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

NCT06184074 | Completed

• 1 other identifier: 23-17
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer; Aromatase Inhibitors; Balanced

Keywords

Aromatase Inhibitors; Breast Cancer

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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.

  21 weeks

Secondary Outcomes (17)

• Time Up and Go test (TUG)

  6 months

• Brief Pain Inventory

  20 weeks

• Tinetti Balance and Gait Test

  21 weeks

• Fall Efficiency Scale

  22 weeks

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

  20 weeks

Study Arms (2)

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

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey: lead

Study Sites (1)

Ece Küçük

Istanbul, 34457, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Ece Küçük

  Sultan 2. Abdulhamid Han Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: December 28, 2023
• Study Start: February 1, 2024
• Primary Completion: May 1, 2024
• Study Completion: August 1, 2024
• Last Updated: September 12, 2025

Record last verified: 2025-09

Locations

TU (1)