NCT00153894

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Dec 2003

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

June 27, 2016

Status Verified

June 1, 2016

Enrollment Period

2.5 years

First QC Date

September 8, 2005

Last Update Submit

June 24, 2016

Conditions

Breast Cancer

Keywords

Breast cancer survivorInsulin levelsexercise regimenendurance trainingstrength training

Outcome Measures

Primary Outcomes (1)

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

    3 years

Secondary Outcomes (3)

  • To assess the compliance of a group of breast cancer survivors to a 16 week exercise intervention

    3 years

  • to determine whether a combination strength and endurance training intervention can increase strength and endurance by 25% over a 16 week training period

    3 years

  • to evaluate the impact of an exercise intervention on weight, waist-hip ratio and body composition in breast cancer survivors.

    3 years

Study Arms (2)

Group A

ACTIVE COMPARATOR

Immediate Exercise

Behavioral: Strength trainingBehavioral: Endurance training

Group B

ACTIVE COMPARATOR

Delayed Exercise (delay by 16 weeks)

Behavioral: Strength trainingBehavioral: Endurance training

Interventions

Strength trainingBEHAVIORAL

One-on-One training with a personal trainer for 50 minutes twice a week using Nautilus machines for 16 weeks.

Group AGroup B
Endurance trainingBEHAVIORAL

Cardiovascular training at home for 30 minutes three times per week for 16 weeks.

Group AGroup B

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Related Publications (2)

  • 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.

    PMID: 19434504RESULT

  • 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.

    PMID: 18281663RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Resistance TrainingEndurance Training

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jennifer Ligibel, MD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

December 1, 2003

Primary Completion

June 1, 2006

Study Completion

February 1, 2008

Last Updated

June 27, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)