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NCT Number: NCT06184074

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

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

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Key information

Conditions

Breast Cancer Aromatase Inhibitors Balanced Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

40 year–70 year

Sex eligibility

Female

Study type

Observational

Primary location

Ece Küçük

Istanbul, 34457, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

  3. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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

  13. 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)

  14. 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)

  15. 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

  16. 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.

  17. 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)

Sponsors and collaborators

Lead sponsor

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 28, 2023
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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