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.

Condition	Treatment or Intervention	Phase
lip and oral cavity cancer Head and Neck Cancer Oropharyngeal Cancer	Procedure: supportive care  Drug: nutritional support  Procedure: complications of therapy assessment/management  Procedure: anticachectic therapy  Behavior: supportive care/therapy  Procedure: quality-of-life assessment  Drug: megestrol	Phase III

Further Study Details: 

OBJECTIVES: I. Determine the effect of megestrol on the weight of patients with head and neck cancer who are undergoing localized radiotherapy. II. Determine whether health-related quality of life improves in patients treated with megestrol.

PROTOCOL OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to type of treatment (radiotherapy alone vs radiotherapy plus platinum-based chemotherapy vs radiotherapy plus non-platinum-based chemotherapy) and type of radiotherapy (primary vs postoperative). Patients are randomized to one of two treatment arms. Arm I: Patients receive oral megestrol daily beginning within the first three days of radiotherapy and continuing during 5-7 weeks of radiotherapy and for 12 weeks after completion of radiotherapy. Arm II: Patients receive oral placebo daily according to the schedule for megestrol in arm I. Quality of life is assessed at baseline, at completion of radiotherapy, and then at 4, 8, 12, and 16 weeks after completion of radiotherapy.

PROJECTED ACCRUAL: A total of 48-144 patients (24-72 per arm) will be accrued for this study within 14 months.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY 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

--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

--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

North Carolina
      Comprehensive Cancer Center at Wake Forest University, Winston Salem,  North Carolina,  27157-1082,  United States

Study chairs or principal investigators

Kathryn McConnell Greven,  Study Chair,  Comprehensive Cancer Center of Wake Forest University   

Study ID Numbers:  CDR0000068329; CCCWFU-97300; NCI-P00-0174; CCCWFU-0009; CCCWFU-BG00-228
Record last reviewed:  July 2003
Last Updated:  October 13, 2004
Record first received:  December 6, 2000
ClinicalTrials.gov Identifier:  NCT00006799
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08