A Phase 2 interventional study of Ensure and PediaSure in Leukemia, Lymphoma and Malnutrition, sponsored by University of South Florida. Terminated. Open to participants aged 2 Years to 17 Years. Per ClinicalTrials.gov, last updated 2014-04-02.
Sponsored by University of South Florida · Phase 2, Interventional, and Supportive care
RATIONALE: Cyproheptadine hydrochloride may help improve appetite and lessen weight loss caused by cancer or cancer treatment. It is not yet known whether cyproheptadine hydrochloride is more effective with or without nutritional supplementation in improving weight and quality of life of young patients with weight loss caused by cancer or cancer treatment.
PURPOSE: This randomized phase II trial is studying cyproheptadine hydrochloride to see how well it works when given together with or without nutritional supplementation in treating young patients with weight loss caused by cancer or cancer treatment.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to participating center and steroid use (yes vs no). Patients are randomized to 1 of 2 treatment arms.
Patients undergo blood sample collection to assess pre-albumin levels at baseline and at weeks 4 and 24. Patients also undergo assessment of body composition, lean body mass, and percentage of body fat at baseline and at weeks 4 and 24 and assessment of weight and height at baseline and at weeks 4, 8, 12, 16, 20, and 24. Patients also complete a food diary twice a week during study treatment.
Patients 7-17 years of age complete a quality-of-life questionnaire at baseline and at weeks 4 and 24.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 9 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →University of South Florida is the lead sponsor of 333 studies on the registry; 63 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 4 (24%) have results posted.
Counted across the registry records on this site, refreshed daily.
EXCLUSION CRITERIA:
Patients receive oral cyproheptadine hydrochloride twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
Drug: cyproheptadine hydrochloride
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.
Dietary Supplement: Ensure · Dietary Supplement: PediaSure · Drug: cyproheptadine hydrochloride
Given orally
Also known as: nutritional supplement drink
Given orally
Also known as: nutritional supplement drink (pediatric)
Given orally
Also known as: cyproheptadine HCl
Difference Between Measures of Weight at Baseline and at Week 24
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.
Time frame: 24 weeks
Body Mass Index as Assessed at Baseline and 24 Weeks
Change in Body Mass Index (BMI) in subjects from Baseline visit to 24 week visit.
Time frame: 24 weeks
Effect of Cyproheptadine Hydrochloride on Pre-albumin and Body Composition
Time frame: 24 weeks
Quality of Life as Assessed by Peds-FAACT Questionnaire at Baseline and at Weeks 4 and 24
Time frame: 24 weeks
Change in Weight for Age Z-score From Baseline Through 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.
Time frame: Baseline and 24 weeks
| Milestone | Arm I- Cyproheptadine Hydrochloride | Arm II Cyproheptadine HCl and PediaSure or Ensure |
|---|---|---|
| Started | 4 | 5 |
| Completed | 1 | 0 |
| Not completed | 3 | 5 |
| Withdrew: Lack of efficacy | 2 | 3 |
| Withdrew: Protocol violation | 1 | 1 |
| Withdrew: Adverse event | 0 | 1 |
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.
| kilograms | Arm I- Cyproheptadine Hydrochloride | Arm II Cyproheptadine HCl and PediaSure or Ensure |
|---|---|---|
| Difference Between Measures of Weight at Baseline and at Week 24 | 4.3 | — |
Change in Body Mass Index (BMI) in subjects from Baseline visit to 24 week visit.
| kg/m^2 | Arm I- Cyproheptadine Hydrochloride | Arm II Cyproheptadine HCl and PediaSure or Ensure |
|---|---|---|
| Body Mass Index as Assessed at Baseline and 24 Weeks | 1.9 | — |
No measurements were reported for this outcome.
No measurements were reported for this outcome.
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.
| z score | Arm I- Cyproheptadine Hydrochloride | Cyproheptadine HCl & PediaSure or Ensure |
|---|---|---|
| Change in Weight for Age Z-score From Baseline Through 24 Weeks | 1.47 ± 0 | — |
Collected over 24 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm I- Cyproheptadine Hydrochloride | — | 0/4 (0%) | 1/4 (25%) |
| Arm II Cyproheptadine HCl and PediaSure or Ensure | — | 0/5 (0%) | 2/5 (40%) |
| Event | Arm I- Cyproheptadine Hydrochloride | Arm II Cyproheptadine HCl and PediaSure or Ensure |
|---|---|---|
| somnolenceGeneral disorders | 1/4 | 0/5 |
| relapse of cancerGeneral disorders | 0/4 | 1/5 |
| rashSkin and subcutaneous tissue disorders | 0/4 | 1/5 |
| flatulenceGastrointestinal disorders | 0/4 | 1/5 |
| Age, Categorical(Participants) | Arm I- Cyproheptadine Hydrochloride | Arm II Cyproheptadine HCl and PediaSure or Ensure | Total |
|---|---|---|---|
| <=18 years | 4 | 5 | 9 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Arm I- Cyproheptadine Hydrochloride | Arm II Cyproheptadine HCl and PediaSure or Ensure | Total |
|---|---|---|---|
| Mean | 9.1 ± 5.5 | 13.3 ± 5.1 | 11.4 ± 5.1 |
| Sex: Female, Male(Participants) | Arm I- Cyproheptadine Hydrochloride | Arm II Cyproheptadine HCl and PediaSure or Ensure | Total |
|---|---|---|---|
| Female | 2 | 0 | 2 |
| Male | 2 | 5 | 7 |
| Region of Enrollment(participants) | Arm I- Cyproheptadine Hydrochloride | Arm II Cyproheptadine HCl and PediaSure or Ensure | Total |
|---|---|---|---|
| United States | 4 | 5 | 9 |
No study locations are listed for this record.
This study is terminated, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.
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University of South Florida