Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Supportive care	Completed	Over 18	NCI	CCCWFU-97300 CCCWFU-0009, CCCWFU-BG00-228, NCI-P00-0174, NCT00006799

Objectives

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

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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

Wake Forest University Comprehensive Cancer Center

Kathryn Greven, MD, Protocol chair		Ph: 336-713-3600; 800-446-2255 Email: kgreven@wfubmc.edu

Registry Information
Official Title		A Phase III, Double-Blind, Randomized Study Of The Effect Of Megestrol Acetate On Weight And Health Related Quality Of Life In Head And Neck Cancer Patients Receiving Radiation Therapy
Trial Start Date		2000-10-30
Registered in ClinicalTrials.gov		NCT00006799
Date Submitted to PDQ		2000-10-12
Information Last Verified		2006-07-17
NCI Grant/Contract Number		CA12197