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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01223833

Acronym

LOGRIBMET

Enrollment

296

Registered

2010-10-19

Start date

2009-04-30

Completion date

2013-06-30

Last updated

2013-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthralgia, Breast Cancer

Keywords

breast cancer, postmenopausal, aromatase inhibitors, tamoxifen, arthralgia, IGF-I, BMI, grip strength

Brief summary

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.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
To assess the effect of BMI on loss of grip strength measured by a modified sphygmomanometer with baseline, month 3, month 6 and month 12 measurements.	1 year	measurements occur at baseline, 3 months, 6 months and 12 months

Secondary

Measure	Time frame	Description
IGF-I, GH and IGFBP-3 levels	1 year	Serum levels of IGF-I, GH and IGFBP-3 will be measured at baseline, 3, 6 and 12 months after start of treatment.

Countries

Belgium

Outcome results