Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Cyproheptadine and Megestrol in Preventing Weight Loss in Children With Cachexia Caused By Cancer or Cancer Treatment

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Supportive care Completed 2 to 20 NCI MCC-0205 NCT00066248

Objectives

1. Determine the efficacy of cyproheptadine in preventing further weight loss in children with cancer or cancer treatment-related cachexia.
2. Determine the efficacy of megestrol in preventing further weight loss in patients who don't respond to cyproheptadine.
3. Determine how these drugs affect body protein and fat levels in these patients.

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%
  • 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)

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

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

Expected Enrollment

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

Outcomes

Efficacy of study agents as measured by changes in weight at baseline, and 4 weeks after the beginning of study treatment

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

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.

Trial Contact Information

Trial Lead Organizations

H. Lee Moffitt Cancer Center CCOP Research Base

Jennifer Mayer, MD, Protocol chair		Ph: 813-396-9529

Registry Information
Official Title		The Effect of Cyproheptadine Hydrochloride (Periactin) and Megestrol Acetate (Megace) on Weight in Children with Cancer/Treatment Related Cachexia
Trial Start Date		2003-06-30
Trial Completion Date		2007-12-10
Registered in ClinicalTrials.gov		NCT00066248
Date Submitted to PDQ		2003-05-22
Information Last Verified		2007-05-06

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