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Home > "E" Clinical Trials Conditions > Exercise Plus Epoetin Alfa in Treating Cancer Patients Who Have Anemia-Related Fatigue

Exercise Plus Epoetin Alfa in Treating Cancer Patients Who Have Anemia-Related Fatigue



Exercise Plus Epoetin Alfa in Treating Cancer Patients Who Have Anemia-Related Fatigue

For Condition: unspecified adult solid tumor, protocol specific,Anemia,Fatigue
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Robert H. Lurie Cancer Center
Synopsis: 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.
Details: 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. PROTOCOL 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:
Study Type:
  Interventional, Educational/Counseling/Training
Minimum Age/Maximum Age: 18 Years/
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --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 --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 --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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
JamieVon Roenn,  Study Chair,  Robert H. Lurie Cancer Center

Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago,  Illinois,  60611-3013
United States
 


Additional Information:
Study ID Numbers:
  CDR0000067594;  NU-98CC7,NCI-G00-1706
Study Start Date: January 2000
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004914

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