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

September 5, 2025 updated by: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Effect of Aromatase Inhibitors on Lower Extremity Quantitative Ultrasonographic Measurements and Static and Dynamic Balance Scores in Breast Cancer Patients Using Aromatase Inhibitors

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

Study Overview

Status

Completed

Conditions

Detailed Description

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 (Actual)

76

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Postmenopausal woman with breast cancer, between 40-70 years old

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Breast Cancer Patients Using Aromatase Inhibitors Group
Breast cancer patients using aromatase inhibitors at least 1 year
Breast Cancer Patients Group
Breast cancer patients who have not used aromatase inhibitors before

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biodex Balance System
Time Frame: 5 months
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
5 months
Biodex Balance System
Time Frame: 20 weeks
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
20 weeks
Biodex Balance System
Time Frame: 21 weeks
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.
21 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time Up and Go test (TUG)
Time Frame: 6 months
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.
6 months
Brief Pain Inventory
Time Frame: 20 weeks
. 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
20 weeks
Tinetti Balance and Gait Test
Time Frame: 21 weeks
It will be used to determine the risk of falling. The maximum score is 35. High values indicate good balance.
21 weeks
Fall Efficiency Scale
Time Frame: 22 weeks
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.
22 weeks
Womac pain index (The Western Ontario and McMaster Universities Arthritis Index)
Time Frame: 20 weeks
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.
20 weeks
The European Organization for Research and Treatment of Cancer breast cancer module (EORTC QLQ-BR23)
Time Frame: 18 weeks
It is a breast-specific module consisting of 23 questions to evaluate discomfort caused by breast cancer. Body image will be evaluated.
18 weeks
The European Organization for Research and Treatment of Cancer breast cancer module (EORTC QLQ-BR23)
Time Frame: 25 weeks
It is a breast-specific module consisting of 23 questions to evaluate discomfort caused by breast cancer. Future perspective will be evaluated.
25 weeks
The European Organization for Research and Treatment of Cancer breast cancer module (EORTC QLQ-BR23)
Time Frame: 24 weeks
It is a breast-specific module consisting of 23 questions to evaluate discomfort caused by breast cancer. Breast symtoms will be evaluated.
24 weeks
The European Organization for Research and Treatment of Cancer breast cancer module (EORTC QLQ-BR23)
Time Frame: 22 weeks
It is a breast-specific module consisting of 23 questions to evaluate discomfort caused by breast cancer. Arm symtoms will be evaluated.
22 weeks
The European Organization for Research and Treatment of Cancer Core module EORTC-QLQ-C30
Time Frame: 23 weeks
It is a module consisting of 30 questions to evaluate discomfort caused cancer.
23 weeks
The European Organization for Research and Treatment of Cancer breast cancer module (EORTC QLQ-BR23)
Time Frame: 6 months
It is a scale designed to evaluate functional status in breast cancer patients.
6 months
Patellar Tendon Ultrasound
Time Frame: 23 weeks
The short axis of the ultrasound probe will be placed in the vertical plane, 6 mm below the lower pole of the patella and the patellar tendon will be imaged with ultrasound. Echogenicity will be calculated by uploading the image to the image j system. Lower values of echogenicity will indicate worse tendon quality
23 weeks
Patellar Tendon Ultrasound
Time Frame: 22 weeks
The patellar tendon will be visualized by placing its long axis in a vertical plane 6 mm below the lower pole of the patella. Tendon thickness will be measured from this location(mm)
22 weeks
Quadriceps Tendon Ultrasound
Time Frame: 20 weeks
The short long of the ultrasound probe will be placed in the vertical plane, 10 mm above the upper pole of the patella.Tendon thickness will be measured from this location(mm)
20 weeks
Quadriceps Tendon Ultrasound
Time Frame: 22 weeks
The short axis of the ultrasound probe will be placed in the vertical plane, 10 mm above the upper pole of the patella.Echogenicity will be calculated by uploading the image to the image j system.Lower values of echogenicity will indicate worse tendon quality
22 weeks
Achilles tendon ultrasound
Time Frame: 21 weeks
The short axis of the ultrasound probe will be placed in a vertical plane 2 cm above the distal calcaneus and the Achilles tendon will be visualized with ultrasound.Echogenicity will be calculated by uploading the image to the image j system.Lower values of echogenicity will indicate worse tendon quality.
21 weeks
Achilles tendon ultrasound
Time Frame: 20 weeks
The short axis of the ultrasound probe will be placed in a vertical plane 2 cm above the distal calcaneus and the Achilles tendon will be visualized with ultrasound.Tendon thickness will be measured from this location(mm)
20 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Investigators

  • Principal Investigator: Ece Küçük, Sultan 2. Abdulhamid Han Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2024

Primary Completion (Actual)

May 1, 2024

Study Completion (Actual)

August 1, 2024

Study Registration Dates

First Submitted

November 21, 2023

First Submitted That Met QC Criteria

December 14, 2023

First Posted (Actual)

December 28, 2023

Study Record Updates

Last Update Posted (Estimated)

September 12, 2025

Last Update Submitted That Met QC Criteria

September 5, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-17

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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