver
13-Cis Retinoic Acid With or Without Vitamin E for Prevention of Lung Cancer	NCT00002586	Drug Toxicity Lung Cancer	13-cis retinoic... Tocopherol	18 Years - 90 Years	University of Colorado, Denver
Tocopherol is a Novel Treatment for Cancer Related Mucositis	NCT00162526	Oral Mucositis	Tocopherol	18 Years -	Hadassah Medical Organization

Spots Global Cancer Trial Database for tocopherol

Every month we try and update this database with for tocopherol cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for tocopherol

Every month we try and update this database with for tocopherol cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for tocopherol cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.