Lung Cancer Clinical Trial
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
Verified date | September 2021 |
Source | Wake Forest University Health Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 25 |
Est. completion date | September 11, 2002 |
Est. primary completion date | September 11, 2002 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 120 Years |
Eligibility | DISEASE CHARACTERISTICS: - Histologically confirmed lung cancer - Unresectable stage I-IIIB non-small cell lung cancer (NSCLC) - Resected stage I-IIIB NSCLC - Limited stage small cell lung cancer - Planned radiotherapy with a total dose of at least 5,000 cGy in fraction sizes of no greater than 200 cGy each - No distant metastases - No significant ascites, pleural effusions, or edema that would inhibit oral food intake or invalidate weight determinations PATIENT CHARACTERISTICS: Age: - Over 18 Performance status: - ECOG 0-2 Life expectancy: - More than 3 months Hematopoietic: - Not specified Hepatic: - Not specified Renal: - Not specified Cardiovascular: - No uncontrolled hypertension - No active thromboembolic disease - No myocardial infarction within the past 3 months - No prior congestive heart failure or thromboembolic events Pulmonary: - No prior pulmonary edema Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No other malignancy within the past 3 years except curatively treated carcinoma in situ of the cervix or non-melanoma skin cancer - No uncontrolled diabetes with glycosylated hemoglobin greater than 10% - No Cushing's syndrome - No dietary restrictions (e.g., salt, sugar, or lipid) - No other serious medical or psychiatric illness that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - See Endocrine therapy Endocrine therapy: - At least 12 months since prior corticosteroids, estrogens, progestins, or other steroid hormone except as antiemetic prior to chemotherapy - No concurrent corticosteroids, estrogens, progestins, or other steroid hormone except as antiemetic prior to chemotherapy Radiotherapy: - See Disease Characteristics - No prior radiotherapy to lung Surgery: - See Disease Characteristics - More than 14 days since prior surgery |
Country | Name | City | State |
---|---|---|---|
United States | Comprehensive Cancer Center at Wake Forest University | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Wake Forest University Health Sciences | National Cancer Institute (NCI) |
United States,
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