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Pilot Study of the Effects of an Exercise Intervention on Insulin Levels in Breast Cancer Survivors

18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

Pilot Study of the Effects of an Exercise Intervention on Insulin Levels in Breast Cancer Survivors

- All women taking part in this study will take part in an exercise program. Group A
will start exercising immediately and Group B wil have a delay period of 16 weeks
before starting to exercise so investigators can look at the changes in insulin levels
that occur in a women who is not exercising.

- The exercise program will be made up of two parts: strength (or weight) training and
cardiovascular exercise. The strength exercise will take place at a gym close to
Dana-Farber Cancer Institute. Patients will work one on one with a personal trainer
twice a week for 50 minutes. During each of these sessions, participants will have a
brief warm up period and then will perform a series of Nautilus machine-based exercises
under the guidance of the personal trainer. The goal of each session will be to
increase strength by increasing weight lifted and repetitions.

- Participants will also do cardiovascular exercises on their own at home. Each
participant will receive a pedometer and heart rate monitor. Women will be advised to
exercise for at least 30 minutes three times per week on their own and will keep a
journal recording how long and how intensively they exercised. Participants will
receive weekly phone calls from the project manager to review the cardiovascular

- Women will undergo a series of measurements before and after the 16 week exercise
intervention. They will be asked to fast for 12 hours prior to each of these
measurement sessions. Measurements will include blood testing for insulin and glucose
levels. Women will also be weighed, height will be measured, body composition will be
computed using a noninvasive bioelectric impedance monitor, and hip/waist measurements
will be taken. Group A participants will undergo testing at the time of enrolling in
the study and after 16 weeks of exercise. Group B participants will undergo these
tests after enrollment, after the 16 week waiting period and at the end of the exercise

- Participants will also complete two surveys by mail, 3 months and 9 months after
completing the exercise portion of the protocol.

Inclusion Criteria:

- History of pathologically confirmed stage I-IIIa invasive breast cancer

- Adjuvant chemotherapy and/or radiation must be completed at least 3 months prior to

- Body mass index > 25 and/or a body composition analysis of >30

Exclusion Criteria:

- Patients taking herceptin

- Evidence of residual or distant disease

- Use of any medication expected to affect insulin levels

- Baseline exercise of more than 20 minutes two times per week

- Active malignancy

- Diabetes mellitus

- Heart disease or uncontrolled hypertension

- Presence of any condition that might be expected to impact a participant's ability to
perform physical activity

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

To determine whether strength and endurance training will lower fasting insulin levels in a group of breast cancer survivors.

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Jennifer Ligibel, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

December 2003

Completion Date:

September 2012

Related Keywords:

  • Breast Cancer
  • Breast cancer survivor
  • Insulin levels
  • exercise regimen
  • endurance training
  • strength training
  • Breast Neoplasms



Dana Farber Cancer Institute Boston, Massachusetts  02115