Effect of BOSU Exercises Added to Complete Decongestive Treatment on Balance in Breast Cancer-ass… (NCT06182046) | Clinical Trial Compass
UnknownNot Applicable
Effect of BOSU Exercises Added to Complete Decongestive Treatment on Balance in Breast Cancer-associated Lymphedema.
40 participantsStarted 2024-01-01
Plain-language summary
The aim of the study is to investigate the effect of balance exercises performed with the BOSU ball added to complete decongestive treatment on static and dynamic balance in patients with breast cancer-related lymphedema.
Who can participate
Age range
18 Years – 65 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Female gender
* Patients aged 18-65 years
* Having a history of unilateral mastectomy and lymph node dissection at least one year ago due to breast cancer diagnosis.
* Having unilateral breast cancer-related upper extremity lymphedema (\>20% volume difference between the two upper extremities) according to the diagnostic criteria of the - International Society of Lymphology (Committee 2020) for at least six months.
* Not having received lymphedema treatment or exercise therapy for the last six months
* Completing breast cancer primary treatment at least 6 months ago (except hormone therapy/aromatase inhibitors)
Exclusion Criteria:
* Bilateral breast cancer
* Bilateral axillary lymph node dissection
* Metastatic breast cancer
* Receiving ongoing radiotherapy or chemotherapy
* Primary or bilateral lymphedema
* Having active cancer
* Presence of stage 3 lymphedema
* Uncontrolled serious systemic disease (cardiopulmonary diseases, arterial or venous diseases, renal dysfunction, uncontrolled hypertension or hypotension).
* Active or previous infection in the last 3 months (cellulitis, lymphangitis)
* Presence of open wounds
* Having any problems that may affect balance (vestibular, visual, neurological or orthopedic diseases)
* Using medications that may affect body fluid and electrolyte balance (diuretics, etc.).
* Individuals with serious mental and sensory problems
* History of spine surgery in the last 6 months
* Being pregnant
* Body mass index \>40 k…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Static balance measurements
Timeframe: 1 day before rehabilitation
2
Static balance measurements
Timeframe: 3 weeks after the start of rehabilitation
3
Dynamic balance measurements
Timeframe: 1 day before rehabilitation
4
Dynamic balance measurements
Timeframe: 3 weeks after the start of rehabilitation