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Randomized Trial of Optimal Type of Aerobic Training in Breast Cancer


Phase 1/Phase 2
21 Years
90 Years
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Randomized Trial of Optimal Type of Aerobic Training in Breast Cancer


In this study we want to compare the effect of high-intensity to moderate-intensity aerobic
training, relative to attention-control, on peak oxygen consumption.

This study will include women who are at least 21 years old, an interval of no longer than 5
years following completion of primary therapy, life expectancy of greater than 6 months,
sedentary, willingness to be randomized, and signed consent form prior to all study
assessments.


Inclusion Criteria:



- At least 21 years old

- An interval of at least 1 year following completion of primary therapy

- An interval of no longer than 5 years following completion of primary therapy.

- Estimated life expectancy > 6 months

- Ability to read and understand English

- Primary attending oncologist approval

- Sedentary

- Willingness to be randomized

- Signed informed consent form prior to initiation of study-related procedures

Exclusion Criteria:

- Presence of a concurrent, actively treated other malignancy or history of other
malignancy treated within the past three years.

- Presence of metastatic disease

- No contraindication to a maximal exercise test or aerobic training and defined by the
American Thoracic Society

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care

Outcome Measure:

To compare the effect of high-intensity to moderate-intensity aerobic training, relative to attention-control, on peak oxygen consumption.

Outcome Description:

VO2 or peak oxygen consumption will be measured at 3 time-points. Baseline, mid-point (8 weeks), and post-intervention (16 weeks).

Outcome Time Frame:

3 time-points

Safety Issue:

Yes

Principal Investigator

Lee W Jones, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University

Authority:

United States: Institutional Review Board

Study ID:

Pro00022294

NCT ID:

NCT01186367

Start Date:

August 2010

Completion Date:

March 2015

Related Keywords:

  • Breast Cancer
  • breast cancer
  • Breast Neoplasms

Name

Location
Duke Center for Living Durham, North Carolina  27710