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Cyproheptadine in Preventing Weight Loss in Children Receiving Chemotherapy for Cancer

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 2 Years - 21 Years
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT01132547
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University of South Florida
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Jeffrey P. Krischer, PhD
Principal Investigator Affiliation University of South Florida
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, NIH
Overall Status Terminated
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Cancer
Additional Details

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.#46;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.

Arms & Interventions

Arms

Experimental: Arm I cyproheptadine hydrochloride

Patients receive oral cyproheptadine hydrochloride twice daily for 8 weeks.

Placebo Comparator: Arm II placebo

Patients receive an oral placebo twice daily for 8 weeks.

Interventions

Drug: - cyproheptadine hydrochloride

Given orally

Other: - placebo

Given orally

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Miller Children's Hospital, Long Beach, California

Status

Address

Miller Children's Hospital

Long Beach, California, 90806

Connecticut Children's Medical Center, Hartford, Connecticut

Status

Address

Connecticut Children's Medical Center

Hartford, Connecticut, 06106

A.I. duPont Hospital for Children, Wilmington, Delaware

Status

Address

A.I. duPont Hospital for Children

Wilmington, Delaware, 19803

Children's National Medical Center, Washington, District of Columbia

Status

Address

Children's National Medical Center

Washington, District of Columbia, 20010

Fort Myers, Florida

Status

Address

Children's Hospital of Southwest Florida at Lee Memorial

Fort Myers, Florida, 33908

Nemours Children's Clinic - Jacksonville, Jacksonville, Florida

Status

Address

Nemours Children's Clinic - Jacksonville

Jacksonville, Florida, 32207-8482

Arnold Palmer Hospital for Children, Orlando, Florida

Status

Address

Arnold Palmer Hospital for Children

Orlando, Florida, 32806

Nemours Children's Clinic - Orlando, Orlando, Florida

Status

Address

Nemours Children's Clinic - Orlando

Orlando, Florida, 32806

Nemours Children's Hospital Pensacola, Pensacola, Florida

Status

Address

Nemours Children's Hospital Pensacola

Pensacola, Florida, 32504

Honolulu, Hawaii

Status

Address

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, 96826

Ochsner Clinic Foundation, New Orleans, Louisiana

Status

Address

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121

Columbia University Medical Center, New York, New York

Status

Address

Columbia University Medical Center

New York, New York, 10032

CHRISTUS Santa Rosa Children's Hospital, San Antonio, Texas

Status

Address

CHRISTUS Santa Rosa Children's Hospital

San Antonio, Texas, 78207

Norfolk, Virginia

Status

Address

Children's Hospital of The King's Daughters

Norfolk, Virginia, 23507

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