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| Sponsors and Collaborators: |
Robert H. Lurie Cancer Center National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00004914 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer-Related Problem/Condition Fatigue Unspecified Adult Solid Tumor, Protocol Specific |
Biological: epoetin alfa Procedure: physical therapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Supportive Care |
| Official Title: | A Phase II Trial of Progressive Resistance Training (PRT) Plus Procrit for the Treatment of Anemia-Related Fatigue in Cancer Patients |
| Study Start Date: | January 2000 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Diagnosis of nonmyeloid malignancy with cancer related fatigue Anemia (hemoglobin less than 10 g/dL) No clinical or radiographic evidence of lytic bone metastases
PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-2 Life expectancy: Greater than 4 months Hematopoietic: See Disease Characteristics Hepatic: Not specified Renal: Not specified Other: No dementia or evidence of mental incompetence No physical handicap precluding aerobic or resistance exercise No clinical abnormality that would render exercise a risk HIV negative No contraindications to epoetin alfa Not pregnant or nursing Negative pregnancy test
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 8 weeks since prior epoetin alfa Chemotherapy: Concurrent chemotherapy allowed Endocrine therapy:
Not specified Radiotherapy: Concurrent radiotherapy allowed Surgery: Not specified Other: Concurrent anticancer therapy allowed At least 1 month since prior strength training of greater than 3 hours a week
Contacts and Locations| United States, Illinois | |
| Robert H. Lurie Comprehensive Cancer Center, Northwestern University | |
| Chicago, Illinois, United States, 60611-3013 | |
| Study Chair: | Jamie Hayden Von Roenn, MD | Robert H. Lurie Cancer Center |
More Information
| Study ID Numbers: | CDR0000067594, NU-98CC7, NCI-G00-1706 |
| Study First Received: | March 7, 2000 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00004914 History of Changes |
| Health Authority: | United States: Federal Government |
|
unspecified adult solid tumor, protocol specific anemia fatigue |
|
Epoetin Alfa Signs and Symptoms Fatigue Hematinics Anemia |
|
Epoetin Alfa Signs and Symptoms Fatigue Hematinics |
Therapeutic Uses Hematologic Agents Pharmacologic Actions |
