Postmastectomy Lymphedema SyndromeNCT07236658
Deep Learning for Musculoskeletal Complications in Breast Cancer
An observational study of Postmastectomy Lymphedema Syndrome and Breast Cancer Surgery Pain, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Survival after breast cancer has increased due to early diagnosis and advances in treatment methods. Musculoskeletal problems related to cancer and its treatment constitute a significant part of the daily practice of physiatrists and rehabilitation specialists involved in oncological rehabilitation. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postmastectomy Lymphedema Syndrome, Breast Cancer Surgery Pain, Osteoporosis Secondary
- What is being tested?
- physical examination
- How many people
- 133 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2025to 1 Jan 2027
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The study will include adult women (over 18 years of age) who are scheduled to undergo surgery for unilateral breast cancer. Patients with a history of bilateral breast cancer, male breast cancer, inability to comply with follow-up visits, or those who are children, pregnant, postpartum, breastfeeding, in intensive care, or with impaired consciousness, as well as legally incapacitated individuals, will be excluded
Who may be able to join
- Female sex Age ≥18 years Scheduled for surgery due to unilateral breast cancer
Who cannot join
- Inability to comply with follow-up visits Bilateral breast cancer Male breast cancer Children (<18 years) Pregnant women Postpartum women Breastfeeding women Individuals in intensive care Impaired consciousness Legally incapacitated individuals
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Etlik City Hospital
Ankara
About this study
Official title: AI-Powered Deep Learning Models for Prospective Prediction of Musculoskeletal Complications After Breast Cancer Surgery: Focus on Lymphedema, Axillary Web Syndrome, Neuropathy, and Pain
Survival after breast cancer has increased due to early diagnosis and advances in treatment methods. Musculoskeletal problems related to cancer and its treatment constitute a significant part of the daily practice of physiatrists and rehabilitation specialists involved in oncological rehabilitation.
Lymphedema can occur at any stage of a patient's life following breast cancer. Patients with breast cancer-related lymphedema require lifelong treatment, and as the stage of lymphedema progresses, response to therapy decreases. Advanced stages of lymphedema negatively affect functional status, and patients experience difficulties in performing activities of daily living.
Read more
Axillary web syndrome (AWS) is characterized by a taut cord extending from the axilla to the volar surface of the wrist, typically appearing within the first 8 weeks postoperatively. AWS can complicate the administration of radiotherapy. Shoulder dysfunction may occur independently or in association with AWS. In particular, scapular dyskinesis developing after mastectomy can lead to secondary shoulder conditions such as rotator cuff syndrome or adhesive capsulitis, which are commonly observed in these patients.
Peripheral neuropathy is frequently seen in patients receiving chemotherapy, adversely affecting daily life and sometimes preventing continuation of treatment. Other complications related to chemotherapy and radiotherapy include cardiotoxicity, pulmonary toxicity, fatigue, osteoporosis, and cognitive impairment.
There are also specific painful syndromes that may occur after breast cancer, including post-mastectomy pain syndrome, phantom breast pain, and musculoskeletal symptoms associated with aromatase inhibitors. All these conditions can significantly impair daily functioning and even hinder continuation of cancer treatment. Therefore, predicting these complications and implementing or developing preventive interventions is crucial.
If it is possible to predict the early development of lymphedema, axillary web syndrome, peripheral neuropathy, and painful syndromes after breast cancer, early intervention may prevent progression. This study is designed to develop and validate a predictive model using deep learning methods to determine the risk of these complications in patients undergoing breast cancer surgery. Among deep learning architectures, ResNet50, AlexNet, GoogleNet, and UNet, which have been widely used in recent studies, are planned to be implemented.
Additionally, based on the results of this study, a risk calculation program will be developed, allowing clinicians to input baseline patient data and calculate the individual patient's risk for each complication prior to treatment. No specific risk is expected in the study.
- Conditions
- Postmastectomy Lymphedema Syndrome, Breast Cancer Surgery Pain, Osteoporosis Secondary, Shoulder Adhesive Capsulitis, Axillary Web Syndrome
- Being tested
- physical examination
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical examinationDiagnostic test
Demographic data and upper-extremity circumferential measurements, shoulder range of motion, upper-extremity dermatome examination, pathological diagnosis and stage, treatments received, comorbidities, and routine laboratory tests including ESR, CRP, complete blood count, ALT, AST, protein, albumin, BUN, creatinine, and GFR will be recorded. The VAS (Visual Analog Scale), Central Sensitization Inventory, Hospital Anxiety and Depression Scale, and Quick-DASH disability questionnaire will be completed.
During monthly follow-ups, if the patient receives radiotherapy (RT) or chemotherapy (CT), these data will be documented in terms of number and dose. In addition to the physical examination performed at each follow-up visit (baseline, month 1, month 3, and month 6), the Hospital Anxiety and Depression Scale and the Quick-DASH disability questionnaire.
At the final 6-month follow-up, all assessments will be repeated, and data will be analyzed after the last patient has completed follow-up.
What is being measured
The primary outcome is the main question the study is designed to answer.
shoulder range of motion
Shoulder range of motion will be measured in all directions using a goniometer before treatment and during follow-up visits
Measured: shoulder range of motion will be measured in all directions using a goniometer before treatment and during follow-up visits. (0, month 1, month 3, month 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start1 Jul 2025
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmastectomy Lymphedema SyndromeStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 133 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Başak Mansız-Kaplan, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07236658
- Sponsor's protocol ID
- AEŞH-EK-2025-145
- Status last verified
- Nov 2025
- First submitted
- 15 Nov 2025
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I do not consider sharing IPD ethically appropriate
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AI-Powered Deep Learning Models for Prospective Prediction of Musculoskeletal Complications After Breast Cancer Surgery: Focus on Lymphedema, Axillary Web Syndrome, Neuropathy, and Pain
- ClinicalTrials.gov ID
- NCT07236658
- Acronym / sponsor ID
- AEŞH-EK-2025-145
- Conditions
- Postmastectomy Lymphedema Syndrome, Breast Cancer Surgery Pain, Osteoporosis Secondary, Shoulder Adhesive Capsulitis, Axillary Web Syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 133 participants (estimated)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 19 Nov 2025 (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.
Survival after breast cancer has increased due to early diagnosis and advances in treatment methods. Musculoskeletal problems related to cancer and its treatment constitute a significant part of the daily practice of physiatrists and rehabilitation specialists involved in oncological rehabilitation.
Lymphedema can occur at any stage of a patient's life following breast cancer. Patients with breast cancer-related lymphedema require lifelong treatment, and as the stage of lymphedema progresses, response to therapy decreases. Advanced stages of lymphedema negatively affect functional status, and patients experience difficulties in performing activities of daily living.
Axillary web syndrome (AWS) is characterized by a taut cord extending from the axilla to the volar surface of the wrist, typically appearing within the first 8 weeks postoperatively. AWS can complicate the administration of radiotherapy. Shoulder dysfunction may occur independently or in association with AWS. In particular, scapular dyskinesis developing after mastectomy can lead to secondary shoulder conditions such as rotator cuff syndrome or adhesive capsulitis, which are commonly observed in these patients.
Peripheral neuropathy is frequently seen in patients receiving chemotherapy, adversely affecting daily life and sometimes preventing continuation of treatment. Other complications related to chemotherapy and radiotherapy include cardiotoxicity, pulmonary toxicity, fatigue, osteoporosis, and cognitive impairment.
There are also specific painful syndromes that may occur after breast cancer, including post-mastectomy pain syndrome, phantom breast pain, and musculoskeletal symptoms associated with aromatase inhibitors. All these conditions can significantly impair daily functioning and even hinder continuation of cancer treatment. Therefore, predicting these complications and implementing or developing preventive interventions is crucial.
If it is possible to predict the early development of lymphedema, axillary web syndrome, peripheral neuropathy, and painful syndromes after breast cancer, early intervention may prevent progression. This study is designed to develop and validate a predictive model using deep learning methods to determine the risk of these complications in patients undergoing breast cancer surgery. Among deep learning architectures, ResNet50, AlexNet, GoogleNet, and UNet, which have been widely used in recent studies, are planned to be implemented.
Additionally, based on the results of this study, a risk calculation program will be developed, allowing clinicians to input baseline patient data and calculate the individual patient's risk for each complication prior to treatment. No specific risk is expected in the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include adult women (over 18 years of age) who are scheduled to undergo surgery for unilateral breast cancer. Patients with a history of bilateral breast cancer, male breast cancer, inability to comply with follow-up visits, or those who are children, pregnant, postpartum, breastfeeding, in intensive care, or with impaired consciousness, as well as legally incapacitated individuals, will be excluded
Key inclusion criteria (1 listed)
- Female sex Age ≥18 years Scheduled for surgery due to unilateral breast cancer
Key exclusion criteria (1 listed)
- Inability to comply with follow-up visits Bilateral breast cancer Male breast cancer Children (<18 years) Pregnant women Postpartum women Breastfeeding women Individuals in intensive care Impaired consciousness Legally incapacitated individuals
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| physical examinationDemographic data and upper-extremity circumferential measurements, shoulder range of motion, upper-extremity dermatome examination, pathological diagnosis and stage, treatments received, comorbidities, and routine laboratory tests including ESR, CRP, complete blood count, ALT, AST, protein, albumin, BUN, creatinine, and GFR will be recorded. The VAS (Visual Analog Scale), Central Sensitization Inventory, Hospital Anxiety and Depression Scale, and Quick-DASH disability questionnaire will be completed. During monthly follow-ups, if the patient receives radiotherapy (RT) or chemotherapy (CT), these data will be documented in terms of number and dose. In addition to the physical examination performed at each follow-up visit (baseline, month 1, month 3, and month 6), the Hospital Anxiety and Depression Scale and the Quick-DASH disability questionnaire. At the final 6-month follow-up, all assessments will be repeated, and data will be analyzed after the last patient has completed follow-up. | Diagnostic test | – |
Primary outcome
shoulder range of motion
Time frame: shoulder range of motion will be measured in all directions using a goniometer before treatment and during follow-up visits. (0, month 1, month 3, month 6)
Shoulder range of motion will be measured in all directions using a goniometer before treatment and during follow-up visits
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 31 Mar 2026.
- Individual participant dataSharing planned: No. I do not consider sharing IPD ethically appropriate
Related trials for Postmastectomy Lymphedema Syndrome
Active, not recruiting
Lymphaticovenous Anastomosis as Treatment for Lymphedema
Breast Cancer Lymphedema, Secondary Lymphedema
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.
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 Postmastectomy Lymphedema Syndrome and Breast Cancer Surgery Pain, run by Ankara Etlik 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 31 Mar 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?
Contact Başak Mansız Kaplan (+905358582176, basakmansiz@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
shoulder range of motion (time frame: shoulder range of motion will be measured in all directions using a goniometer before treatment and during follow-up visits. (0, month 1, month 3, month 6)). 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 31 Mar 2026.