Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004914
Status:
COMPLETED
Last Update Posted:
2012-06-06
First Post:
2000-03-07
Brief Title:
Exercise Plus Epoetin Alfa in Treating Cancer Patients Who Have Anemia-Related Fatigue
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
A Phase II Trial of Progressive Resistance Training PRT Plus Procrit for the Treatment of Anemia-Related Fatigue in Cancer Patients
Status:
COMPLETED
Status Verified Date:
2012-05
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 Exercise may decrease anemia-related fatigue improve strength and build up lost muscle tissue Epoetin alfa may help improve cancer-related anemia energy levels and quality of life Exercise plus epoetin alfa may be effective treatment for anemia-related fatigue
PURPOSE Phase II trial to study the effectiveness of exercise plus epoetin alfa in treating cancer patients who have anemia-related fatigue
PURPOSE Phase II trial to study the effectiveness of exercise plus epoetin alfa in treating cancer patients who have anemia-related fatigue
Detailed Description:
OBJECTIVES I Determine the effect of progressive resistance training and epoetin alfa on lean body mass fatigue exercise tolerance functional capacity and total body weight in cancer patients with anemia related fatigue
OUTLINE Patients undergo progressive resistance training PRT consisting of 3 sets of 8 repetitions of concentric lifting and eccentric lowering exercises over 4-6 seconds each using bench press arm pull knee extension knee flexion and double leg press followed by 1-2 minutes of rest between sets Patients undergo warm up and cool down periods over 10 minutes prior to and following PRT Patients perform PRT 3 times a week for 12 weeks Patients also receive epoetin alfa subcutaneously once weekly over 4-12 weeks in the absence of unacceptable toxicity
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study over 15 months
OUTLINE Patients undergo progressive resistance training PRT consisting of 3 sets of 8 repetitions of concentric lifting and eccentric lowering exercises over 4-6 seconds each using bench press arm pull knee extension knee flexion and double leg press followed by 1-2 minutes of rest between sets Patients undergo warm up and cool down periods over 10 minutes prior to and following PRT Patients perform PRT 3 times a week for 12 weeks Patients also receive epoetin alfa subcutaneously once weekly over 4-12 weeks in the absence of unacceptable toxicity
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study over 15 months
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 |
|---|---|---|---|
| NCI-G00-1706 | None | None | None |
| NU-98CC7 | None | None | None |