Breast Cancer LymphedemaBCRLNCT07420725
The Relationship Between Gait Parameters and Balance Disorder and Fall Risk in Breast Cancer-Related Lymphedema(BCRL)
An observational study of Breast Cancer Lymphedema, run by Kayseri City Hospital at 1 site in Turkey (Türkiye).
Trial summary
In this study, researchers aimed to evaluate walking function, balance, and fall risk in patients with breast cancer-related lymphedema. The researchers' hypothesis is that balance and walking functions are affected due to a shift in the center of gravity in patients with breast cancer-related lymphedema, and that the… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Lymphedema
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Feb 2026to 10 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Female patients aged 18-65 years who presented to the Lymphedema outpatient clinic of the Physical Medicine and Rehabilitation Department at Kayseri City Hospital with upper extremity swelling following breast cancer surgery and/or radiation therapy and were diagnosed with BRCL (Group 1: LG, lymphedema group) will be included in the study. The control group (Group 2: KG) will consist of age- and gender-matched volunteer participants who presented to the Physical Medicine and Rehabilitation outpatient clinics with non-specific pain complaints and who did not have any postural, neurological, or orthopedic disorders.
Who may be able to join
- Women aged 18-65 with breast cancer-related ISL Stage 2-3 unilateral upper extremity breast cancer-related lymphedema
- Healthy female control group matched for age and gender with the patient group aged 18-65
- Participants who agreed to participate in the study and provided written consent
Who cannot join
- Presence of underlying diseases that may affect extremity volume other than lymphedema
- Presence of phleboedema, lipedema, cellulitis, lymphocele
- Presence of acute infection
- Presence of acute/chronic lung disease (history of acute pulmonary embolism, acute bronchial asthma attack, chronic interstitial lung disease)
- Chronic liver failure
- Renal dysfunction
Show all 10Show fewer
- Uncontrolled hypertension and diabetes mellitus
- Presence of orthopedic diseases that may impede walking (joint limitation, ankylosis, amputation)
- Patients who refused to participate in the study
- Patients who lacked cooperation and compliance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relationship Between Gait Parameters and Balance Disorder and Fall Risk in Breast Cancer-Related Lymphedema (BCRL)
In this study, researchers aimed to evaluate walking function, balance, and fall risk in patients with breast cancer-related lymphedema. The researchers' hypothesis is that balance and walking functions are affected due to a shift in the center of gravity in patients with breast cancer-related lymphedema, and that the risk of falls is increased in the patient population compared to the control group.
Read the detailed description
In this study, researchers aimed to evaluate walking function, balance, and fall risk in patients with breast cancer-related lymphedema. The researchers' hypothesis is that balance and walking functions are affected due to a shift in the center of gravity in patients with breast cancer-related lymphedema, and that the risk of falls is increased in the patient population compared to the control group.
- Conditions
- Breast Cancer Lymphedema
- Medical subject headings
- Breast Cancer Lymphedema
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 |
|---|---|---|
| Patient group | Female patients aged 18-65 years who are evaluated for upper extremity swelling after breast cancer surgery and/or radiation therapy and diagnosed with BRCL | |
| Control group | Patient group aged 18-65 and age and gender-matched healthy female control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait analysis
The individual's walking performance will be measured using standard methods employed in clinical assessments and gait analysis studies. Measurements will be conducted in our clinic using the Zebris FDM 2 gait analysis system, and evaluations carried out with different measurement units will be reported as separate outcome criteria.
Measured: 01 January 2026- 10 July 2026
The Fullerton Advanced Balance Scale (FAB-Scale)
The FAB Scale is a performance-based test that assesses functional balance (static and dynamic). Functional balance includes static and dynamic components such as the body's overall balance ability, muscle coordination, proprioception, range of motion, muscle strength, and flexibility.
Measured: 01 January 2026- 10 July 2026
Modified Fall Effectiveness Scale (MFES)
The MFES is a self-report scale used to assess individuals' levels of fear of falling while performing various daily life activities. An adaptation of the Tinetti Fall Activity Scale (FES), the MFES aims to improve cultural adaptability by more comprehensively evaluating social and environmental factors.
Measured: 01 January 2026- 10 July 2026
Quick-DASH (Q-DASH)
The Q-DASH consists of 11 items derived from the DASH questionnaire to measure physical function and symptoms of the upper extremity. This index assesses the difficulties patients have experienced in daily living activities over the past week using a 5-point Likert scale. At least 10 out of 11 items must be answered to calculate the Q-DASH score. All items in the questionnaire are scored between 1 and 5. A score of 1 indicates no difficulty during the activity, while a score of 5 indicates complete inability to perform the activity. The Q-DASH has been found to be valid and reliable for assessing upper extremity activity limitations in breast cancer patients.
Measured: 01 ocak 2026- 10 temmuz 2026
LYMQO-Arm Index
The LYMQOL Arm Index is a tool that measures the impact of lymphedema on arm function and assesses its effects on quality of life. It measures the effects on arm function, psychological health, social interactions, and physical symptoms. The index allows monitoring of arm swelling, pain, limitations in movement, and the impact of these effects on psychological and social life.
Measured: 01 January 2026- 10 July 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start5 Feb 2026
- Primary completion10 Jul 2026 (estimated)
- Study completion10 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer LymphedemaStudies 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
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kayseri City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Fatma Gül Ülkü Demir, Kayseri City Hospital
- Investigators
- Fatma G Ülkü Demir, baş araştırmacı, Principal investigator, Kayseri City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07420725
- Sponsor's protocol ID
- BCRL
- Acronym
- BCRL
- Status last verified
- Apr 2026
- First submitted
- 4 Feb 2026
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Gait Parameters and Balance Disorder and Fall Risk in Breast Cancer-Related Lymphedema (BCRL)
- ClinicalTrials.gov ID
- NCT07420725
- Acronym / sponsor ID
- BCRL / BCRL
- Conditions
- Breast Cancer Lymphedema
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Kayseri City HospitalOther government
- Study start
- 5 Feb 2026 (actual)
- Primary completion
- 10 Jul 2026 (estimated)
- Study completion
- 10 Jul 2026 (estimated)
- First posted
- 19 Feb 2026 (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.
In this study, researchers aimed to evaluate walking function, balance, and fall risk in patients with breast cancer-related lymphedema. The researchers' hypothesis is that balance and walking functions are affected due to a shift in the center of gravity in patients with breast cancer-related lymphedema, and that the risk of falls is increased in the patient population compared to the control group.
Detailed description
In this study, researchers aimed to evaluate walking function, balance, and fall risk in patients with breast cancer-related lymphedema. The researchers' hypothesis is that balance and walking functions are affected due to a shift in the center of gravity in patients with breast cancer-related lymphedema, and that the risk of falls is increased in the patient population compared to the control group.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient group | – | –Female patients aged 18-65 years who are evaluated for upper extremity swelling after breast cancer surgery and/or radiation therapy and diagnosed with BRCL |
| Control group | – | –Patient group aged 18-65 and age and gender-matched healthy female control group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Female patients aged 18-65 years who presented to the Lymphedema outpatient clinic of the Physical Medicine and Rehabilitation Department at Kayseri City Hospital with upper extremity swelling following breast cancer surgery and/or radiation therapy and were diagnosed with BRCL (Group 1: LG, lymphedema group) will be included in the study. The control group (Group 2: KG) will consist of age- and gender-matched volunteer participants who presented to the Physical Medicine and Rehabilitation outpatient clinics with non-specific pain complaints and who did not have any postural, neurological, or orthopedic disorders.
Key inclusion criteria (3 listed)
- Women aged 18-65 with breast cancer-related ISL Stage 2-3 unilateral upper extremity breast cancer-related lymphedema
- Healthy female control group matched for age and gender with the patient group aged 18-65
- Participants who agreed to participate in the study and provided written consent
Key exclusion criteria (10 listed)
- Presence of underlying diseases that may affect extremity volume other than lymphedema
- Presence of phleboedema, lipedema, cellulitis, lymphocele
- Presence of acute infection
- Presence of acute/chronic lung disease (history of acute pulmonary embolism, acute bronchial asthma attack, chronic interstitial lung disease)
- Chronic liver failure
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
Gait analysis
Time frame: 01 January 2026- 10 July 2026
The individual's walking performance will be measured using standard methods employed in clinical assessments and gait analysis studies. Measurements will be conducted in our clinic using the Zebris FDM 2 gait analysis system, and evaluations carried out with different measurement units will be reported as separate outcome criteria.
The Fullerton Advanced Balance Scale (FAB-Scale)
Time frame: 01 January 2026- 10 July 2026
The FAB Scale is a performance-based test that assesses functional balance (static and dynamic). Functional balance includes static and dynamic components such as the body's overall balance ability, muscle coordination, proprioception, range of motion, muscle strength, and flexibility.
Modified Fall Effectiveness Scale (MFES)
Time frame: 01 January 2026- 10 July 2026
The MFES is a self-report scale used to assess individuals' levels of fear of falling while performing various daily life activities. An adaptation of the Tinetti Fall Activity Scale (FES), the MFES aims to improve cultural adaptability by more comprehensively evaluating social and environmental factors.
Quick-DASH (Q-DASH)
Time frame: 01 ocak 2026- 10 temmuz 2026
The Q-DASH consists of 11 items derived from the DASH questionnaire to measure physical function and symptoms of the upper extremity. This index assesses the difficulties patients have experienced in daily living activities over the past week using a 5-point Likert scale. At least 10 out of 11 items must be answered to calculate the Q-DASH score. All items in the questionnaire are scored between 1 and 5. A score of 1 indicates no difficulty during the activity, while a score of 5 indicates complete inability to perform the activity. The Q-DASH has been found to be valid and reliable for assessing upper extremity activity limitations in breast cancer patients.
LYMQO-Arm Index
Time frame: 01 January 2026- 10 July 2026
The LYMQOL Arm Index is a tool that measures the impact of lymphedema on arm function and assesses its effects on quality of life. It measures the effects on arm function, psychological health, social interactions, and physical symptoms. The index allows monitoring of arm swelling, pain, limitations in movement, and the impact of these effects on psychological and social life.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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.
Fatma G Ülkü Demir, baş araştırmacı principal investigator
Kayseri City 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 Lymphedema, run by Kayseri City Hospital 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 3 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 9 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Gait analysis (time frame: 01 January 2026- 10 July 2026). The study lists 5 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 9 Apr 2026.