Cyproheptadine in Preventing Weight Loss in Children Receiving Chemotherapy for Cancer



Status:Recruiting
Conditions:Cancer, Obesity Weight Loss, Other Indications
Therapuetic Areas:Endocrinology, Oncology, Other
Healthy:No
Age Range:2 - 21
Updated:10/19/2013
Start Date:June 2010
Contact:Nina Naas, MPH, CPH
Email:Nina.Naas@epi.usf.edu
Phone:813-396-9502

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Prevention of Cancer/Treatment-Related Weight Loss in Children at High Nutritional Risk


RATIONALE: Cyproheptadine hydrochloride may prevent weight loss caused by cancer or cancer
treatment. It is not yet known whether cyproheptadine is more effective than a placebo in
preventing weight loss in young patients receiving chemotherapy for cancer.

PURPOSE: This randomized phase III trial is studying cyproheptadine hydrochloride to see how
well it works in preventing weight loss in young patients receiving chemotherapy for cancer.


OBJECTIVES:

Primary

- To determine the effect of cyproheptadine hydrochloride in the prevention of cancer- or
treatment-related weight loss (defined as ≥ 5% reduction in weight from baseline
measurement) in children who are initiating a course of moderately or highly emetic
chemotherapy.

Secondary

- To investigate the effect of cyproheptadine HCl on the change in weight for age scores
after 8 weeks of study drug administration in comparison to placebo.

- Investigate the relationship between the secondary outcome variables (prealbumin,
triceps skin fold, mid-upper arm circumference, and weight loss)from baseline to end of
treatment in each group (treatment and placebo) separately.

OUTLINE: This is a multicenter study. Patients are stratified according to enrolling center
and steroid use with cancer treatment (yes vs no). Study agent can start anytime up to and
including day 28 after the first dose of chemotherapy.

- Arm I: Patients receive oral cyproheptadine hydrochloride twice daily for 8 weeks.

- Arm II: Patients receive an oral placebo twice daily for 8 weeks.

Patients undergo weight and height measurements at baseline and at each follow-up visit in
weeks 4 and 8 to evaluate the effect of cyproheptadine hydrochloride and duration of
response. Patients or parents complete medicine logs at each follow-up visit in weeks 4 and
8 to evaluate drug compliance and tolerance. Patients also undergo measures of nutrition;
and measures of body composition, lean body mass, and fat percentage using standardized
equipment and procedures for measuring triceps skin fold and mid-arm muscle circumference at
baseline and at the end of the study.

Patients undergo blood sample collection at baseline and at the end of the study for
biomarker studies. Samples are analyzed for pre-albumin levels.

INCLUSION CRITERIA:

- ≥ 2 years and ≤ 21 years of age at the time of study entry

- Scheduled to receive chemotherapy for:

- Newly diagnosed:

- Non-rhabdo soft tissue sarcomas, scheduled to receive chemotherapy, as well as
intermediate or high-risk rhabdomyosarcoma, any stage osteosarcoma and any stage
Ewing's sarcoma

- Intermediate or high-risk neuroblastoma

- Wilms' tumor (Stage III/IV)

- Hepatoblastoma (Stage III/IV)

- Germ cell tumors (Stage III/IV)

- Brain tumors, including medulloblastoma, PNET and ependymomas

- AML

- Relapsed/recurrent disease (any patient)

- Able to register and randomize within 28 days of starting chemotherapy (registration
/randomization and start of study agent may occur at anytime up to and including Day
28 after the initiation of chemotherapy)

EXCLUSION CRITERIA:

- ≥ 29 days after starting chemotherapy

- Documented history of unintended weight loss ≥ 5% presumed secondary to cancer within
3 months of study entry

- Currently taking cyproheptadine HCl (or have taken cyproheptadine HCl within 3 weeks
of study registration)

- History of anorexia nervosa or bulimia

- Taking other appetite-stimulating medications, i.e. dronabinol (Marinol) during the
past three weeks.

- Initiation of other appetite enhancing agents, including steroids prescribed for the
intent of weight gain, i.e. Megace. Note: Other forms of nutrition therapies, e.g.
appetite-stimulating medications, TPN or enteral tube feedings are not allowed during
this study.

- Children receiving steroids for >7 days as part of their cancer treatment regimen are
excluded from participation. However, intermittent steroid use in an antiemetic
regimen is allowed during the study

- Receiving monoamine oxidase (MAO) inhibitors, procarbazine, fluoxetine (Prozac), or
paroxetine (Paxil)

- Diagnosed with glaucoma, cystic fibrosis, inflammatory bowel disease, or GI/GU
obstruction

- Allergy to cyproheptadine HCl

- Females of childbearing age must not be pregnant.

- Female patients who are lactating must agree to stop breast-feeding.
We found this trial at
14
sites
111 Michigan Ave NW
Washington, District of Columbia
(202) 476-5000
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
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282 Washington St
Hartford, Connecticut 06106
(860) 545-9000
Connecticut Children's Medical Center Connecticut Children’s Medical Center is a nationally recognized, 187-bed not-for-profit children’s...
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Hartford, CT
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807 Childrens Way
Jacksonville, Florida 32207
(904) 697-3600
Nemours Children's Clinic At Nemours Children’s Clinic, Jacksonville, we've treated every child as we would...
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Jacksonville, FL
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601 Children's Lane
Norfolk, Virginia 23507
(757) 668-7000
Children's Hospital of The King's Daughters Children
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Norfolk, VA
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1717 South Orange Avenue # 100
Orlando, Florida 32806
(407) 650-7000
Nemours Children's Clinic - Orlando Located near downtown Orlando, Nemours Children’s Clinic, Orlando is a...
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Orlando, FL
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Fort Myers, FL
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1319 Punahou St
Honolulu, Hawaii 96826
(808) 983-6000
Kapiolani Medical Center for Women and Children Hawai‘i Pacific Health is an integrated health care...
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Honolulu, HI
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2801 Atlantic Ave
Long Beach, California 90806
(562) 933-5437
Miller Children's Hospital Miller Children
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Long Beach, CA
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1514 Jefferson Hwy.
New Orleans, Louisiana 70121
504-842-3000
Ochsner Medical Center Ochsner Medical Center is located near uptown New Orleans and includes acute...
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New Orleans, LA
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630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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New York, NY
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Orlando, Florida 32806
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Orlando, FL
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Pensacola, Florida 32504
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San Antonio, Texas 78207
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San Antonio, TX
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Wilmington, Delaware 19803
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Wilmington, DE
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