Trial Outcomes & Findings for Cyproheptadine Hydrochloride and Nutritional Supplementation in Treating Young Patients With Weight Loss With Cancer (NCT NCT00949117)

NCT ID: NCT00949117

Last Updated: 2014-04-02

Results Overview

Difference in measure of weight in kilograms of subject at baseline and at week 24 after continuing on study treatment for the entire 24 week period.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 9 participants
• Primary outcome timeframe: 24 weeks
• Results posted on: 2014-04-02

Participant Flow

Participant milestones

Measure	Arm I- Cyproheptadine Hydrochloride Patients receive oral cyproheptadine hydrochloride twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.	Arm II Cyproheptadine HCl and PediaSure or Ensure Patients receive oral cyproheptadine hydrochloride twice daily and oral PediaSure (2 to 10 years of age) or Ensure (\> 10 years of age) twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
Overall Study STARTED	4	5
Overall Study COMPLETED	1	0
Overall Study NOT COMPLETED	3	5

Reasons for withdrawal

Measure	Arm I- Cyproheptadine Hydrochloride Patients receive oral cyproheptadine hydrochloride twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.	Arm II Cyproheptadine HCl and PediaSure or Ensure Patients receive oral cyproheptadine hydrochloride twice daily and oral PediaSure (2 to 10 years of age) or Ensure (\> 10 years of age) twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
Overall Study Lack of Efficacy	2	3
Overall Study Protocol Violation	1	1
Overall Study Adverse Event	0	1

Baseline Characteristics

Cyproheptadine Hydrochloride and Nutritional Supplementation in Treating Young Patients With Weight Loss With Cancer

Baseline characteristics by cohort

Measure	Arm I- Cyproheptadine Hydrochloride n=4 Participants Patients receive oral cyproheptadine hydrochloride twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.	Arm II Cyproheptadine HCl and PediaSure or Ensure n=5 Participants Patients receive oral cyproheptadine hydrochloride twice daily and oral PediaSure (2 to 10 years of age) or Ensure (\> 10 years of age) twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.	Total n=9 Participants Total of all reporting groups
Age, Categorical <=18 years	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	9.1 years STANDARD_DEVIATION 5.5 • n=5 Participants	13.3 years STANDARD_DEVIATION 5.1 • n=7 Participants	11.4 years STANDARD_DEVIATION 5.1 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants	5 participants n=7 Participants	9 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks

Difference in measure of weight in kilograms of subject at baseline and at week 24 after continuing on study treatment for the entire 24 week period.

Outcome measures

Measure	Arm I- Cyproheptadine Hydrochloride n=1 Participants Patients receive oral cyproheptadine hydrochloride twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.	Arm II Cyproheptadine HCl and PediaSure or Ensure Patients receive oral cyproheptadine hydrochloride twice daily and oral PediaSure (2 to 10 years of age) or Ensure (\> 10 years of age) twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
Difference Between Measures of Weight at Baseline and at Week 24	4.3 kilograms	—

SECONDARY outcome

Timeframe: 24 weeks

Change in Body Mass Index (BMI) in subjects from Baseline visit to 24 week visit.

Outcome measures

Measure	Arm I- Cyproheptadine Hydrochloride n=1 Participants Patients receive oral cyproheptadine hydrochloride twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.	Arm II Cyproheptadine HCl and PediaSure or Ensure Patients receive oral cyproheptadine hydrochloride twice daily and oral PediaSure (2 to 10 years of age) or Ensure (\> 10 years of age) twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
Body Mass Index as Assessed at Baseline and 24 Weeks	1.9 kg/m^2	—

SECONDARY outcome

Timeframe: 24 weeks

Population: Outcome not assessed as the one subject that completed the protocol did not have the prealbumin lab drawn at the 24 week visit and body composition tests assessed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 weeks

Population: Outcome not assessed as the one subject that completed the protocol was too young to complete the PedsFAACT quality of life assessment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and 24 weeks

Change in weight for age Z-score from Baseline through 24 weeks while on study treatment. Weight for age Z-score calculated using the Center for Disease Control and Prevention (CDC) weight-for-age Z score data tables.

Outcome measures

Measure	Arm I- Cyproheptadine Hydrochloride n=1 Participants Patients receive oral cyproheptadine hydrochloride twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.	Arm II Cyproheptadine HCl and PediaSure or Ensure Patients receive oral cyproheptadine hydrochloride twice daily and oral PediaSure (2 to 10 years of age) or Ensure (\> 10 years of age) twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
Change in Weight for Age Z-score From Baseline Through 24 Weeks	1.47 z score Standard Deviation 0	—

Adverse Events

Arm I- Cyproheptadine Hydrochloride

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Arm II Cyproheptadine HCl and PediaSure or Ensure

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Arm I- Cyproheptadine Hydrochloride n=4 participants at risk Patients receive oral cyproheptadine hydrochloride twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.	Arm II Cyproheptadine HCl and PediaSure or Ensure n=5 participants at risk Patients receive oral cyproheptadine hydrochloride twice daily and oral PediaSure (2 to 10 years of age) or Ensure (\> 10 years of age) twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
General disorders somnolence	25.0% 1/4 • Number of events 1 • 24 weeks Subjects and their parents reported any adverse symptoms or events via daily study medication logs. Site personnel reviewed logs at in-person visits at weeks 4, 8, 12, 16, 20 and 24 and assessed subject for any adverse events. All Adverse events and Serious Adverse events reviewed by independent DSMB.	0.00% 0/5 • 24 weeks Subjects and their parents reported any adverse symptoms or events via daily study medication logs. Site personnel reviewed logs at in-person visits at weeks 4, 8, 12, 16, 20 and 24 and assessed subject for any adverse events. All Adverse events and Serious Adverse events reviewed by independent DSMB.
General disorders relapse of cancer	0.00% 0/4 • 24 weeks Subjects and their parents reported any adverse symptoms or events via daily study medication logs. Site personnel reviewed logs at in-person visits at weeks 4, 8, 12, 16, 20 and 24 and assessed subject for any adverse events. All Adverse events and Serious Adverse events reviewed by independent DSMB.	20.0% 1/5 • Number of events 1 • 24 weeks Subjects and their parents reported any adverse symptoms or events via daily study medication logs. Site personnel reviewed logs at in-person visits at weeks 4, 8, 12, 16, 20 and 24 and assessed subject for any adverse events. All Adverse events and Serious Adverse events reviewed by independent DSMB.
Skin and subcutaneous tissue disorders rash	0.00% 0/4 • 24 weeks Subjects and their parents reported any adverse symptoms or events via daily study medication logs. Site personnel reviewed logs at in-person visits at weeks 4, 8, 12, 16, 20 and 24 and assessed subject for any adverse events. All Adverse events and Serious Adverse events reviewed by independent DSMB.	20.0% 1/5 • Number of events 1 • 24 weeks Subjects and their parents reported any adverse symptoms or events via daily study medication logs. Site personnel reviewed logs at in-person visits at weeks 4, 8, 12, 16, 20 and 24 and assessed subject for any adverse events. All Adverse events and Serious Adverse events reviewed by independent DSMB.
Gastrointestinal disorders flatulence	0.00% 0/4 • 24 weeks Subjects and their parents reported any adverse symptoms or events via daily study medication logs. Site personnel reviewed logs at in-person visits at weeks 4, 8, 12, 16, 20 and 24 and assessed subject for any adverse events. All Adverse events and Serious Adverse events reviewed by independent DSMB.	20.0% 1/5 • Number of events 1 • 24 weeks Subjects and their parents reported any adverse symptoms or events via daily study medication logs. Site personnel reviewed logs at in-person visits at weeks 4, 8, 12, 16, 20 and 24 and assessed subject for any adverse events. All Adverse events and Serious Adverse events reviewed by independent DSMB.

Additional Information

Cristina Burroughs, Clinical Research Coordinator

SunCoast CCOP Research Base

Phone: (813) 396-9237

Email: Cristina.Burroughs@epi.usf.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place