NCT00949117 is a Phase 2 clinical trial of Ensure in Leukemia, sponsored by University of South Florida.

Who is sponsoring NCT00949117?

NCT00949117 is sponsored by University of South Florida.

What drugs are being tested in NCT00949117?

Interventions in NCT00949117: Ensure, PediaSure, cyproheptadine hydrochloride.

What condition does NCT00949117 study?

NCT00949117 studies Leukemia, Lymphoma, Malnutrition, Myelodysplastic Syndromes, Unspecified Childhood Solid Tumor, Protocol Specific, Weight Changes.

Is NCT00949117 still recruiting?

NCT00949117 is currently terminated. Last updated 4 March 2014.

Are results published for NCT00949117?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2014-03-04 · How we verify

NCT00949117

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

An Open Label Randomized Phase II Study of an Appetite Stimulant, Cyproheptadine Hydrochloride, With and Without a Nutritional Supplement, in Children With Cancer/Treatment-Related Weight Loss

Terminated Phase 2 Results posted Last updated 4 March 2014

What this trial tests

Phase 2 trial testing Ensure in Leukemia in 9 participants. Terminated before completion.

Timeline

1 September 2009

Primary endpoint
1 November 2011

1 November 2011

Quick facts

Lead sponsor	University of South Florida
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	9
Start date	1 September 2009
Primary completion	1 November 2011
Estimated completion	1 November 2011

Drugs / interventions tested

Ensure
PediaSure — full drug profile →
cyproheptadine hydrochloride (CYPROHEPTADINE) — full drug profile →

Conditions studied

Leukemia — all drugs for Leukemia →
Lymphoma — all drugs for Lymphoma →
Malnutrition — all drugs for Malnutrition →
Myelodysplastic Syndromes — all drugs for Myelodysplastic Syndromes →

Sponsor

University of South Florida

Who can join

Adults 2 to 17, any sex, with Leukemia or Lymphoma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Difference Between Measures of Weight at Baseline and at Week 24
Time frame: 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.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of Ensure

Trials testing the same drug.

NCT06311357 — Percent Weight Change in the Medical Supplement Group of Early Breast Cancer · NA · unknown
NCT04210284 — Oral Nutritional Optimization in Total Joint Arthroplasty · NA · recruiting
NCT04464161 — The Effects of Perioperative Nutritional Optimization on Blood Markers · NA · completed
NCT03470181 — Applying Nutrient Drink Test in Understanding Pathophysiology of CVS · completed
NCT02624752 — Oral Nutrition Supplementation in Hospitalized Patients · NA · completed

Other recruiting trials for Leukemia

Currently open trials in the same condition.

NCT07405424 — Spiritual Care Intervention in Adult Patients Diagnosed With Acute Leukemia · NA · recruiting
NCT07249346 — Dose-Expansion Study of Low Dose Post-Transplant Cyclophosphamide/Tacrolimus/Ruxolitinib for Graft-versus-Host Disease ( · Phase 2 · recruiting
NCT07566377 — Cord Blood Transplantation in Children and Young Adults With Blood Cancer · Phase 2 · recruiting
NCT06856226 — Natural History Study to Determine Drug Metabolism Phenotype and Appropriate Germline Source DNA in Patients Undergoing · recruiting
NCT07148180 — A Multi-Site Break Through Cancer Trial: Targeting Measurable Residual Disease in Patients With Acute Myeloid Leukemia: · Phase 1, PHASE2 · recruiting

Other University of South Florida trials

Trials by the same sponsor.

NCT07529366 — Pharmacist-Led Continuous Glucose Monitoring for Prediabetes · recruiting
NCT07342569 — The WeACT Program for Family Caregivers of People Living With Dementia · NA · not yet recruiting
NCT07502378 — Effect of Acoltremon Ophthalmic Solution 0.003% on Signs and Symptoms of Ocular Surface Disease in Stage I Neurotrophic · Phase 4 · recruiting
NCT07241260 — Hydrate Heroes for Improving Brain Function & Mood · NA · not yet recruiting
NCT06377215 — Understanding Aided Speech Perception in Noise · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00949117 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of South Florida
Last refreshed: 4 March 2014

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00949117.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing