Breast CancerNCT06184074
Effect of Aromatase Inhibitors on Ultrasonographic Measurements and Static and Dynamic Balance Scores in Breast Cancer
An observational study of Breast Cancer and Aromatase Inhibitors, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
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 Read more about this study
- Who is it for?
- Ages 40 to 70 years, women only
- Conditions the study is for
- Breast Cancer, Aromatase Inhibitors, Balanced
- How many people
- 76 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2024to 1 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Postmenopausal woman with breast cancer, between 40-70 years old
Who may be able to join
- 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.
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
To evaluate the effects of aromatase inhibitors on lower extremity ultrasonographic measurements, static and dynamic balance scores in breast cancer patients using aromatase inhibitors
Read the 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.
- Conditions
- Breast Cancer, Aromatase Inhibitors, Balanced
- Keywords
- Aromatase Inhibitors, Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 21 weeks
Secondary outcomes (17)
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.
Measured: 6 months
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
Measured: 20 weeks
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.
Measured: 21 weeks
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.
Measured: 22 weeks
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.
Measured: 20 weeks
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.
Measured: 18 weeks
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.
Measured: 25 weeks
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.
Measured: 24 weeks
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.
Measured: 22 weeks
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.
Measured: 23 weeks
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.
Measured: 6 months
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
Measured: 23 weeks
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)
Measured: 22 weeks
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)
Measured: 20 weeks
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
Measured: 22 weeks
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.
Measured: 21 weeks
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)
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2023
- Study start1 Feb 2024
- Primary completion1 May 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ece Küçük, Principal investigator, Sultan 2. Abdulhamid Han Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06184074
- Sponsor's protocol ID
- 23-17
- Status last verified
- Sep 2025
- First submitted
- 21 Nov 2023
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06184074
- Acronym / sponsor ID
- 23-17
- Conditions
- Breast Cancer, Aromatase Inhibitors, Balanced
- Keywords
- Aromatase Inhibitors, Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 28 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Postmenopausal woman with breast cancer, between 40-70 years old
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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.
17 secondary outcomes
Time Up and Go test (TUG)
Time frame: 6 months
Brief Pain Inventory
Time frame: 20 weeks
Tinetti Balance and Gait Test
Time frame: 21 weeks
Fall Efficiency Scale
Time frame: 22 weeks
Womac pain index (The Western Ontario and McMaster Universities Arthritis Index)
Time frame: 20 weeks
The European Organization for Research and Treatment of Cancer breast cancer module (EORTC QLQ-BR23)
Time frame: 18 weeks
The European Organization for Research and Treatment of Cancer breast cancer module (EORTC QLQ-BR23)
Time frame: 25 weeks
The European Organization for Research and Treatment of Cancer breast cancer module (EORTC QLQ-BR23)
Time frame: 24 weeks
The European Organization for Research and Treatment of Cancer breast cancer module (EORTC QLQ-BR23)
Time frame: 22 weeks
The European Organization for Research and Treatment of Cancer Core module EORTC-QLQ-C30
Time frame: 23 weeks
The European Organization for Research and Treatment of Cancer breast cancer module (EORTC QLQ-BR23)
Time frame: 6 months
Patellar Tendon Ultrasound
Time frame: 23 weeks
Patellar Tendon Ultrasound
Time frame: 22 weeks
Quadriceps Tendon Ultrasound
Time frame: 20 weeks
Quadriceps Tendon Ultrasound
Time frame: 22 weeks
Achilles tendon ultrasound
Time frame: 21 weeks
Achilles tendon ultrasound
Time frame: 20 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ece Küçük principal investigator
Sultan 2. Abdulhamid Han Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Aromatase Inhibitors, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biodex Balance System (time frame: 5 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025; AzTrials last refreshed its copy on 8 Nov 2026.