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Sponsors and Collaborators: |
Wake Forest University National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00031785 |
RATIONALE: Megestrol helps improve appetite. It is not yet known if megestrol is effective in limiting weight loss in patients who are undergoing radiation therapy.
PURPOSE: Randomized phase III trial to determine the effectiveness of megestrol in limiting weight loss in patients who are undergoing radiation therapy for lung cancer.
Condition | Intervention | Phase |
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Cancer-Related Problem/Condition Lung Cancer |
Drug: megestrol acetate Procedure: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Supportive Care |
Official Title: | A Phase III, Double-Blind, Randomized Study of the Effect of Megestrol Acetate on Weight and Health Related Quality of Life in Lung Cancer Patients Receiving Thoracic Radiation Therapy |
Study Start Date: | September 2000 |
OBJECTIVES:
OUTLINE: This is a randomized, placebo-controlled, double-blind, multicenter study. Patients are stratified according to histology (non-small cell lung cancer vs small cell lung cancer), and type of treatment (radiotherapy vs radiotherapy and non-cisplatin-containing chemotherapy vs radiotherapy and cisplatin-containing chemotherapy). Patients are randomized to one of two treatment arms.
All patients undergo thoracic radiotherapy beginning on week 1 and continuing for a total of 5-7 weeks.
In both arms, quality of life is assessed at baseline, at the completion of radiotherapy, and at 4, 8, 12, 16, and 20 weeks after the completion of radiotherapy.
Patients are followed at 4 and 8 weeks.
PROJECTED ACCRUAL: A total of 98 patients (49 per treatment arm) will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed lung cancer
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United States, North Carolina | |
Comprehensive Cancer Center at Wake Forest University | |
Winston-Salem, North Carolina, United States, 27157-1082 |
Study Chair: | Edward G. Shaw, MD | Wake Forest University |
Study ID Numbers: | CDR0000069226, CCCWFU-98199, NCI-P02-0210 |
Study First Received: | March 8, 2002 |
Last Updated: | October 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00031785 |
Health Authority: | United States: Federal Government |
stage I non-small cell lung cancer stage II non-small cell lung cancer limited stage small cell lung cancer stage IIIA non-small cell lung cancer |
stage IIIB non-small cell lung cancer anorexia cachexia |
Thoracic Neoplasms Non-small cell lung cancer Cachexia Quality of Life Megestrol Carcinoma, Small Cell Body Weight |
Respiratory Tract Diseases Lung Neoplasms Lung Diseases Anorexia Carcinoma, Non-Small-Cell Lung Megestrol Acetate |
Respiratory Tract Neoplasms Antineoplastic Agents, Hormonal Contraceptive Agents Antineoplastic Agents Physiological Effects of Drugs Contraceptives, Oral Contraceptive Agents, Female Central Nervous System Stimulants |
Reproductive Control Agents Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Contraceptives, Oral, Synthetic Central Nervous System Agents Appetite Stimulants |