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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Northwestern University
ClinicalTrials.gov Identifier:
NCT00004914
First received: March 7, 2000
Last updated: May 31, 2012
Last verified: May 2012
  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
Anemia
Fatigue
Unspecified Adult Solid Tumor, Protocol Specific
Biological: epoetin alfa
Procedure: physical therapy
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: 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

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Study Start Date: January 2000
Study Completion Date: December 2001
Primary Completion Date: December 2001 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00004914

Locations
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States, 60611-3013
Sponsors and Collaborators
Northwestern University
Investigators
Study Chair: Jamie Hayden Von Roenn, MD Robert H. Lurie Cancer Center
  More Information

No publications provided

Responsible Party: Northwestern University
ClinicalTrials.gov Identifier: NCT00004914     History of Changes
Other Study ID Numbers: NU 98CC7, NU-98CC7, NCI-G00-1706
Study First Received: March 7, 2000
Last Updated: May 31, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Northwestern University:
unspecified adult solid tumor, protocol specific
anemia
fatigue

Additional relevant MeSH terms:
Anemia
Fatigue
Hematologic Diseases
Signs and Symptoms
Epoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 29, 2014