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Oxandrolone Compared With Megestrol in Preventing Weight Loss in Patients Receiving Chemotherapy for Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Oxandrolone Compared With Megestrol in Preventing Weight Loss in Patients Receiving Chemotherapy for Cancer conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Oxandrolone Compared With Megestrol in Preventing Weight Loss in Patients Receiving Chemotherapy for Cancer Clinical research trials and Oxandrolone Compared With Megestrol in Preventing Weight Loss in Patients Receiving Chemotherapy for Cancer healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Oxandrolone Compared With Megestrol in Preventing Weight Loss in Patients Receiving Chemotherapy for Cancer. Oxandrolone Compared With Megestrol in Preventing Weight Loss in Patients Receiving Chemotherapy for Cancer Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Oxandrolone Compared With Megestrol in Preventing Weight Loss in Patients Receiving Chemotherapy for Cancer clinical trial. Test subjects typically receive the most effective healthcare possible for their Oxandrolone Compared With Megestrol in Preventing Weight Loss in Patients Receiving Chemotherapy for Cancer condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "O" Clinical Trials Conditions > Oxandrolone Compared With Megestrol in Preventing Weight Loss in Patients Receiving Chemotherapy for Cancer  Oxandrolone Compared With Megestrol in Preventing Weight Loss in Patients Receiving Chemotherapy for Cancer
Oxandrolone Compared With Megestrol in Preventing Weight Loss in Patients Receiving Chemotherapy for Cancer
For Condition: weight changes,unspecified adult solid tumor, protocol specific,Quality of Life
Status: Recruiting
Sponsor(s): Comprehensive Cancer Center of Wake Forest University , National Cancer Institute (NCI)
Synopsis: RATIONALE: Oxandrolone and megestrol may help prevent weight loss and improve quality of life in patients with cancer. It is not yet known whether oxandrolone is more effective than megestrol in preventing weight loss and improving quality of life in patients who are receiving chemotherapy for solid tumors. PURPOSE: Randomizedphase III trial to compare the effectiveness of oxandrolone with that of megestrol in preventing weight loss and improving quality of life in patients who are receiving chemotherapy for solid tumors.
Details: OBJECTIVES: - Compare the lean body mass and weight of patients with solid tumors and weight loss who are receiving chemotherapy when treated with oxandrolone vs megestrol. - Compare the health-related quality of life of patients treated with these drugs. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease stage (I-III vs IV), concurrent radiotherapy (yes vs no), and gender. Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive oral oxandrolone twice daily. - Arm II: Patients receive oral megestrol once daily. In both arms, treatment continues for 12 weeks in the absence of excessive weight loss or gain or unacceptable toxicity. Quality of life, weight, and body composition are assessed at baseline, at 1, 2, and 3 months during study therapy, and then at 1 month after study completion. Patients are followed at 1 month. PROJECTED ACCRUAL: A total of 62-155 patients (31-77 per treatment arm) will be accrued for this study within 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed solid tumor, excluding any of the following: - Breast cancer - Ovarian cancer - Prostate cancer - Hormonally responsive germ cell tumors - Primary or metastatic malignant brain tumors - Leukemia - Lymphoma - Myeloma - Other hematologic malignancies - Currently receiving chemotherapy - Weight loss meeting criteria for 1 of the following: - At least 5% total body weight loss within the past 6 months - At least 3% weight loss within the past month - Progressive weight loss on 2 consecutive visits despite dietary, behavioral, or pharmacologic intervention - Body Mass Index no greater than 35 - No significant ascites, pleural effusion, or edema that would preclude oral food intake or invalidate weight determinations PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - At least 6 months Hematopoietic - Not specified Hepatic - SGOT and SGPT no greater than 2 times upper limit of normal - Bilirubin no greater than 2.5 mg/dL Renal - Creatinine no greater than 2.5 mg/dL - No hypercalcemia - No nephrosis or nephrotic phase of nephritis Cardiovascular - No uncontrolled hypertension - No congestive heart failure - No unstable angina - No myocardial infarction within the past 3 months - No active thromboembolic disease within the past 6 months Pulmonary - No pulmonary edema Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No other pre-existing or uncontrolled medical condition that would preclude study participation or giving informed consent - No psychological illness that would preclude study participation or giving informed consent - No Cushing's syndrome - No uncontrolled diabetes (i.e., HbA1C greater than 10%) - Prostate-specific antigen no greater than 4 ng/mL (men age 40 and over) - Able to swallow 8 small tablets or 20 cc of liquid daily - Able to meet nutritional requirements orally (with food or supplements) or enteral tube feedings PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - See Disease Characteristics Endocrine therapy - More than 3 months since prior oxandrolone or megestrol - No concurrent corticosteroids - Concurrent intermittent corticosteroids as part of a pre-chemotherapy antiemetic regimen are allowed - No concurrent estrogens - No other concurrent progestins (including megestrol) - No other concurrent steroid hormone Radiotherapy - Not specified Surgery - Not specified Other - No concurrent oral anticoagulants (e.g., warfarin) for systemic anticoagulation - Concurrent warfarin for maintenance of central venous catheter patency allowed provided INR is no greater than 1.2 - No concurrent oral hypoglycemic agents
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GlennLesser, , Comprehensive Cancer Center of Wake Forest University
Comprehensive Cancer Center at Wake Forest University *Recruiting*
Winston Salem, North Carolina, 27157-1030
United States
Recruiting Edward Shaw 336-716-4647
Additional Information:
Study ID Numbers: CDR0000330073; CCCWFU-0103,CCCWFU-97102
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00070148
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Oxandrolone Compared With Megestrol in Preventing Weight Loss in Patients Receiving Chemotherapy for Cancer
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