Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Effects of Exercise Intervention on Insulin Levels in Breast Cancer Survivors

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jennifer A. Ligibel, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00153894
First received: September 8, 2005
Last updated: October 9, 2013
Last verified: October 2013

September 8, 2005
October 9, 2013
December 2003
June 2006   (final data collection date for primary outcome measure)
To determine whether strength and endurance training will lower fasting insulin levels in a group of breast cancer survivors. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
To determine whether strength and endurance training will lower fasting insulin levels in a group of breast cancer survivors.
Complete list of historical versions of study NCT00153894 on ClinicalTrials.gov Archive Site
  • To assess the compliance of a group of breast cancer survivors to a 16 week exercise intervention [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • to determine whether a combination strength and endurance training intervention can increase strength and endurance by 25% over a 16 week training period [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • to evaluate the impact of an exercise intervention on weight, waist-hip ratio and body composition in breast cancer survivors. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • To assess the compliance of a group of breast cancer survivors to a 16 week exercise intervention
  • to determine whether a combination strength and endurance training intervention can increase strength and endurance by 25% over a 16 week training period
  • to evaluate the impact of an exercise intervention on weight, waist-hip ratio and body composition in breast cancer survivors.
Not Provided
Not Provided
 
Effects of Exercise Intervention on Insulin Levels in Breast Cancer Survivors
Pilot Study of the Effects of an Exercise Intervention on Insulin Levels in Breast Cancer Survivors

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.

  • 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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Breast Cancer
  • Behavioral: Strength training
    One-on-One training with a personal trainer for 50 minutes twice a week using Nautilus machines for 16 weeks.
  • Behavioral: Endurance training
    Cardiovascular training at home for 30 minutes three times per week for 16 weeks.
  • Active Comparator: Group A
    Immediate Exercise
    Interventions:
    • Behavioral: Strength training
    • Behavioral: Endurance training
  • Active Comparator: Group B
    Delayed Exercise (delay by 16 weeks)
    Interventions:
    • Behavioral: Strength training
    • Behavioral: Endurance training

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
June 2014
June 2006   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00153894
03-327
No
Jennifer A. Ligibel, MD, Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
Not Provided
Principal Investigator: Jennifer Ligibel, MD Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP