Trial Outcomes & Findings for Cyproheptadine in Preventing Weight Loss in Children Receiving Chemotherapy for Cancer (NCT NCT01132547)
NCT ID: NCT01132547
Last Updated: 2015-07-02
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
22 participants
Primary outcome timeframe
8 weeks
Results posted on
2015-07-02
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
13
|
|
Overall Study
COMPLETED
|
5
|
12
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
| Measure |
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
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
|
Overall Study
Death
|
1
|
0
|
Baseline Characteristics
Cyproheptadine in Preventing Weight Loss in Children Receiving Chemotherapy for Cancer
Baseline characteristics by cohort
| Measure |
Arm I Cyproheptadine Hydrochloride
n=9 Participants
Patients receive oral cyproheptadine hydrochloride twice daily for 8 weeks.
cyproheptadine hydrochloride: Given orally
|
Arm II Placebo
n=13 Participants
Patients receive an oral placebo twice daily for 8 weeks.
placebo: Given orally
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
10.2 years
STANDARD_DEVIATION 5.7 • n=99 Participants
|
12.0 years
STANDARD_DEVIATION 4.7 • n=107 Participants
|
11.2 years
STANDARD_DEVIATION 5.1 • n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=99 Participants
|
13 participants
n=107 Participants
|
22 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: LOCF
Outcome measures
| Measure |
Arm I Cyproheptadine Hydrochloride
n=9 Participants
Patients receive oral cyproheptadine hydrochloride twice daily for 8 weeks.
cyproheptadine hydrochloride: Given orally
|
Arm II Placebo
n=13 Participants
Patients receive an oral placebo twice daily for 8 weeks.
placebo: Given orally
|
|---|---|---|
|
Participant With Weight Loss ≥ 5% at the 8- Week Assessment When Compared to Baseline
|
0 participants
|
2 participants
|
PRIMARY outcome
Timeframe: Baseline and 8 weeksPopulation: Completers =
Change from Baseline in Weight Z score
Outcome measures
| Measure |
Arm I Cyproheptadine Hydrochloride
n=5 Participants
Patients receive oral cyproheptadine hydrochloride twice daily for 8 weeks.
cyproheptadine hydrochloride: Given orally
|
Arm II Placebo
n=12 Participants
Patients receive an oral placebo twice daily for 8 weeks.
placebo: Given orally
|
|---|---|---|
|
Severity of Weight Loss
|
0.12 Z score
Standard Deviation 1.15
|
-0.02 Z score
Standard Deviation 0.30
|
SECONDARY outcome
Timeframe: Baseline and 8 weeksPopulation: Completers
Change from Baseline in Weight
Outcome measures
| Measure |
Arm I Cyproheptadine Hydrochloride
n=5 Participants
Patients receive oral cyproheptadine hydrochloride twice daily for 8 weeks.
cyproheptadine hydrochloride: Given orally
|
Arm II Placebo
n=12 Participants
Patients receive an oral placebo twice daily for 8 weeks.
placebo: Given orally
|
|---|---|---|
|
Pattern of Weight in the Study Population
|
0.18 Kilograms
Standard Deviation 0.79
|
-0.32 Kilograms
Standard Deviation 3.13
|
Adverse Events
Arm I Cyproheptadine Hydrochloride
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
Arm II Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I Cyproheptadine Hydrochloride
n=9 participants at risk
Patients receive oral cyproheptadine hydrochloride twice daily for 8 weeks.
cyproheptadine hydrochloride: Given orally
|
Arm II Placebo
n=13 participants at risk
Patients receive an oral placebo twice daily for 8 weeks.
placebo: Given orally
|
|---|---|---|
|
Nervous system disorders
Intracranial hemorrhage
|
11.1%
1/9 • Number of events 1
|
0.00%
0/13
|
|
Investigations
Platelet count decrease
|
22.2%
2/9 • Number of events 2
|
0.00%
0/13
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
22.2%
2/9 • Number of events 3
|
0.00%
0/13
|
|
Investigations
Neutrophil count decrease
|
11.1%
1/9 • Number of events 2
|
0.00%
0/13
|
Other adverse events
| Measure |
Arm I Cyproheptadine Hydrochloride
n=9 participants at risk
Patients receive oral cyproheptadine hydrochloride twice daily for 8 weeks.
cyproheptadine hydrochloride: Given orally
|
Arm II Placebo
n=13 participants at risk
Patients receive an oral placebo twice daily for 8 weeks.
placebo: Given orally
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
22.2%
2/9 • Number of events 4
|
0.00%
0/13
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
11.1%
1/9 • Number of events 1
|
0.00%
0/13
|
|
Gastrointestinal disorders
Abdominal pain
|
11.1%
1/9 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.1%
1/9 • Number of events 1
|
0.00%
0/13
|
|
Nervous system disorders
Headache
|
11.1%
1/9 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin and Subcutaneous tissue disorders other
|
22.2%
2/9 • Number of events 2
|
7.7%
1/13 • Number of events 1
|
|
Immune system disorders
Allergic reaction
|
11.1%
1/9 • Number of events 1
|
0.00%
0/13
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/9
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Fever
|
22.2%
2/9 • Number of events 3
|
0.00%
0/13
|
|
Vascular disorders
Hypertension
|
11.1%
1/9 • Number of events 1
|
0.00%
0/13
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/9
|
7.7%
1/13 • Number of events 1
|
|
Nervous system disorders
Somnolence
|
0.00%
0/9
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis oral
|
11.1%
1/9 • Number of events 1
|
0.00%
0/13
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/9
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Pain
|
11.1%
1/9 • Number of events 1
|
0.00%
0/13
|
|
Cardiac disorders
Tachycardia NOS
|
0.00%
0/9
|
7.7%
1/13 • Number of events 1
|
Additional Information
Angelina Fink, Research Base Administrator
SunCoast CCOP Research Base at the University of South Florida
Phone: 813-396-9245
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place