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Home > "C" Clinical Trials Conditions > Cyproheptadine and Megestrol in Preventing Weight Loss in Children With Cachexia Caused By Cancer or Cancer Treatment  Cyproheptadine and Megestrol in Preventing Weight Loss in Children With Cachexia Caused By Cancer or Cancer Treatment
Cyproheptadine and Megestrol in Preventing Weight Loss in Children With Cachexia Caused By Cancer or Cancer Treatment
For Condition: childhood brain tumor,hematopoietic and lymphoid cancer,Cachexia,childhood solid tumor,childhood non-Hodgkin's lymphoma,childhood Hodgkin's lymphoma
Status: Recruiting
Sponsor(s): H. Lee Moffitt Cancer Center and Research Institute , National Cancer Institute (NCI)
Synopsis: RATIONALE: Cyproheptadine and megestrol may improve appetite and help prevent weight loss in children with cancer. PURPOSE: Clinical trial to study the effectiveness of cyproheptadine and megestrol in improving appetite and preventing weight loss in children who have cachexia caused by cancer or cancer treatment.
Details: OBJECTIVES: - Determine the efficacy of cyproheptadine in preventing further weight loss in children with cancer or cancer treatment-related cachexia. - Determine the efficacy of megestrol in preventing further weight loss in patients who don't respond to cyproheptadine. - Determine how these drugs affect body protein and fat levels in these patients. OUTLINE: Patients receive oral cyproheptadine twice daily for 4 weeks in the absence of unacceptable weight loss or toxicity. Patients that present with weight loss after 4 weeks receive oral megestrol daily for 4 weeks in the absence of unacceptable weight loss or toxicity. Patients are followed at 4 weeks. PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 2 Years/20 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Newly diagnosed or relapsed cancer of any type, including brain tumors - Cachexia with weight loss presumed secondary to cancer or cancer-related treatment defined as 1 or more of the following: - Documented weight loss of at least 5% within 1 month of study entry - Drop in growth rate 2 or more percentile ranks on standard growth charts - Weight for height less than the tenth percentile - No hormone-sensitive tumors (i.e., meningiomas, breast cancer, ovarian cancer, or endometrial cancer) PATIENT CHARACTERISTICS: Age - 2 to 20 Performance status - Not specified Life expectancy - At least 8 weeks Hematopoietic - Not specified Hepatic - Not specified Renal - Not specified Cardiovascular - No thromboembolic disease - No congestive heart failure - No recurrent or persistent hypertension (i.e., blood pressure values greater than 20% above normal) Other - Not pregnant or nursing - Fertile patients must use effective contraception - No type I or II neurofibromatosis - No glaucoma - No chronic persistent asthma - No gastrointestinal or genitourinary obstruction - No peripheral edema PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No more than 8 weeks since prior chemotherapy Endocrine therapy - No concurrent corticosteroids Radiotherapy - No more than 8 weeks since prior radiotherapy Surgery - Concurrent tumor-debulking surgery, limb-sparing surgery, or amputation allowed Other - More than 3 weeks since prior cyproheptadine or megestrol - More than 3 weeks since prior dronabinol or other appetite-stimulating medications - More than 1 week since prior parenteral nutrition or tube feedings - No other concurrent appetite-stimulating medications - No concurrent parenteral nutrition or tube feedings - No concurrent monoamine oxidase inhibitors (e.g., moclobemide, phenelzine, or tranylcypromine) - Concurrent active or palliative therapy allowed
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JenniferR Mayer, Study Chair, H. Lee Moffitt Cancer Center and Research Institute
Nemours Children's Clinic *Recruiting*
Jacksonville, Florida, 32207
United States
Recruiting Eric Sandler 904-390-3793
MBCCOP - South Texas Pediatrics *Recruiting*
San Antonio, Texas, 78229-3900
United States
Recruiting Anthony Infante 210-567-5265
CCOP - Florida Pediatric *Recruiting*
Tampa, Florida, 33682-7757
United States
Recruiting James Talbert 352-392-3718
CCOP - Scott and White Hospital *Recruiting*
Temple, Texas, 76508
United States
Recruiting Lucas Wong 254-724-7048
Shands Cancer Center at the University of Florida Health Science Center *Recruiting*
Gainesville, Florida, 32610-0296
United States
Recruiting Stephen Hunger 352-392-9393
Additional Information:
Study ID Numbers: CDR0000309056; MCC-0205
Study Start Date:
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00066248
Other Cachexia Studies:
1. Creatine in Treating Patients With Cancer-Associated Weight Loss
2. Comparison of Megestrol and/or Omega-3 Fatty Acid-Enriched Nutritional Supplement in Treating Patients With Cancer-Related Weight Loss and Lack of Appetite
3. Phase II Randomized Study of Physiologic Testosterone Replacement in Premenopausal, HIV-Positive Women
4. Phase III Randomized Double-Blind Study Comparing Megestrol Acetate at 800 mg/day, and Placebo in AIDS Patients With Anorexia and Cachexia
5. Comparison of Nutritional Supplements in Preventing Weight Loss in Patients With Cancer
Related Studies:
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Cyproheptadine and Megestrol in Preventing Weight Loss in Children With Cachexia Caused By Cancer or Cancer Treatment
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