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RecruitingNCT07236658Updated Mar 31, 2026

Deep Learning for Musculoskeletal Complications in Breast Cancer

An observational study in Postmastectomy Lymphedema Syndrome, Breast Cancer Surgery Pain and Osteoporosis Secondary, sponsored by Ankara Etlik City Hospital. Recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-31.

Sponsored by Ankara Etlik City Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Jul 2026, 4 months ago, but the record still lists the study as recruiting.
  • Started Jul 2025; still recruiting 1 year 4 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
133
Ages
18 Years and older
Sex
Female
01

Study 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.

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.

02

Conditions studied

  • Postmastectomy Lymphedema Syndrome
  • Breast Cancer Surgery Pain
  • Osteoporosis Secondary
  • Shoulder Adhesive Capsulitis
  • Axillary Web Syndrome

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03

In context

Bursitis

383 studies on the registry are indexed under Bursitis; 111 are open to participants now.

This study's planned enrollment of 133 is above the median of 50 across 29 observational studies indexed under Bursitis.

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Lead sponsor

Ankara Etlik City Hospital is the lead sponsor of 176 studies on the registry; 77 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Female sex Age ≥18 years Scheduled for surgery due to unilateral breast cancer

Exclusion criteria

Exclusion Criteria:

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

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
133 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testphysical examination

    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.

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What researchers measure

Primary outcomes

  1. shoulder range of motion

    Shoulder range of motion will be measured in all directions using a goniometer before treatment and during follow-up visits

    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)

07

Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No — I do not consider sharing IPD ethically appropriate

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 31, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07236658
Responsible party
Başak Mansız-Kaplan (Assoc. Prof., Ankara Etlik City Hospital) — Principal investigator
First posted
Nov 19, 2025
Start date
Jul 1, 2025
Primary completion
Jul 1, 2026 (estimated)
Completion
Jan 1, 2027 (estimated)
Last update
Mar 31, 2026

Study contacts

Başak Mansız Kaplan
Contact
basakmansiz@hotmail.com
+905358582176

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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