Megestrol to Limit Weight Loss and Improve Quality of Life in Treating Patients With Head and Nec… (NCT00006799) | Clinical Trial Compass
CompletedPhase 3
Megestrol to Limit Weight Loss and Improve Quality of Life in Treating Patients With Head and Neck Cancer
United States13 participantsStarted 2000-10-01
Plain-language 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.
Who can participate
Age range18 Years – 120 Years
SexALL
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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 cor…