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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
Enrollment 22
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I Cyproheptadine Hydrochloride Arm II Placebo
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Patients receive oral cyproheptadine hydrochloride twice daily for 8 weeks.

cyproheptadine hydrochloride: Given orally

Patients receive an oral placebo twice daily for 8 weeks.

placebo: Given orally

Period Title: Overall Study
Started 9 13
Completed 5 12
Not Completed 4 1
Reason Not Completed
Withdrawal by Subject             3             1
Death             1             0
Arm/Group Title Arm I Cyproheptadine Hydrochloride Arm II Placebo Total
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Patients receive oral cyproheptadine hydrochloride twice daily for 8 weeks.

cyproheptadine hydrochloride: Given orally

Patients receive an oral placebo twice daily for 8 weeks.

placebo: Given orally

Total of all reporting groups
Overall Number of Baseline Participants 9 13 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants 13 participants 22 participants
10.2  (5.7) 12.0  (4.7) 11.2  (5.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 13 participants 22 participants
Female
3
  33.3%
10
  76.9%
13
  59.1%
Male
6
  66.7%
3
  23.1%
9
  40.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 9 participants 13 participants 22 participants
9 13 22
1.Primary Outcome
Title Participant With Weight Loss ≥ 5% at the 8- Week Assessment When Compared to Baseline
Hide Description [Not Specified]
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
LOCF
Arm/Group Title Arm I Cyproheptadine Hydrochloride Arm II Placebo
Hide Arm/Group Description:

Patients receive oral cyproheptadine hydrochloride twice daily for 8 weeks.

cyproheptadine hydrochloride: Given orally

Patients receive an oral placebo twice daily for 8 weeks.

placebo: Given orally

Overall Number of Participants Analyzed 9 13
Measure Type: Number
Unit of Measure: participants
0 2
2.Primary Outcome
Title Severity of Weight Loss
Hide Description Change from Baseline in Weight Z score
Time Frame Baseline and 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Completers =
Arm/Group Title Arm I Cyproheptadine Hydrochloride Arm II Placebo
Hide Arm/Group Description:

Patients receive oral cyproheptadine hydrochloride twice daily for 8 weeks.

cyproheptadine hydrochloride: Given orally

Patients receive an oral placebo twice daily for 8 weeks.

placebo: Given orally

Overall Number of Participants Analyzed 5 12
Mean (Standard Deviation)
Unit of Measure: Z score
0.12  (1.15) -0.02  (0.30)
3.Secondary Outcome
Title Pattern of Weight in the Study Population
Hide Description Change from Baseline in Weight
Time Frame Baseline and 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Completers
Arm/Group Title Arm I Cyproheptadine Hydrochloride Arm II Placebo
Hide Arm/Group Description:

Patients receive oral cyproheptadine hydrochloride twice daily for 8 weeks.

cyproheptadine hydrochloride: Given orally

Patients receive an oral placebo twice daily for 8 weeks.

placebo: Given orally

Overall Number of Participants Analyzed 5 12
Mean (Standard Deviation)
Unit of Measure: Kilograms
0.18  (0.79) -0.32  (3.13)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm I Cyproheptadine Hydrochloride Arm II Placebo
Hide Arm/Group Description

Patients receive oral cyproheptadine hydrochloride twice daily for 8 weeks.

cyproheptadine hydrochloride: Given orally

Patients receive an oral placebo twice daily for 8 weeks.

placebo: Given orally

All-Cause Mortality
Arm I Cyproheptadine Hydrochloride Arm II Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm I Cyproheptadine Hydrochloride Arm II Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/9 (33.33%)      0/13 (0.00%)    
Blood and lymphatic system disorders     
Febrile Neutropenia   2/9 (22.22%)  3 0/13 (0.00%)  0
Investigations     
Platelet count decrease   2/9 (22.22%)  2 0/13 (0.00%)  0
Neutrophil count decrease   1/9 (11.11%)  2 0/13 (0.00%)  0
Nervous system disorders     
Intracranial hemorrhage   1/9 (11.11%)  1 0/13 (0.00%)  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm I Cyproheptadine Hydrochloride Arm II Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/9 (44.44%)      4/13 (30.77%)    
Blood and lymphatic system disorders     
Anemia   2/9 (22.22%)  4 0/13 (0.00%)  0
Febrile neutropenia   1/9 (11.11%)  1 0/13 (0.00%)  0
Cardiac disorders     
Tachycardia NOS   0/9 (0.00%)  0 1/13 (7.69%)  1
Gastrointestinal disorders     
Abdominal pain   1/9 (11.11%)  1 1/13 (7.69%)  1
Constipation   0/9 (0.00%)  0 1/13 (7.69%)  1
Mucositis oral   1/9 (11.11%)  1 0/13 (0.00%)  0
Nausea   0/9 (0.00%)  0 1/13 (7.69%)  1
General disorders     
Fever   2/9 (22.22%)  3 0/13 (0.00%)  0
Pain   1/9 (11.11%)  1 0/13 (0.00%)  0
Immune system disorders     
Allergic reaction   1/9 (11.11%)  1 0/13 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Pain in extremity   1/9 (11.11%)  1 0/13 (0.00%)  0
Nervous system disorders     
Headache   1/9 (11.11%)  1 1/13 (7.69%)  1
Somnolence   0/9 (0.00%)  0 1/13 (7.69%)  1
Psychiatric disorders     
Insomnia   0/9 (0.00%)  0 1/13 (7.69%)  1
Skin and subcutaneous tissue disorders     
Skin and Subcutaneous tissue disorders other   2/9 (22.22%)  2 1/13 (7.69%)  1
Vascular disorders     
Hypertension   1/9 (11.11%)  1 0/13 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Angelina Fink, Research Base Administrator
Organization: SunCoast CCOP Research Base at the University of South Florida
Phone: 813-396-9245
EMail: angelina.fink@epi.usf.edu
Layout table for additonal information
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