Clinical trial NCT00153894: Effects of Exercise Intervention on Insulin Levels in Breast Cancer Survivors
Official title: Pilot Study of the Effects of an Exercise Intervention on Insulin Levels in Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast cancer survivor
Insulin levels
exercise regimen
endurance training
strength training
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether an exercise program comprised of strength and endurance training will lower fasting insulin levels in a group of breast cancer survivors. Insulin may be involved in the risk of breast cancer recurrence.

Detailed description: * 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 exercise.
* 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 program.
* Participants will also complete two surveys by mail, 3 months and 9 months after completing the exercise portion of the protocol.

Eligibility criteria: 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 enrollment
* 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

Primary outcomes:
measure: To determine whether strength and endurance training will lower fasting insulin levels in a group of breast cancer survivors.
timeFrame: 3 years
Secondary outcomes:
measure: To assess the compliance of a group of breast cancer survivors to a 16 week exercise intervention
timeFrame: 3 years
measure: to determine whether a combination strength and endurance training intervention can increase strength and endurance by 25% over a 16 week training period
timeFrame: 3 years
measure: to evaluate the impact of an exercise intervention on weight, waist-hip ratio and body composition in breast cancer survivors.
timeFrame: 3 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Jennifer Ligibel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ligibel JA, Giobbie-Hurder A, Olenczuk D, Campbell N, Salinardi T, Winer EP, Mantzoros CS. Impact of a mixed strength and endurance exercise intervention on levels of adiponectin, high molecular weight adiponectin and leptin in breast cancer survivors. Cancer Causes Control. 2009 Oct;20(8):1523-8. doi: 10.1007/s10552-009-9358-3. Epub 2009 May 13.
citation: Ligibel JA, Campbell N, Partridge A, Chen WY, Salinardi T, Chen H, Adloff K, Keshaviah A, Winer EP. Impact of a mixed strength and endurance exercise intervention on insulin levels in breast cancer survivors. J Clin Oncol. 2008 Feb 20;26(6):907-12. doi: 10.1200/JCO.2007.12.7357.