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Phase III Randomized Study of the Effect of Megestrol on Weight and Quality of Life in Patients With Head and Neck Cancer
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 | Protocol IDs |
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Phase III | Supportive care | Completed | Over 18 | CCCWFU-97300 CCCWFU-0009, CCCWFU-BG00-228, NCI-P00-0174, NCT00006799 |
Objectives - Determine the effect of megestrol on the weight of patients with head and neck cancer who are undergoing localized radiotherapy.
- 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: 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: Patient Characteristics:
Age: Performance status: Life expectancy: Hematopoietic: Hepatic: Renal: 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 | | | |
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 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
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