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The Effects of Cross Training on Fatigue and Pain Levels in Breast Cancer Survivors


N/A
18 Years
60 Years
Open (Enrolling)
Both
Breast Cancer, Cancer Survivor, Fatigue, Pain

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Trial Information

The Effects of Cross Training on Fatigue and Pain Levels in Breast Cancer Survivors


OBJECTIVES:

- Determine whether a moderate-intensity exercise program comprising cardiorespiratory
and resistance training of the legs, back, abdominal, trunk, and arm musculature vs a
control group attenuates fatigue and pain in breast cancer survivors.

- Determine whether this exercise program will significantly improve the quality of life
of these patients.

- Determine whether this exercise program can significantly reduce the number of days of
absenteeism from work in these patients.

- Determine whether this exercise program can significantly attenuate mood disturbances
in these patients.

OUTLINE: This is a randomized, controlled, pilot study. Patients are randomized to 1 of 2
treatment arms.

- Arm I (exercise program): Patients participate in an exercise program comprising
cardiorespiratory (walking on a treadmill) and resistance training for 1 hour, 3 times
weekly for 12 weeks.

- Arm II (control): Patients undergo no intervention. In both arms, patients complete
questionnaires regarding general health, mood, work attendance, and physical activity
before the start of study treatment and then every 3 weeks for 12 weeks. Patients also
complete a 7-day physical activity diary and sleep diary every 3 weeks.

PROJECTED ACCRUAL: A total of 54 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Breast cancer survivor

- Received adjuvant chemotherapy or radiotherapy for breast cancer only

- Must have completed treatment 2-6 months ago

- Hormone receptor status not specified

PATIENT CHARACTERISTICS:

- Female

- Menopausal status not specified

- Hemoglobin ≥ 11 g/dL

- Able to read English

- No high-risk for cardiovascular problems during exercise, including any of the
following:

- Unstable heart disease

- Unstable angina

- Chronic respiratory disease

- Dizziness

- Uncontrolled hypertension

- No severe respiratory disease requiring oxygen therapy

- No history of anorexia (body mass index [BMI] < 18.5) or severe obesity (BMI > 35)

- No history of multiple cancers

- No shortness of breath or hypotension

- No sudden swelling of the ankles, hands or face

- No palpitations or arrhythmias

- No persistent and intolerable pain

- No major acute illness (e.g., fever or respiratory infection)

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

Type of Study:

Interventional

Study Design:

Allocation: Randomized

Principal Investigator

Melanie Poudevigne, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Clayton State University

Authority:

Unspecified

Study ID:

CDR0000466676

NCT ID:

NCT00336089

Start Date:

January 2006

Completion Date:

Related Keywords:

  • Breast Cancer
  • Cancer Survivor
  • Fatigue
  • Pain
  • fatigue
  • pain
  • cancer survivor
  • breast cancer in situ
  • inflammatory breast cancer
  • stage IA breast cancer
  • stage IB breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • stage IV breast cancer
  • recurrent breast cancer
  • Breast Neoplasms
  • Fatigue

Name

Location

Saint Joseph's Hospital of AtlantaAtlanta, Georgia  30342-1701
Clayton State UniversityMorrow, Georgia  30260-0285