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

Lymphoma Clinical Trial

Official title:

The Effect of Cyproheptadine Hydrochloride (Periactin) and Megestrol Acetate (Megace) on Weight in Children With Cancer/Treatment Related Cachexia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00066248
• Other study ID #: SCUSF 0205
• Secondary ID: HLMCC-0205U10CA0
• Status: Completed
• Phase: Phase 2
• First received: August 6, 2003
• Last updated: January 31, 2014
• Start date: June 2003
• Est. completion date: August 2007

Study information

• Verified date: January 2014
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Data and Safety Monitoring BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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 cyproheptadine 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 20 Years

Eligibility

INCLUSION CRITERIA:

• Any cachectic patient with weight loss presumed secondary to cancer or cancer related therapy is eligible. Cachexia is defined as having one or more of the following:

• documented history of weight loss > 5%

• drop in growth rate two or more percentile ranks on standard growth charts,

• weight for height less than the tenth percentile.

• Patients with newly diagnosed or relapsed cancer of any type, including brain tumors.

• Patients who are receiving active or palliative therapy are eligible.

• If patients have completed treatment for cancer (surgery, chemotherapy, radiotherapy) within 8 weeks of study registration, they are also eligible.

• Patients must be = 2 years and < 21 years of age at the time of admission to this study.

• Patients must have a predicted life expectancy of at least eight weeks.

EXCLUSION CRITERIA:

• Patients who are currently taking or who have taken Periactin and/or Megace during the past three weeks are not eligible.

• Patients receiving corticosteroid or monoamine oxidase (MAO) inhibitor therapy. (Intermittent steroid use is permitted IF you anticipate it will not be administered for more than 7 days in a 4 week period. Calculate anticipated intermittent steroid use in 4-week intervals through the 8-week period during which study agent may be administered (4 weeks for Periactin and potentially 4 weeks for Megace.

• Patients who have received parenteral nutrition or tube feedings within 1 week of starting this protocol or patients who are expected to require parenteral nutrition or tube feedings during the 4-week course of this study.

• Patients taking dronabinol (Marinol) or other appetite-stimulating medications during the past three weeks or patients expected to be prescribed appetite-stimulating medications during the 4-week course of this study.

• Patients with hormone sensitive tumors specifically meningiomas, breast cancer, ovarian cancer, and endometrial carcinoma.31, 32

• Children with neurofibromatosis, type I or II, are at risk for the development of meningiomas and are thus excluded from this study.32

• Children with glaucoma, chronic persistent asthma, or gastrointestinal (GI) or genitourinary (GU) obstruction.

• Patients with recurrent and/or persistent hypertension, defined as blood pressure values >20% above normal.

• Patients with thromboembolic disease, congestive heart failure, or peripheral edema.

• Patients who are pregnant.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumor
• Cachexia
• Central Nervous System Neoplasms
• Central Nervous System Tumors
• Leukemia
• Lymphoma
• Myelodysplastic Syndromes
• Myelodysplastic-Myeloproliferative Diseases
• Myelodysplastic/Myeloproliferative Diseases
• Myeloproliferative Disorders
• Nervous System Neoplasms
• Preleukemia
• Unspecified Childhood Solid Tumor, Protocol Specific

Intervention

Drug:
• cyproheptadine hydrochloride
Receive 0.25mg/kg cyproheptadine hydrochloride once daily for 4 weeks. If subject responds to treatment (stable or increased weigh), go off study. If subject does not respond (loses weigh), subject will switch to10 mg/lg/day of megestrol acetate for 4 weeks.
• megestrol acetate
Receive 0.25mg/kg cyproheptadine hydrochloride once daily for 4 weeks. If subject responds to treatment (stable or increased weigh), go off study. If subject does not respond (loses weigh), subject will switch to10 mg/lg/day of megestrol acetate for 4 weeks.

Locations

Country	Name	City	State
Canada	Hopital Sainte Justine	Montreal	Quebec
Canada	Montreal Children's Hospital at McGill University Health Center	Montreal	Quebec
Puerto Rico	San Jorge Children's Hospital	Santurce
United States	Children's Hospital Medical Center of Akron	Akron	Ohio
United States	MBCCOP - Medical College of Georgia Cancer Center	Augusta	Georgia
United States	Floating Hospital for Children at Tufts - New England Medical Center	Boston	Massachusetts
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Vermont Cancer Center at University of Vermont	Burlington	Vermont
United States	Blumenthal Cancer Center at Carolinas Medical Center	Charlotte	North Carolina
United States	Columbus Children's Hospital	Columbus	Ohio
United States	Children's Medical Center - Dayton	Dayton	Ohio
United States	Van Elslander Cancer Center at St. John Hospital and Medical Center	Detroit	Michigan
United States	University of Florida Shands Cancer Center	Gainesville	Florida
United States	DeVos Children's Hospital	Grand Rapids	Michigan
United States	St. Vincent Hospital Regional Cancer Center	Green Bay	Wisconsin
United States	Tomorrows Children's Institute at Hackensack University Medical Center	Hackensack	New Jersey
United States	Cancer Research Center of Hawaii	Honolulu	Hawaii
United States	Nemours Children's Clinic	Jacksonville	Florida
United States	Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center	Kansas City	Kansas
United States	University of Minnesota Cancer Center	Minneapolis	Minnesota
United States	Children's Hospital of New Orleans	New Orleans	Louisiana
United States	CCOP - Bay Area Tumor Institute	Oakland	California
United States	Children's Hospital & Research Center Oakland	Oakland	California
United States	Sacred Heart Cancer Center at Sacred Heart Hospital	Pensacola	Florida
United States	Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania
United States	Legacy Emanuel Hospital and Health Center & Children's Hospital	Portland	Oregon
United States	Virginia Commonwealth University Massey Cancer Center	Richmond	Virginia
United States	CCOP - Beaumont	Royal Oak	Michigan
United States	Siteman Cancer Center at Barnes-Jewish Hospital	Saint Louis	Missouri
United States	Children's Hospitals and Clinics of Minnesota - Minneapolis	Saint Paul	Minnesota
United States	CHRISTUS Santa Rosa Children's Hospital	San Antonio	Texas
United States	MBCCOP - South Texas Pediatrics	San Antonio	Texas
United States	Methodist Cancer Center at Methodist Specialty and Transplant Hospital	San Antonio	Texas
United States	Children's Hospital and Regional Medical Center - Seattle	Seattle	Washington
United States	All Children's Hospital	St. Petersburg	Florida
United States	SUNY Upstate Medical University Hospital	Syracuse	New York
United States	CCOP - Florida Pediatric	Tampa	Florida
United States	St. Joseph's Children's Hospital of Tampa	Tampa	Florida
United States	CCOP - Scott and White Hospital	Temple	Texas
United States	Children's National Medical Center	Washington	District of Columbia
United States	Kaplan Cancer Center at St. Mary's Medical Center	West Palm Beach	Florida
United States	Wake Forest University Comprehensive Cancer Center	Winston-Salem	North Carolina
United States	Tod Children's Hospital	Youngstown	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University of South Florida	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada,  Puerto Rico, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of study agents as measured by changes in weight at baseline, and 4 weeks after the beginning of study treatment		4-8 weeks	No
Secondary	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		4-8 weeks	No