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

NCT01896050 | Completed Results

• 1 other identifier: UMCC 2009.029
• Study Type: observational
• Target: 115
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer; Arthralgia; Obesity

Keywords

Joint pain; Grip strength; Hormone receptor positive breast cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Effect of Medication on Change in Grip Strength

  baseline and 12 months

• Association Between Baseline Body Mass Index and Discontinuation of Aromatase Inhibitor Therapy Within the First 12 Months

  baseline and 12 months

Study Arms (2)

AI therapy

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

Drug: anastrozole, letrozole, exemestane

Tamoxifen

Subjects who started treatment with tamoxifen

Drug: Tamoxifen

Interventions

anastrozole, letrozole, exemestane DRUG

Patients were treated with one of the listed anti-hormonal medications for up to one year

Also known as: Arimidex, Femara, Aromasin

AI therapy

Tamoxifen DRUG

Patients were treated with tamoxifen for up to one year

Also known as: Novaldex

Tamoxifen

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead

Study Sites (1)

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood is being collected at baseline for DNA extraction. Serum is being collected at baseline and after 3, 6, and 12 months.

MeSH Terms

Conditions

Breast Neoplasms; Arthralgia; Obesity

Interventions

Anastrozole; Letrozole; exemestane; Tamoxifen

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; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Norah Lynn Henry, MD
• Organization: University of Michigan Comprehensive Cancer Center

norahh@med.umich.edu

734-936-4991

Study Officials

• Norah L Henry, MD, PhD

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 5, 2013
• First Posted: July 11, 2013
• Study Start: September 1, 2009
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: June 28, 2016
• Results First Posted: May 12, 2016

Record last verified: 2016-05

Locations

US (1)