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: June 4, 2015
Last verified: June 2015
Results First Received: January 12, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Supportive Care
Condition: Cancer
Interventions: Drug: cyproheptadine hydrochloride
Other: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Arm I Cyproheptadine Hydrochloride

Patients receive oral cyproheptadine hydrochloride twice daily for 8 weeks.

cyproheptadine hydrochloride: Given orally

Arm II Placebo

Patients receive an oral placebo twice daily for 8 weeks.

placebo: Given orally


Participant Flow:   Overall Study
    Arm I Cyproheptadine Hydrochloride     Arm II Placebo  
STARTED     9     13  
COMPLETED     5     12  
NOT COMPLETED     4     1  
Withdrawal by Subject                 3                 1  
Death                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Arm I Cyproheptadine Hydrochloride

Patients receive oral cyproheptadine hydrochloride twice daily for 8 weeks.

cyproheptadine hydrochloride: Given orally

Arm II Placebo

Patients receive an oral placebo twice daily for 8 weeks.

placebo: Given orally

Total Total of all reporting groups

Baseline Measures
    Arm I Cyproheptadine Hydrochloride     Arm II Placebo     Total  
Number of Participants  
[units: participants]
  9     13     22  
Age  
[units: years]
Mean (Standard Deviation)
  10.2  (5.7)     12.0  (4.7)     11.2  (5.1)  
Gender  
[units: participants]
     
Female     3     10     13  
Male     6     3     9  
Region of Enrollment  
[units: participants]
     
United States     9     13     22  



  Outcome Measures
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1.  Primary:   Participant With Weight Loss ≥ 5% at the 8- Week Assessment When Compared to Baseline   [ Time Frame: 8 weeks ]

2.  Primary:   Severity of Weight Loss   [ Time Frame: Baseline and 8 weeks ]

3.  Secondary:   Pattern of Weight in the Study Population   [ Time Frame: Baseline and 8 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Angelina Fink, Research Base Administrator
Organization: SunCoast CCOP Research Base at the University of South Florida
phone: 813-396-9245
e-mail: angelina.fink@epi.usf.edu


No publications provided


Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT01132547     History of Changes
Other Study ID Numbers: SCUSF 0703, SCUSF-0703, 5U10CA081920-11
Study First Received: May 26, 2010
Results First Received: January 12, 2015
Last Updated: June 4, 2015
Health Authority: United States: Data and Safety Monitoring Board
United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board