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Cyproheptadine in Preventing Weight Loss in Children Receiving Chemotherapy for Cancer

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ClinicalTrials.gov Identifier: NCT01132547
Recruitment Status : Terminated (The study was terminated due to slow accrual.)
First Posted : May 28, 2010
Results First Posted : July 2, 2015
Last Update Posted : July 2, 2015
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of South Florida

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Supportive Care
Condition: Cancer
Interventions: Drug: cyproheptadine hydrochloride
Other: placebo

  Participant Flow

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

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.
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

Total Total of all reporting groups

Baseline Measures
   Arm I Cyproheptadine Hydrochloride   Arm II Placebo   Total 
Overall Participants Analyzed 
[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

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

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

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



Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT01132547     History of Changes
Other Study ID Numbers: SCUSF 0703
SCUSF-0703 ( Other Identifier: SunCoast CCOP Research Base )
5U10CA081920-11 ( U.S. NIH Grant/Contract )
First Submitted: May 26, 2010
First Posted: May 28, 2010
Results First Submitted: January 12, 2015
Results First Posted: July 2, 2015
Last Update Posted: July 2, 2015