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

Information source: University of South Florida
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Brain Tumor; Central Nervous System Tumors; Cachexia; Leukemia; Lymphoma; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Diseases; Unspecified Childhood Solid Tumor, Protocol Specific

Intervention: cyproheptadine hydrochloride (Drug); megestrol acetate (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: University of South Florida

Official(s) and/or principal investigator(s):
Jennifer L. Mayer, MD, Study Chair, Affiliation: H. Lee Moffitt Cancer Center and Research Institute


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.

Clinical Details

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

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

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

Secondary outcome: 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

Detailed 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.


Minimum age: 2 Years. Maximum age: 20 Years. Gender(s): Both.



- 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


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


- 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.

Locations and Contacts

San Jorge Children's Hospital, Santurce 00912, Puerto Rico

CCOP - Bay Area Tumor Institute, Oakland, California 94609-3305, United States

Children's Hospital & Research Center Oakland, Oakland, California 94609, United States

Children's National Medical Center, Washington, District of Columbia 20010-2970, United States

University of Florida Shands Cancer Center, Gainesville, Florida 32610-0296, United States

Nemours Children's Clinic, Jacksonville, Florida 32207, United States

Sacred Heart Cancer Center at Sacred Heart Hospital, Pensacola, Florida 32504, United States

All Children's Hospital, St. Petersburg, Florida 33701, United States

CCOP - Florida Pediatric, Tampa, Florida 33682-7757, United States

St. Joseph's Children's Hospital of Tampa, Tampa, Florida 33677-4227, United States

Kaplan Cancer Center at St. Mary's Medical Center, West Palm Beach, Florida 33407, United States

MBCCOP - Medical College of Georgia Cancer Center, Augusta, Georgia 30912-4000, United States

Cancer Research Center of Hawaii, Honolulu, Hawaii 96813, United States

Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center, Kansas City, Kansas 66160-7357, United States

Children's Hospital of New Orleans, New Orleans, Louisiana 70118, United States

Floating Hospital for Children at Tufts - New England Medical Center, Boston, Massachusetts 02111, United States

Van Elslander Cancer Center at St. John Hospital and Medical Center, Detroit, Michigan 48236, United States

DeVos Children's Hospital, Grand Rapids, Michigan 49503, United States

CCOP - Beaumont, Royal Oak, Michigan 48073-6769, United States

University of Minnesota Cancer Center, Minneapolis, Minnesota 55455, United States

Children's Hospitals and Clinics of Minnesota - Minneapolis, Saint Paul, Minnesota 55106-2049, United States

Siteman Cancer Center at Barnes-Jewish Hospital, Saint Louis, Missouri 63110, United States

Tomorrows Children's Institute at Hackensack University Medical Center, Hackensack, New Jersey 07601, United States

Roswell Park Cancer Institute, Buffalo, New York 14263-0001, United States

SUNY Upstate Medical University Hospital, Syracuse, New York 13210, United States

Blumenthal Cancer Center at Carolinas Medical Center, Charlotte, North Carolina 28232-2861, United States

Wake Forest University Comprehensive Cancer Center, Winston-Salem, North Carolina 27157-1096, United States

Children's Hospital Medical Center of Akron, Akron, Ohio 44308-1062, United States

Columbus Children's Hospital, Columbus, Ohio 43205-2696, United States

Children's Medical Center - Dayton, Dayton, Ohio 45404-1815, United States

Tod Children's Hospital, Youngstown, Ohio 44501, United States

Legacy Emanuel Hospital and Health Center & Children's Hospital, Portland, Oregon 97227, United States

Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania 15213, United States

Hopital Sainte Justine, Montreal, Quebec H3T 1C5, Canada

Montreal Children's Hospital at McGill University Health Center, Montreal, Quebec H3G 1A4, Canada

CHRISTUS Santa Rosa Children's Hospital, San Antonio, Texas 78207, United States

MBCCOP - South Texas Pediatrics, San Antonio, Texas 78229-3900, United States

Methodist Cancer Center at Methodist Specialty and Transplant Hospital, San Antonio, Texas 78229-3902, United States

CCOP - Scott and White Hospital, Temple, Texas 76508, United States

Vermont Cancer Center at University of Vermont, Burlington, Vermont 05405-0110, United States

Virginia Commonwealth University Massey Cancer Center, Richmond, Virginia 23298-0121, United States

Children's Hospital and Regional Medical Center - Seattle, Seattle, Washington 98105-3916, United States

St. Vincent Hospital Regional Cancer Center, Green Bay, Wisconsin 54307-9070, United States

Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: June 2003
Last updated: January 31, 2014

Page last updated: August 23, 2015

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