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

NCT ID: NCT06184074

Last Updated: 2025-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

76 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-01

Study Completion Date

2024-08-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Breast Cancer Aromatase Inhibitors Balanced

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Breast Cancer Patients Using Aromatase Inhibitors Group

Breast cancer patients using aromatase inhibitors at least 1 year

No interventions assigned to this group

Breast Cancer Patients Group

Breast cancer patients who have not used aromatase inhibitors before

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ece Küçük

Role: PRINCIPAL_INVESTIGATOR

Sultan 2. Abdulhamid Han Training and Research Hospital

Locations

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Ece Küçük

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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23-17

Identifier Type: -

Identifier Source: org_study_id

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