Effect of Aromatase Inhibitors on Ultrasonographic Measurements and Static and Dynamic Balance Scores in Breast Cancer

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey76 enrolled

Overview

To evaluate the effects of aromatase inhibitors on lower extremity ultrasonographic measurements, static and dynamic balance scores in breast cancer patients using aromatase inhibitors

Breast cancer is the most common cancer in women. 2/3 of breast cancer patients are estrogen and progesterone receptor positive. Tamoxifen or aromatase inhibitors are preferred in most of these patients depending on menopausal status. The increase in the life expectancy of breast cancer patients with medical treatments pushes us to find the cause of the drug side effects encountered during this extended life span and work on preventing/correcting them. It has been proven that aromatase inhibitors cause arthralgia in 40-50% of patients and a loss in bone mineral density, leading to a tendency towards osteoporosis. In this patient group, changes in the tendon and tendon sheath were also observed in ultrasonographic and magnetic resonance imaging and were stated to be the cause of the current symptoms. In the literature, breast cancer patients have been evaluated in detail in terms of balance, and it has been shown that static and dynamic body balance is worse in this group compared to the control group. Among the breast cancer population, the presence of arthralgia in the patient group using aromatase inhibitors causes an increased risk of falls. In addition, it is thought that lower extremity tendon changes may be a factor in balance and proprioception disorders. Based on this information, quantitative evaluation of static and dynamic balance in patients is important since there is an increase in the frequency of falls and a tendency to osteoporosis in patients using aromatase inhibitors in breast cancer. No similar study has been found in the literature.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Breast Cancer Aromatase Inhibitors Balanced

Eligibility

Sex: FEMALEMin age: 40 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Postmenopausal Woman * Between 40-70 ages * Stage 1-3 breast cancer * Chemotherapy treatment due to breast cancer (Last dosage at least 6 months ago) * Using an aromatase inhibitors for at least 1 year for group 1 * Never using an aromatase inhibitors at all for group 2 * Volunteers must sign and agree to participate in the study. Exclusion Criteria: * Stage 4 breast cancer * Having active chemotherapy * Older age patient (over 70 years old) * Using of steroid * Presence of diabetes mellitus that lasts longer than 3 years or insulin usage * Neuropathic complaints * Lack of vitamin B12 and thyroid dysfunction * Dn4 (dolour neuropathic 4 question) score of 4 and above * History of stroke * Presence of polyneuropathy diagnosis * Medication due to polyneuropathy diagnosis (gabapentin, pregabalin, duloxetine) * Loss of motor function in the lower extremity * Use of assistive devices for walking * Presence of vestibular disorder * Presence of cognitive impairment

Locations (1)

Ece Küçük

Istanbul, Turkey (Türkiye)

Outcomes

Primary Outcomes

Biodex Balance System

We will evaluate the patients with Limit of Stability test (LOS) protocols in the biodex balance system. For these tests, the rules specified in the Biodex guide will be applied and the results will be compared between two groups

Time frame: 5 months

Biodex Balance System

We will evaluate the patients with Fall Risk Test protocols in the biodex balance system. For these tests, the rules specified in the Biodex guide will be applied and the results will be compared between two groups

Time frame: 20 weeks

Biodex Balance System

We will evaluate the patients with Postural Stability Test protocols in the biodex balance system. Biodex guide will be applied and the results will be compared between two groups.

Time frame: 21 weeks

Secondary Outcomes

Time Up and Go test (TUG)

Time Up and Go test (TUG) will be used to determine dynamic balance.A performance longer than 12 seconds indicates an increased risk of falling.

Time frame: 6 months

Brief Pain Inventory

. Brief Pain Inventory determines the severity of pain, each question is scored out of 10 and the average is calculated. A score of 10 is indicative of the worst pain

Time frame: 20 weeks

Tinetti Balance and Gait Test

It will be used to determine the risk of falling. The maximum score is 35. High values indicate good balance.

Time frame: 21 weeks

Fall Efficiency Scale

Fall Efficiency Scale will be used to evaluate the fear of falling, and this test is a scale that evaluates patients' fears of falling. It consists of 10 questions scored out of 10. A score above 70 indicates a high fear of falling.

Data from ClinicalTrials.gov

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Time frame: 22 weeks

Womac pain index (The Western Ontario and McMaster Universities Arthritis Index)

Womac index: It consists of 24 different questions in 3 different categories. Each answer is scored between 0-4. 4 indicates the worst pain state.

Time frame: 20 weeks