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Prescriptive Exercise Intervention During Active Treatment for Early Stage Breast Cancer Patients: A Breast Cancer Rehabilitation & Exercise Laboratory

18 Years
Open (Enrolling)
Early Stage Breast Cancer (Stage 0-III)

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Trial Information

Prescriptive Exercise Intervention During Active Treatment for Early Stage Breast Cancer Patients: A Breast Cancer Rehabilitation & Exercise Laboratory

Patients (with stage 0 to stage III breast cancer)receiving chemotherapy, radiation or both
chemotherapy and radiation will be included in the study.Randomization will be stratified by
disease stage at diagnosis, treatment modalities planned, and hormonal status. Each patient
will have a weekly goal of 2000 calories burned and 18 MET-hours of exercise which can be
achieved in 4 to 7 hours of physical activity per week. Resistance training, using weight
machines and aerobic training using treadmills, elliptical trainers and stationary bicycles,
will be utilized in the intervention group. The control group will receive basic information
on physical activity but not be instructed. Any physical activity in this group will be
self-reported. Change in C-reactive protein will be the primary endpoint. Changes in other
laboratory values, DEXA measurements, and quality of life measurements will be secondary

Inclusion Criteria:

1. Consent to participate in study

2. Women aged 18 and older

3. Stage 0 to III breast cancer prior to any treatment and at time of diagnosis

4. Requires treatment that includes chemotherapy, radiation therapy or both chemotherapy
and radiation therapy

5. Adequate fitness to participate in a physical activity as assessed by the

6. Willing and able to participate in a prescribed exercise program

Exclusion Criteria:

1. Metastatic breast cancer (Stage IV)

2. Initiation of treatment regimen prior to enrollment

3. Treatment for breast cancer not requiring chemotherapy or radiation therapy

4. Patients who are pregnant (negative urine pregnancy test required at baseline to
determine eligibility in women of child bearing potential).

5. Currently lactating

6. Do not read, understand, or speak English

Eligible participants will not be included if they have:

1. known cardiac disease,

2. uncontrolled hypertension,

3. uncontrolled thyroid disease,

4. diabetes mellitus,

5. mental illness,

6. infection,

7. immune or endocrine abnormality,

8. body weight reduction I10% in past 6 months, and

9. positive exercise stress test.

10. Major surgery within last 6 months that requires exercise restriction

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Changes in CRP

Outcome Description:

The primary endpoint for this study change in C-reactive protein.

Safety Issue:


Principal Investigator

Karen Milligan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Nevada Cancer Institute


United States: Institutional Review Board

Study ID:

NVCI 10-09



Start Date:

July 2010

Completion Date:

Related Keywords:

  • Early Stage Breast Cancer (Stage 0-III)
  • Breast Cancer
  • Exercise
  • CRP
  • C-reactive protein
  • BMI
  • Nevada Cancer Institute
  • Rehabilitation
  • Prescriptive exercise
  • Physical Activity
  • DEXA
  • Obesity
  • lifestyle intervention
  • Early Stage Breast Cancer Patients (stage 0-III)
  • Breast Neoplasms



Nevada Cancer InstituteLas Vegas, Nevada  89135