RecruitingNot ApplicableNCT04665882

Nomogram to Predict Breast Cancer Related Lymphedema

Intraoperative Nomogram to Predict Breast Cancer- Related Lymphedema Based in Artificial Intelligence Image Recognition: a Randomized Controlled Trial


Sponsor

Wuhan University

Enrollment

600 participants

Start Date

Dec 11, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

It has been hypothesized that damaged arm lymphatic drainage is associated with the arm lymphedema after axillary lymph node dissection (ALND). However, the majority of breast cancer patients with complete ALND has not suffered from arm lymphedema, which appears to be due to the residual arm lymph nodes that has not been removed in the axillary dissection. With the compensation of the residual arm lymph flow above the level of axillary vein, the arm lymphatic drainage could keep balance and remain normal function. This arm lymphedema prediction model that included the protective factor, the proportion of arm lymph flow above the level of axillary vein, allows intraoperative intervention to be performed for the high-risk group. The arm lymphatics of these distinguished patients would be preserved to eliminate the occurrence of arm lymphedema in this study.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is developing a prediction tool (called a nomogram) to identify which breast cancer patients are most at risk of developing lymphedema — persistent arm swelling caused by damage to the lymphatic system during cancer surgery or treatment. The goal is to help doctors better predict and prevent this complication. **You may be eligible if you:** - Are 18 years of age or older - Have been diagnosed with T1–T3 invasive breast cancer - Had cancer that was confirmed in the lymph nodes before surgery - Underwent a mastectomy with a positive sentinel lymph node biopsy, OR breast-conserving surgery with more than two positive sentinel lymph nodes **You may NOT be eligible if you:** - Received chemotherapy before surgery (neoadjuvant chemotherapy) - Have a previous history of breast cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREAxillary surgery based on lymphedema prediction nomogram

Based on the intraoperative lymphedema prediction nomogram, individualized treatment was recommended to breast cancer patients with different level of risk. For patients with low possibility of developing breast cancer related lymphedema, it was not necessary to preserve arm lymphatics. While the breast cancer patients who were performed mastectomy and ALND with 28 kg/m2 prepared to receive taxane-based chemotherapy, supraclavicular and infraclavicular radiotherapy, according to the established intraoperative nomogram, the proportion of the arm lymph flow above the axillary vein needed to exceed 52%. Otherwise, the arm lymphatics should be identified and preserved.


Locations(1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

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NCT04665882


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