Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00066248
Status:
COMPLETED
Last Update Posted:
2014-02-03
First Post:
2003-08-06
Brief Title:
Cyproheptadine and Megestrol in Preventing Weight Loss in Children With Cachexia Caused By Cancer or Cancer Treatment
Sponsor:
University of South Florida
Organization:
University of South Florida
Study Overview
Official Title:
The Effect of Cyproheptadine Hydrochloride Periactin and Megestrol Acetate Megace on Weight in Children With CancerTreatment Related Cachexia
Status:
COMPLETED
Status Verified Date:
2014-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Cyproheptadine and megestrol may improve appetite and help prevent weight loss in children with cancer
PURPOSE This phase II trial is studying how well cyproheptadine and megestrol work in improving appetite and preventing weight loss in children with cachexia caused by cancer or cancer treatment
PURPOSE This phase II trial is studying how well cyproheptadine and megestrol work in improving appetite and preventing weight loss in children with cachexia caused by cancer or cancer treatment
Detailed Description:
OBJECTIVES
Determine the efficacy of cyproheptadine in preventing further weight loss in children with cancer or cancer treatment-related cachexia
Determine the efficacy of megestrol in preventing further weight loss in patients who dont respond to cyproheptadine
Determine how these drugs affect body protein and fat levels in these patients
OUTLINE Patients receive oral cyproheptadine twice daily for 4 weeks in the absence of unacceptable weight loss or toxicity Patients that present with weight loss after 4 weeks receive oral megestrol daily for 4 weeks in the absence of unacceptable weight loss or toxicity Patients responding to either cyproheptadine or megestrol may continue treatment at the discretion of the treating physician
Patients are followed at 4 weeks
PROJECTED ACCRUAL A total of 70 patients will be accrued for this study
Determine the efficacy of cyproheptadine in preventing further weight loss in children with cancer or cancer treatment-related cachexia
Determine the efficacy of megestrol in preventing further weight loss in patients who dont respond to cyproheptadine
Determine how these drugs affect body protein and fat levels in these patients
OUTLINE Patients receive oral cyproheptadine twice daily for 4 weeks in the absence of unacceptable weight loss or toxicity Patients that present with weight loss after 4 weeks receive oral megestrol daily for 4 weeks in the absence of unacceptable weight loss or toxicity Patients responding to either cyproheptadine or megestrol may continue treatment at the discretion of the treating physician
Patients are followed at 4 weeks
PROJECTED ACCRUAL A total of 70 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| SCUSF 0205 | OTHER | SunCoast CCOP Research Base | httpsreporternihgovquickSearchU10CA081920 |
| HLMCC-0205 | OTHER | None | None |
| U10CA081920 | NIH | None | None |