A Prospective Assessment of Loss of Grip Strength by Baseline BMI in Breast Cancer Patients Receiving Adjuvant Aromatase Inhibitors and Tamoxifen (LOGRIBMET)

Universitaire Ziekenhuizen KU Leuven

Status: Completed

Conditions: Breast Cancer; Arthralgia

Study type: Observational

Funder types: Other

Identifiers

NCT01223833

S51575

Details and patient eligibility

About

The Logribmet study is a prospective study that evaluate grip strength changes in both hands of postmenopausal women with breast cancer receiving treatment with tamoxifen or an aromatase inhibitor. Patients included in the study will undergo a grip strength measurement and receive a rheumatological questionnaire prior to the start of treatment, then at 3 and 6 months and at year 1 into therapy. Furthermore, BMI will be measured to assess if BMI is a predictor for the decrease in grip strength.

IGF-I, GH and IGFBP-3 serum levels will also be measured at all time points.

Enrollment: 296 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with early breast cancer who are scheduled to receive endocrine therapy with tamoxifen or any of the third-generation aromatase inhibitors, anastrozole, letrozole or exemestane.
2. No major rheumatological disorders such as severe rheumatoid arthritis.
3. Patients must have provided informed consent for participation in this study.

Exclusion criteria

1. Concomitant endocrine therapy for breast cancer.
2. Concomitant intake of sex hormone containing drugs such as hormone replacement therapy.

Trial design

296 participants in 2 patient groups

tamoxifen

Description:

100 postmenopausal women with early breast cancer treated with tamoxifen in the adjuvant setting

aromatase inhibitors

Description:

200 postmenopausal women with early breast cancer treated with an aromatase inhibitor in the adjuvant setting