Clinical trial NCT01896050: Loss of Grip Strength, BMI, and Adjuvant Endocrine Therapy Breast Cancer
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Arthralgia
Obesity
Keywords: Joint pain
Grip strength
Hormone receptor positive breast cancer
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
First posted: 2013-07-11
Enrollment: 115
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Postmenopausal women with hormone receptor positive breast cancer who are initiating therapy with either an aromatase inhibitor or tamoxifen.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Effect of Change in Body Mass Index on Change in Grip Strength With Aromatase Inhibitor Therapy
timeFrame: baseline and 12 months
Secondary outcomes:
measure: Effect of Medication on Change in Grip Strength
timeFrame: baseline and 12 months
measure: Association Between Baseline Body Mass Index and Discontinuation of Aromatase Inhibitor Therapy Within the First 12 Months
timeFrame: baseline and 12 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center
state: Michigan
Study officials:
affiliation: University of Michigan Rogel Cancer Center
name: Norah L Henry, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: