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

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Breast Cancer; Arthralgia
• Intervention / Treatment: Drug: anastrozole, letrozole, exemestane; Drug: Tamoxifen

• Study Type: Observational
• Enrollment (Actual): 115

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
AI therapy; Subjects who started treatment with any of the three aromatase inhibitor (AI) medications	Drug: anastrozole, letrozole, exemestane; Patients were treated with one of the listed anti-hormonal medications for up to one year; Other Names: Arimidex, Femara, Aromasin
Tamoxifen; Subjects who started treatment with tamoxifen	Drug: Tamoxifen; Patients were treated with tamoxifen for up to one year; Other Names: Novaldex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of Change in Body Mass Index on Change in Grip Strength With Aromatase Inhibitor Therapy	Change in BMI between baseline and 12 months of endocrine therapy	baseline and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of Medication on Change in Grip Strength	Effect of either aromatase inhibitor or tamoxifen therapy on change in grip strength between baseline and 12 months	baseline and 12 months
Association Between Baseline Body Mass Index and Discontinuation of Aromatase Inhibitor Therapy Within the First 12 Months	Associations between baseline BMI and whether or not aromatase inhibitor-treated patients discontinued treatment by 12 months. In the original statistical analysis plan, it was only intended to examine the association with aromatase inhibitor-treated patients, and not tamoxifen-treated patients. The numbers below reflect the number of patients in each group who discontinued initial endocrine therapy within the first 12 months of treatment	baseline and 12 months

Collaborators and Investigators

• Sponsor: University of Michigan Rogel Cancer Center

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: July 5, 2013
• First Submitted That Met QC Criteria: July 5, 2013
• First Posted (Estimate): July 11, 2013

Study Record Updates

• Last Update Posted (Estimate): June 28, 2016
• Last Update Submitted That Met QC Criteria: May 25, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Joint pain; Hormone receptor positive breast cancer; Grip strength
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Pain; Neurologic Manifestations; Breast Diseases; Joint Diseases; Musculoskeletal Diseases; Breast Neoplasms; Arthralgia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Hormone Antagonists; Bone Density Conservation Agents; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Estrogen Antagonists; Selective Estrogen Receptor Modulators; Estrogen Receptor Modulators; Letrozole; Tamoxifen; Anastrozole; Exemestane
• Other Study ID Numbers: UMCC 2009.029