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Cyproheptadine and Megestrol in Preventing Weight Loss in Children With Cachexia Caused By Cancer or Cancer Treatment
This study has been completed.
Study NCT00066248   Information provided by National Cancer Institute (NCI)
First Received: August 6, 2003   Last Updated: May 9, 2009   History of Changes

August 6, 2003
May 9, 2009
June 2003
December 2007   (final data collection date for primary outcome measure)
Efficacy of study agents as measured by changes in weight at baseline, and 4 weeks after the beginning of study treatment
Same as current
Complete list of historical versions of study NCT00066248 on ClinicalTrials.gov Archive Site
Effect of study agents on protein and fat levels as measured by pre-albumin and lipid profile at baseline, and 4 weeks after the beginning of study treatment
Same as current
 
Cyproheptadine and Megestrol in Preventing Weight Loss in Children With Cachexia Caused By Cancer or Cancer Treatment
The Effect of Cyproheptadine Hydrochloride (Periactin) and Megestrol Acetate (Megace) on Weight in Children With Cancer/Treatment Related Cachexia

RATIONALE: Cyproheptadine and megestrol may improve appetite and help prevent weight loss in children with cancer.

PURPOSE: This phase II trial is studying how well cyproheptadine and megestrol work in improving appetite and preventing weight loss in children with cachexia caused by cancer or cancer treatment.

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 responding to either cyprohepatadine or megestrol may continue treatment at the discretion of the treating physician.

Patients are followed at 4 weeks.

PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study.

Phase II
Interventional
Supportive Care, Open Label
  • Brain and Central Nervous System Tumors
  • Cachexia
  • Leukemia
  • Lymphoma
  • Myelodysplastic Syndromes
  • Myelodysplastic/Myeloproliferative Diseases
  • Unspecified Childhood Solid Tumor, Protocol Specific
  • Drug: cyproheptadine hydrochloride
  • Drug: megestrol acetate
 
Couluris M, Mayer JL, Freyer DR, Sandler E, Xu P, Krischer JP. The effect of cyproheptadine hydrochloride (periactin) and megestrol acetate (megace) on weight in children with cancer/treatment-related cachexia. J Pediatr Hematol Oncol. 2008 Nov;30(11):791-7.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
70
 
December 2007   (final data collection date for primary outcome measure)

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%
    • 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 except intermittent steroid use (≤ 7 days in a 4 week period)

Radiotherapy

  • No more than 8 weeks since prior radiotherapy

Surgery

  • No more than 8 weeks since prior 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 more than 8 weeks since prior other anticancer therapy
  • 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
Both
2 Years to 20 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Puerto Rico
 
NCT00066248
 
CDR0000309056, MCC-0205
H. Lee Moffitt Cancer Center and Research Institute
National Cancer Institute (NCI)
Study Chair: Jennifer L. Mayer, MD H. Lee Moffitt Cancer Center and Research Institute
National Cancer Institute (NCI)
May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP