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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06184074
• Other study ID #: 23-17
• Status: Recruiting
• Start date: February 1, 2024
• Est. completion date: July 1, 2024

Study information

• Verified date: December 2023
• Source: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
• Contact: Ece Küçük
• Phone: +905414997986
• Email: ecekk33[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. completion date: July 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Aromatase Inhibitors
• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
Turkey	Ece Küçük	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Time Up and Go test (TUG)	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
Secondary	Brief Pain Inventory	. 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
Secondary	Tinetti Balance and Gait Test	It will be used to determine the risk of falling. The maximum score is 35. High values indicate good balance.	21 weeks
Secondary	Fall Efficiency Scale	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
Secondary	Womac pain index (The Western Ontario and McMaster Universities Arthritis Index)	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
Secondary	The European Organization for Research and Treatment of Cancer breast cancer module (EORTC QLQ-BR23)	It is a breast-specific module consisting of 23 questions to evaluate discomfort caused by breast cancer. Body image will be evaluated.	18 weeks
Secondary	The European Organization for Research and Treatment of Cancer breast cancer module (EORTC QLQ-BR23)	It is a breast-specific module consisting of 23 questions to evaluate discomfort caused by breast cancer. Future perspective will be evaluated.	25 weeks
Secondary	The European Organization for Research and Treatment of Cancer breast cancer module (EORTC QLQ-BR23)	It is a breast-specific module consisting of 23 questions to evaluate discomfort caused by breast cancer. Breast symtoms will be evaluated.	24 weeks
Secondary	The European Organization for Research and Treatment of Cancer breast cancer module (EORTC QLQ-BR23)	It is a breast-specific module consisting of 23 questions to evaluate discomfort caused by breast cancer. Arm symtoms will be evaluated.	22 weeks
Secondary	The European Organization for Research and Treatment of Cancer Core module EORTC-QLQ-C30	It is a module consisting of 30 questions to evaluate discomfort caused cancer.	23 weeks
Secondary	The European Organization for Research and Treatment of Cancer breast cancer module (EORTC QLQ-BR23)	It is a scale designed to evaluate functional status in breast cancer patients.	6 months
Secondary	Patellar Tendon Ultrasound	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
Secondary	Patellar Tendon Ultrasound	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
Secondary	Quadriceps Tendon Ultrasound	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
Secondary	Quadriceps Tendon Ultrasound	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
Secondary	Achilles tendon ultrasound	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
Secondary	Achilles tendon ultrasound	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