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NCT Number: NCT04665882

Nomogram to Predict Breast Cancer Related Lymphedema

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.

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Key information

Conditions

Breast Cancer Axillary Lymph Node Dissection Axillary Reverse Mapping Breast Cancer Lymphedema Breast Cancer Related Lymphedema Breast Diseases Breast Neoplasms Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430071, China

Location status: Recruiting

Location contact

Qianqian Yuan, MD.

CONTACT

[email protected]

+8613026322297

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged 18 years or older with T1-3 invasive breast cancer;
  • Clinically node-positive breast cancer, defined as positive on preoperative axillary palpation, ultrasound examination, and computed tomography scan with contrast;
  • Patients who underwent mastectomy with a positive sentinel lymph node (SLN);
  • Patients who underwent breast-conserving surgery containing more than two positive SLNs.

Exclusion criteria

  • Neoadjuvant chemotherapy;
  • Previous history of breast cancer.

Treatment and study plan

Axillary surgery based on lymphedema prediction nomogram

Procedure

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.

Primary outcomes

  1. Rate of arm lymphedema

    Time frame: Up to 5 years

    A difference in volume between the arms < 10% was defined as lymphedema

  2. Rate of locoregional recurrence

    Time frame: Up to 5 years

    Locoregional recurrence included local recurrence and regional recurrence. Local recurrence was defined as chest wall recurrence of breast cancer, and regional recurrence was defined as the axilla recurrence of breast cancer

  3. Rate of distant metastasis

    Time frame: Up to 5 years

    Cancer cells from breast metastasized to other organs.

Study contacts

Contact information is provided by the study sponsor or research team.

Qianqian Yuan, M.D.

CONTACT

[email protected]

13026322297

Sponsors and collaborators

Lead sponsor

Wuhan University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2027
First posted
Dec 14, 2020
Registry last updated
Dec 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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