Clinical trial NCT06184074: Effect of Aromatase Inhibitors on Ultrasonographic Measurements and Static and Dynamic Balance Scores in Breast Cancer
Official title: Effect of Aromatase Inhibitors on Lower Extremity Quantitative Ultrasonographic Measurements and Static and Dynamic Balance Scores in Breast Cancer Patients Using Aromatase Inhibitors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Aromatase Inhibitors
Balanced
Keywords: Aromatase Inhibitors
Breast Cancer
Lead sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Sponsor class: OTHER
First posted: 2023-12-28
Enrollment: 76
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Postmenopausal woman with breast cancer, between 40-70 years old

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Biodex Balance System
timeFrame: 5 months
measure: Biodex Balance System
timeFrame: 20 weeks
measure: Biodex Balance System
timeFrame: 21 weeks
Secondary outcomes:
measure: Time Up and Go test (TUG)
timeFrame: 6 months
measure: Brief Pain Inventory
timeFrame: 20 weeks
measure: Tinetti Balance and Gait Test
timeFrame: 21 weeks
measure: Fall Efficiency Scale
timeFrame: 22 weeks
measure: Womac pain index (The Western Ontario and McMaster Universities Arthritis Index)
timeFrame: 20 weeks
measure: The European Organization for Research and Treatment of Cancer breast cancer module (EORTC QLQ-BR23)
timeFrame: 18 weeks
measure: The European Organization for Research and Treatment of Cancer breast cancer module (EORTC QLQ-BR23)
timeFrame: 25 weeks
measure: The European Organization for Research and Treatment of Cancer breast cancer module (EORTC QLQ-BR23)
timeFrame: 24 weeks
measure: The European Organization for Research and Treatment of Cancer breast cancer module (EORTC QLQ-BR23)
timeFrame: 22 weeks
measure: The European Organization for Research and Treatment of Cancer Core module EORTC-QLQ-C30
timeFrame: 23 weeks
measure: The European Organization for Research and Treatment of Cancer breast cancer module (EORTC QLQ-BR23)
timeFrame: 6 months
measure: Patellar Tendon Ultrasound
timeFrame: 23 weeks
measure: Patellar Tendon Ultrasound
timeFrame: 22 weeks
measure: Quadriceps Tendon Ultrasound
timeFrame: 20 weeks
measure: Quadriceps Tendon Ultrasound
timeFrame: 22 weeks
measure: Achilles tendon ultrasound
timeFrame: 21 weeks
measure: Achilles tendon ultrasound
timeFrame: 20 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Ece Küçük
Study officials:
affiliation: Sultan 2. Abdulhamid Han Training and Research Hospital
name: Ece Küçük
role: PRINCIPAL_INVESTIGATOR
References: