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A Phase II Trial of Progressive Resistance Training (PRT) Plus Procrit for the Treatment of Anemia-Related Fatigue in Cancer Patients


Phase 2
18 Years
N/A
Not Enrolling
Both
Anemia, Fatigue, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

A Phase II Trial of Progressive Resistance Training (PRT) Plus Procrit for the Treatment of Anemia-Related Fatigue in Cancer Patients


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Supportive Care

Principal Investigator

Jamie Hayden Von Roenn, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Robert H. Lurie Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

NU 98CC7

NCT ID:

NCT00004914

Start Date:

January 2000

Completion Date:

December 2001

Related Keywords:

  • Anemia
  • Fatigue
  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • anemia
  • fatigue
  • Anemia
  • Fatigue

Name

Location
Robert H. Lurie Comprehensive Cancer Center, Northwestern University Chicago, Illinois  60611