Effects of aromatase inhibitors on balance in breast cancer patients
Effect of Aromatase Inhibitors on Lower Extremity Quantitative Ultrasonographic Measurements and Static and Dynamic Balance Scores in Breast Cancer Patients Using Aromatase Inhibitors
This study is testing how aromatase inhibitors affect balance and leg health in postmenopausal women with breast cancer who have been using these medications for at least a year.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 76 (estimated) |
| Ages | 40 Years to 70 Years |
| Sex | Female |
| Sponsor | Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey Academic / other |
| Drugs / interventions | Chemotherapy |
| Locations | 1 site (Istanbul) |
| Trial ID | NCT06184074 on ClinicalTrials.gov |
What this trial studies
This study evaluates how aromatase inhibitors affect lower extremity ultrasonographic measurements and balance scores in postmenopausal women with breast cancer. It focuses on patients who have been using these medications for at least one year and compares them to those who have never used them. The study aims to understand the relationship between these medications, balance issues, and the risk of falls, particularly in patients experiencing arthralgia and changes in tendon structure. By assessing both static and dynamic balance, the research seeks to identify potential interventions to improve patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are postmenopausal women aged 40-70 with stage 1-3 breast cancer who have been on aromatase inhibitors for at least one year.
Not a fit: Patients with stage 4 breast cancer, active chemotherapy, or significant comorbidities such as diabetes or neuropathy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for balance and fall risk in breast cancer patients using aromatase inhibitors.
How similar studies have performed: While there is existing literature on balance issues in breast cancer patients, this specific evaluation of aromatase inhibitors' effects on balance is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Istanbul
- Ece Küçük — Istanbul, Turkey (Recruiting)
Study contacts
- Principal investigator: Ece Küçük — Sultan 2. Abdulhamid Han Training and Research Hospital
- Study coordinator: Ece Küçük
- Email: ecekk33@gmail.com
- Phone: +905414997986
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.