Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00031798
Status:
TERMINATED
Last Update Posted:
2021-09-09
First Post:
2002-03-08
Brief Title:
Methylphenidate to Improve Quality of Life in Patients Undergoing Radiation Therapy for Brain Tumors
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
A Phase III Double-Blind Prospective Randomized Clinical Trial of the Effect of D-threo-methylphenidate HCl d-MPH on Quality of Life in Brain Tumor Patients Receiving Radiation Therapy
Status:
TERMINATED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
low accrual loss of funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Methylphenidate may decrease side effects of radiation therapy It is not yet known if methylphenidate is effective in improving quality of life in patients with primary or metastatic brain tumors
PURPOSE Randomized phase III trial to determine the effectiveness of methylphenidate in improving quality of life in patients who have brain tumors and are undergoing radiation therapy
PURPOSE Randomized phase III trial to determine the effectiveness of methylphenidate in improving quality of life in patients who have brain tumors and are undergoing radiation therapy
Detailed Description:
OBJECTIVES
Determine the effect of d-methylphenidate on fatigue in patients receiving radiotherapy for primary or metastatic brain tumors
Determine the effect of this drug on the quality of life of these patients
Determine the effect of this drug on depression in these patients
Determine the effect of this drug on global neurocognitive function including attention and concentration memory language visuospatial skills and executive function in these patients
OUTLINE This is a randomized placebo-controlled double-blind multicenter study Patients are stratified by tumor type primary vs metastatic treatment radiotherapy vs radiotherapy and chemotherapy and Karnofsky performance status 70 or 80 vs 90 or 100 Patients are randomized to one of two treatment arms
All patients undergo radiotherapy over weeks 1-4
Arm I Patients receive oral d-methylphenidate twice daily on weeks 1-12
Arm II Patients receive oral placebo twice daily on weeks 1-12 In both arms quality of life is assessed at baseline at the end of radiotherapy and at 4 8 and 12 weeks after radiotherapy
Patients are followed at 4 weeks
PROJECTED ACCRUAL A total of 200 patients 100 per treatment arm will be accrued for this study within 18 months
Determine the effect of d-methylphenidate on fatigue in patients receiving radiotherapy for primary or metastatic brain tumors
Determine the effect of this drug on the quality of life of these patients
Determine the effect of this drug on depression in these patients
Determine the effect of this drug on global neurocognitive function including attention and concentration memory language visuospatial skills and executive function in these patients
OUTLINE This is a randomized placebo-controlled double-blind multicenter study Patients are stratified by tumor type primary vs metastatic treatment radiotherapy vs radiotherapy and chemotherapy and Karnofsky performance status 70 or 80 vs 90 or 100 Patients are randomized to one of two treatment arms
All patients undergo radiotherapy over weeks 1-4
Arm I Patients receive oral d-methylphenidate twice daily on weeks 1-12
Arm II Patients receive oral placebo twice daily on weeks 1-12 In both arms quality of life is assessed at baseline at the end of radiotherapy and at 4 8 and 12 weeks after radiotherapy
Patients are followed at 4 weeks
PROJECTED ACCRUAL A total of 200 patients 100 per treatment arm will be accrued for this study within 18 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| NCI-P02-0211 | None | None | None |
| CCCWFU-97600 | None | None | None |