Megestrol to Limit Weight Loss and Improve Quality of Life in Treating Patients With Head and Neck Cancer

• Status: Completed
• Trial end date: 2002-09-06
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Megestrol helps improve appetite. It is not yet known if megestrol is effective in limiting weight loss caused by cancer.

PURPOSE: Randomized phase III trial to determine the effectiveness of megestrol in limiting weight loss and improving quality of life in patients who have head and neck cancer and are undergoing radiation therapy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wake Forest Baptist Health; Wake Forest University Health Sciences
• Collaborator: National Cancer Institute (NCI)
• Treatments: Megestrol; Megestrol Acetate

Criteria

DISEASE CHARACTERISTICS:

• Histologically proven resected or unresectable stage I-IV epithelial head and neck cancer

• Must be scheduled to receive a total dose of radiotherapy of at least 5,000 cGy in fraction sizes of no greater than 200 cGy

• No distant metastases

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 history of congestive heart failure or thromboembolic events

• No uncontrolled hypertension, active thromboembolic disease, or myocardial infarction within the past 3 months

Pulmonary:

• No history of pulmonary edema

Other:

• No other malignancy within the past 3 years except curatively treated carcinoma in situ of the cervix or nonmelanoma skin cancer

• No feeding tube

• No preexisting or uncontrolled diabetes with glycosylated hemoglobin greater than 10%

• No history of Cushing's syndrome

• No dietary restriction (salt, sugar, or lipid)

• No serious medical or psychiatric illness that would preclude study

• No significant ascites, pleural effusions, or edema that may inhibit oral food intake or invalidate weight measurements

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• Prior chemotherapy allowed

Endocrine therapy:

• At least 1 year since prior corticosteroids, estrogens, progestins, or any other steroid hormone

• No concurrent estrogens or other progestins

• Concurrent glucocorticoid replacement (10 mg of prednisone a day) allowed only if patient experiences moderate "stress" (e.g., infection, trauma, or fluid loss sufficient to require hospitalization and/or IV fluid replacement)

Radiotherapy:

• See Disease Characteristics

• No prior radiotherapy to the head and neck

Surgery:

• Not specified