Clinical trial NCT00577096: Effects of Exercise in Combination With Epoetin Alfa
Official title: Effects of Exercise in Combination With Epoetin Alfa During High-Dose Chemotherapy and Autologous Peripheral Blood Stem Cell Transplantation for Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Myeloma
Keywords: multiple myeloma
polysomnography
quality of life
exercise
Lead sponsor: University of Arkansas
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Ortho Biotech Clinical Affairs, L.L.C.
First posted: 2007-12-19
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the study was to determine the effect of Epoetin alfa therapy (short term versus long term) with and without a home-based individualized exercise program that incorporated aerobic and strength resistance training for patients being treated with high-dose chemotherapy and autologous peripheral bloodstem cell transplantation (PBSC T) for multiple myeloma. The endpoints for the study included the number of attempts at and total number of days of stem cell collection, number of RBC and platelet transfusions during the transplantation period, time-to-recovery after transplantation, and response to intensive therapy for multiple myeloma.


Eligibility criteria: Inclusion Criteria:

* Those who were not at high risk for impending pathologic fracture or cord compression, as determined by magnetic resonance imaging and other radiology reports and physician assessments,and enrolled in Total Therapy treatment protocols were invited to participate in the study.

Exclusion Criteria:

Patients were excluded if they showed any of the following attributes/conditions:

* Inability to understand the intent of the study
* Current diagnosis with a major psychiatric illness
* Presence of microcytic or macrocytic anemia
* Uncontrolled hypertension
* Red cell transfusions within 2 weeks; and
* Recombinant epoetin alfa within 8 weeks of study enrollment.

Primary outcomes:
measure: Number of Red Blood Cell Transfusions Needed to Maintain Hemoglobin Levels (Short Term)
timeFrame: up to 15 weeks
measure: Number of Red Blood Cell Transfusions Needed to Maintain Hemoglobin Levels (Long Term)
timeFrame: up to 30 weeks
measure: Number of Platelet Transfusions Needed to Maintain Adequate Number of Platelets.(Short Term)
timeFrame: up to 15 weeks
measure: Number of Platelet Transfusions Needed to Maintain Adequate Number of Platelets. (Long Term)
timeFrame: up to 30 weeks
measure: Number of Stem Cell Collection Attempts (Short Term)
timeFrame: up to 15 weeks
measure: Number of Stem Cell Collection Attempts (Long Term)
timeFrame: up to 30 weeks
measure: Total Number of Days of Stem Cell Collection (Short Term)
timeFrame: up to 15 weeks
measure: Total Number of Days of Stem Cell Collection (Long Term)
timeFrame: up to 30 weeks
Secondary outcomes:
measure: Hemoglobin Levels Before Chemotherapy and During Transplantation Period (Short Term)
timeFrame: up to 15 weeks
measure: Hemoglobin Levels Before Chemotherapy and During Transplantation Period (Long Term)
timeFrame: up to 30 weeks
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: University of Oklahoma
name: Sharon K Coon
role: STUDY_DIRECTOR
References: