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

NCT01223833 | Completed

• 1 other identifier: S51575
• Study Type: observational
• Target: 296
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Arthralgia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  measurements occur at baseline, 3 months, 6 months and 12 months

  1 year

Secondary Outcomes (1)

• IGF-I, GH and IGFBP-3 levels

  1 year

Study Arms (2)

tamoxifen

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

aromatase inhibitors

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Postmenopausal early breast cancer patients scheduled to start adjuvant hormonal therapy with any of the third generation aromatase inhibitors or tamoxifen in University Hospitals Leuven.

You may qualify if:

• 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.
• No major rheumatological disorders such as severe rheumatoid arthritis.
• Patients must have provided informed consent for participation in this study.

You may not qualify if:

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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

University Hospitals Leuven

Leuven, 3000, Belgium

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Breast Neoplasms; Arthralgia

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Patrick Neven, MD PhD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2010
• First Posted: October 19, 2010
• Study Start: April 1, 2009
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: July 25, 2013

Record last verified: 2010-11

Locations

BE (1)