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Megestrol to Limit Weight Loss and Improve Quality of Life in Treating Patients With Head and Neck Cancer Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Megestrol to Limit Weight Loss and Improve Quality of Life in Treating Patients With Head and Neck Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Megestrol to Limit Weight Loss and Improve Quality of Life in Treating Patients With Head and Neck Cancer Clinical research trials and Megestrol to Limit Weight Loss and Improve Quality of Life in Treating Patients With Head and Neck Cancer medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Megestrol to Limit Weight Loss and Improve Quality of Life in Treating Patients With Head and Neck Cancer. Megestrol to Limit Weight Loss and Improve Quality of Life in Treating Patients With Head and Neck Cancer Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Megestrol to Limit Weight Loss and Improve Quality of Life in Treating Patients With Head and Neck Cancer clinical trial. Subjects typically recieve the finest healthcare available for their Megestrol to Limit Weight Loss and Improve Quality of Life in Treating Patients With Head and Neck Cancer condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "M" Clinical Trials Conditions > Megestrol to Limit Weight Loss and Improve Quality of Life in Treating Patients With Head and Neck Cancer  Megestrol to Limit Weight Loss and Improve Quality of Life in Treating Patients With Head and Neck Cancer
Megestrol to Limit Weight Loss and Improve Quality of Life in Treating Patients With Head and Neck Cancer
For Condition: lip and oral cavity cancer,Head and Neck Cancer,Oropharyngeal Cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Comprehensive Cancer Center of Wake Forest University
Synopsis: 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.
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.
Eligibility:
Study Type: Interventional, Educational/Counseling/Training
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
KathrynGreven, Study Chair, Comprehensive Cancer Center of Wake Forest University
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1082
United States
Additional Information:
Study ID Numbers: CDR0000068329; CCCWFU-97300,CCCWFU-BG00-228,CCCWFU-0009,NCI-P00-0174
Study Start Date: October 2000
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006799
Other Head And Neck Cancer Studies:
1. Isotretinoin, Interferon alfa, and Vitamin E in Treating Patients With Stage III or Stage IV Head and Neck Cancer
2. Radiation Therapy and Combination Chemotherapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer
3. Oxaliplatin in Treating Patients With Advanced Head and Neck Cancer
4. Surgery and Radiation Therapy Compared With Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer That Can Be Removed During Surgery
5. BMS-247550 Plus Cisplatin in Treating Patients With Metastatic or Recurrent Head and Neck Cancer
Related Studies:
Other Head and Neck Cancer Clinical Trials
Other North Carolina Clinical Trials
Other Winston Salem Clinical Trials
Megestrol to Limit Weight Loss and Improve Quality of Life in Treating Patients With Head and Neck Cancer
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