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Cyproheptadine in Preventing Weight Loss in Children Receiving Chemotherapy for Cancer

This study has been terminated.
(The study was terminated due to slow accrual.)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of South Florida
ClinicalTrials.gov Identifier:
NCT01132547
First received: May 26, 2010
Last updated: January 31, 2014
Last verified: January 2014

May 26, 2010
January 31, 2014
June 2010
January 2014   (final data collection date for primary outcome measure)
  • Efficacy of cyproheptadine HCl in the prevention of cancer/treatment-related weight loss, defined as weight loss ≥ 5% at the 4 or 8- week assessment when compared to baseline [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • Severity of weight loss [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Incidence rate at the end of 16 weeks [ Designated as safety issue: Yes ]
  • Severity of weight loss [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01132547 on ClinicalTrials.gov Archive Site
  • Pattern of weight in the study population [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Comparison on the change for prealbumin of malnourishment and body composition between groups [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Comparison of the effect of cyproheptadine hydrochloride on prealbumin levels of malnourishment and on body composition within the treatment group at completion of therapy, baseline, and post-intervention [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Comparison of the changes between those with and without weight loss within treatment groups [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • Pattern of weight in the study population [ Designated as safety issue: No ]
  • Duration of response [ Designated as safety issue: No ]
  • Comparison on the change for each biomarker (prealbumin and transferrin) of malnourishment and body composition between groups [ Designated as safety issue: No ]
  • Comparison of the effect of cyproheptadine hydrochloride on each biomarker (prealbumin and transferrin) of malnourishment and on body composition within the treatment group at completion of therapy, baseline, and post-intervention [ Designated as safety issue: No ]
  • Comparison of the changes between those with and without weight loss within treatment groups [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Cyproheptadine in Preventing Weight Loss in Children Receiving Chemotherapy for Cancer
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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
Cancer
  • Drug: cyproheptadine hydrochloride
    Given orally
    Other Name: cyproheptadine HCl
  • Other: placebo
    Given orally
  • Experimental: Arm I cyproheptadine hydrochloride
    Patients receive oral cyproheptadine hydrochloride twice daily for 8 weeks.
    Intervention: Drug: cyproheptadine hydrochloride
  • Placebo Comparator: Arm II placebo
    Patients receive an oral placebo twice daily for 8 weeks.
    Intervention: Other: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
22
January 2014
January 2014   (final data collection date for primary outcome measure)

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.
Both
2 Years to 21 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01132547
SCUSF 0703, SCUSF-0703, 5U10CA081920-11
Yes
University of South Florida
University of South Florida
National Cancer Institute (NCI)
Principal Investigator: Jeffrey P. Krischer, PhD University of South Florida
University of South Florida
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP