Loss of Grip Strength, BMI, and Adjuvant Endocrine Therapy Breast Cancer

Breast Cancer Clinical Trial

— LOGRIBMET  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01896050
• Other study ID #: UMCC 2009.029
• Status: Completed
• Phase: N/A
• First received: July 5, 2013
• Last updated: December 8, 2014
• Start date: September 2009
• Est. completion date: August 2014

Study information

• Verified date: December 2014
• Source: University of Michigan Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthralgia
• Breast Cancer
• Breast Neoplasms
• Obesity

Locations

Country	Name	City	State
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of body mass index on change in grip strength with therapy	Association between BMI and change in grip strength between baseline and 12 months of either AI or tamoxifen therapy	12 months	No
Secondary	Effect of body mass index on change in grip strength over time	Associations between BMI and change in grip strength as assessed at baseline, 3, 6, and 12 months	12 months	No
Secondary	Effect of medication on change in grip strength	Effect of either aromatase inhibitor or tamoxifen therapy on change in grip strength between baseline and 12 months	12 months	No
Secondary	Effect of change in body mass index on change in grip strength with therapy	Associations between change in BMI between baseline and 12 months with change in grip strength between baseline and 12 months	12 months	No