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Clinical Trials/NCT01896050
NCT01896050CompletedNot Applicable

A Prospective Assessment of Loss of Grip Strength by Baseline BMI in Breast Cancer Patients Receiving Adjuvant Third-generation Aromatase Inhibitors and Tamoxifen

University of Michigan Rogel Cancer Center1 site in 1 country115 target enrollmentStarted: September 2009Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
115
Locations
1
Primary Endpoint
Effect of Change in Body Mass Index on Change in Grip Strength With Aromatase Inhibitor Therapy

Study Overview

Brief Summary

Early stage hormone receptor positive breast cancer is typically treated with adjuvant endocrine therapy in order to decrease risk of breast cancer recurrence and to improve overall survival from the disease. Typical agents used for treatment include tamoxifen and the aromatase inhibitors. In postmenopausal women, aromatase inhibitor therapy is increasingly common because it is associated with fewer long-term serious toxicities compared to tamoxifen. However, aromatase inhibitors cause arthralgias in 40-50% of patients, which can influence adherence to therapy and can lead to treatment discontinuation in a minority of cases. The mechanism underlying development of this toxicity remains unclear, and predictors of who will develop these symptoms remain undefined. Initial reports suggest that grip strength decreases during aromatase inhibitor therapy, and that body-mass index may influence development of this symptom. Therefore, this longitudinal study has been developed to determine change in grip strength over time in women treated with aromatase inhibitors and tamoxifen, as well as to identify potential associations between change in grip strength and BMI. Patient self-reported symptoms will also be collected. A total of 115 women with early stage breast cancer who are initiating therapy with either an aromatase inhibitor or tamoxifen will be enrolled.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Stage 0-III breast cancer who are scheduled to receive endocrine therapy with tamoxifen or an aromatase inhibitor
  • All prior surgery and chemotherapy should be complete
  • Age 18 and above and postmenopausal

Exclusion Criteria

  • Major rheumatologic disorders
  • Concomitant sex hormone containing drugs or Leutinizing Hormone Releasing Hormone agonist therapy
  • For those subjects initiating treatment with an aromatase inhibitor, prior tamoxifen within 4 weeks of enrollment
  • For those subjects initiating treatment with tamoxifen, prior aromatase inhibitor within 4 weeks of enrollment

Arms & Interventions

AI therapy

Subjects who started treatment with any of the three aromatase inhibitor (AI) medications

Intervention: anastrozole, letrozole, exemestane (Drug)

Tamoxifen

Subjects who started treatment with tamoxifen

Intervention: Tamoxifen (Drug)

Outcomes

Primary Outcomes

Effect of Change in Body Mass Index on Change in Grip Strength With Aromatase Inhibitor Therapy

Time Frame: baseline and 12 months

Change in BMI between baseline and 12 months of endocrine therapy

Secondary Outcomes

  • Effect of Medication on Change in Grip Strength(baseline and 12 months)
  • Association Between Baseline Body Mass Index and Discontinuation of Aromatase Inhibitor Therapy Within the First 12 Months(baseline and 12 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Lynn Henry

Principal Investigator

University of Michigan Rogel Cancer Center

Study Sites (1)

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