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

NCT00004914 | Completed Phase 2 DMC

• 3 other identifiers: NU 98CC7NU-98CC7NCI-G00-1706
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anemia; Fatigue; Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific; anemia; fatigue

Interventions

epoetin alfa BIOLOGICAL

physical therapy PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Northwestern University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

MeSH Terms

Conditions

Anemia; Fatigue

Interventions

Epoetin Alfa; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Therapeutics; Rehabilitation

Study Officials

• Jamie Hayden Von Roenn, MD

  Robert H. Lurie Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: SUPPORTIVE CARE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2000
• First Posted: March 4, 2004
• Study Start: January 1, 2000
• Primary Completion: December 1, 2001
• Study Completion: December 1, 2001
• Last Updated: June 6, 2012

Record last verified: 2012-05

Locations

US (1)