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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
  Purpose

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.


Condition Intervention
Breast Cancer
Behavioral: Strength training
Behavioral: Endurance training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Pilot Study of the Effects of an Exercise Intervention on Insulin Levels in Breast Cancer Survivors

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 100
Study Start Date: December 2003
Estimated Study Completion Date: June 2014
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group A
Immediate Exercise
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 B
Delayed Exercise (delay by 16 weeks)
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00153894

Locations
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
Principal Investigator: Jennifer Ligibel, MD Dana-Farber Cancer Institute
  More Information

Publications:
Responsible Party: Jennifer A. Ligibel, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00153894     History of Changes
Other Study ID Numbers: 03-327
Study First Received: September 8, 2005
Last Updated: October 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
Breast cancer survivor
Insulin levels
exercise regimen
endurance training
strength training

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Insulin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 27, 2014