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

University of Michigan Rogel Cancer Center

Status: Completed

Conditions: Breast Cancer; Obesity; Arthralgia

Treatments: Drug: Tamoxifen; Drug: anastrozole, letrozole, exemestane

Study type: Observational

Funder types: Other

Identifiers

NCT01896050

UMCC 2009.029

Details and patient eligibility

About

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.

Enrollment: 115 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

115 participants in 2 patient groups

AI therapy

Description:

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

Treatment:

Drug: anastrozole, letrozole, exemestane

Tamoxifen

Description:

Subjects who started treatment with tamoxifen

Treatment:

Drug: Tamoxifen