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Exercise Plus Epoetin Alfa in Treating Cancer Patients Who Have Anemia-Related Fatigue
This study is ongoing, but not recruiting participants.
Study NCT00004914   Information provided by National Cancer Institute (NCI)
First Received: March 7, 2000   Last Updated: May 9, 2009   History of Changes

March 7, 2000
May 9, 2009
January 2000
 
 
 
Complete list of historical versions of study NCT00004914 on ClinicalTrials.gov Archive Site
 
 
 
Exercise Plus Epoetin Alfa in Treating Cancer Patients Who Have Anemia-Related Fatigue
A Phase II Trial of Progressive Resistance Training (PRT) Plus Procrit for the Treatment of Anemia-Related Fatigue in Cancer Patients

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.

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.

Phase II
Interventional
Supportive Care
  • Anemia
  • Fatigue
  • Unspecified Adult Solid Tumor, Protocol Specific
  • Biological: epoetin alfa
  • Procedure: physical therapy
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00004914
 
CDR0000067594, NU-98CC7, NCI-G00-1706
Robert H. Lurie Cancer Center
National Cancer Institute (NCI)
Study Chair: Jamie Hayden Von Roenn, MD Robert H. Lurie Cancer Center
National Cancer Institute (NCI)
January 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP