Ignite Creation Date:
2024-05-05 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00376675
Status:
COMPLETED
Last Update Posted:
2016-08-01
First Post:
2006-09-13
Brief Title:
Methylphenidate in Treating Patients With Fatigue Caused by Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Long Acting Methylphenidate Concerta for Cancer-Related Fatigue A Phase III Randomized Double-Blind Placebo Controlled Study
Status:
COMPLETED
Status Verified Date:
2016-07
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 Methylphenidate may help relieve fatigue caused by cancer It is not yet known whether methylphenidate is more effective than a placebo in relieving fatigue and improving quality of life in patients with cancer
PURPOSE This randomized phase III trial is studying methylphenidate to see how well it works in treating patients with fatigue caused by cancer
PURPOSE This randomized phase III trial is studying methylphenidate to see how well it works in treating patients with fatigue caused by cancer
Detailed Description:
OBJECTIVES
Primary
Test the efficacy of long-acting methylphenidate in patients with cancer-related fatigue as measured using an item of the Brief Fatigue Inventory
Secondary
Evaluate the tolerability and adverse events associated with this drug in these patients
Study the effect of this drug on quality of life QOL-related variables vitality sleep quality overall QOL QOL domains other fatigue measures and perceived treatment efficacy in these patients
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to disease stage 0 I or II vs III or IV level of fatigue at baseline 4-7 vs 8-10 concurrent biological therapy yes vs no concurrent chemotherapy yes vs no and concurrent radiotherapy yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral methylphenidate daily on days 1-28
Arm II Patients receive oral placebo daily on days 1-28
Patients in both arms complete questionnaires to assess their symptoms of fatigue overall mood quality of life sleep quality and adverse effects from treatment at baseline and once weekly for 4 weeks Patients also complete a Symptom Experience Diary
McNeil Consumer Specialty Pharmaceuticals provided medication support for NCCTG N05C7
PROJECTED ACCRUAL A total of 140 patients will be accrued for this study
Primary
Test the efficacy of long-acting methylphenidate in patients with cancer-related fatigue as measured using an item of the Brief Fatigue Inventory
Secondary
Evaluate the tolerability and adverse events associated with this drug in these patients
Study the effect of this drug on quality of life QOL-related variables vitality sleep quality overall QOL QOL domains other fatigue measures and perceived treatment efficacy in these patients
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to disease stage 0 I or II vs III or IV level of fatigue at baseline 4-7 vs 8-10 concurrent biological therapy yes vs no concurrent chemotherapy yes vs no and concurrent radiotherapy yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral methylphenidate daily on days 1-28
Arm II Patients receive oral placebo daily on days 1-28
Patients in both arms complete questionnaires to assess their symptoms of fatigue overall mood quality of life sleep quality and adverse effects from treatment at baseline and once weekly for 4 weeks Patients also complete a Symptom Experience Diary
McNeil Consumer Specialty Pharmaceuticals provided medication support for NCCTG N05C7
PROJECTED ACCRUAL A total of 140 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 |
|---|---|---|---|
| CDR0000495148 | REGISTRY | PDQ Physician Data Query | None |
| NCI-2012-02701 | REGISTRY | None | None |