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Assessment of Breast Cancer-Related Arm Lymphedema

NCT03978754 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1600

Last updated 2021-12-07

No results posted yet for this study

Summary

Lymphedema is a serious complication of breast cancer treatment. Reported prevalence of lymphedema following treatment for breast cancer varies, ranging from 7-45%. The reason for the wide variation in the reported incidence of lymphedema is the different measurement techniques used and the absence of an agreed diagnostic criteria. Nowadays, the common method include limb circumference measurement、volume measurement、bioimpedance spectroscopy (BIS) and self-report. Each of these methods has advantages and disadvantages. A variety of publications have demonstrated the ability of bioimpedance to diagnose subclinical lymphedema. As a new method for detecting lymphedema, some study have also shown indocyanine green（ICG）lymphography can have a certain value for the detection of subclinical lymphedema. Early detection can reduce the incidence of late-stage lymphedema in postoperative patients. Therefore, we want to explore the ability of these methods. We are going to perform baseline arm circumference measurements and bioelectrical impedance measurements for all preoperative breast cancer patients in our center. In addition, the arm circumference measurement、volume measurement、bioimpedance spectroscopy (BIS) 、self-report and indocyanine green (ICG) lymphography will be performed on patients who go to the lymphedema clinic after breast cancer surgery. First, we want to establish the threshold and reference value range based on the impedance value of patients with lymphedema and people without lymphedema.Second, we are going to examine the relationship between the most commonly used methods of lymphedema and also to test which method is more sensitive for the diagnosis of clinical and subclinical lymphedema. Finally, we want to explore the ability of ICG lymphography in detecting sub-clinical lymphedema.

Conditions

Interventions

DIAGNOSTIC_TEST

ICG lymphography、CM、VD、Bioelectrical impedance technology、self-report

All of these methods are used for patients visiting the lymphedema clinic to assess whether they have developed lymphedema.

DIAGNOSTIC_TEST

Bioelectrical impedance technology、CM

These two methods are routine evaluation methods for breast cancer patients before surgery

Sponsors & Collaborators

  • Peking University People's Hospital

    lead OTHER

Principal Investigators

  • Wang Shu · Peking University People's Hospital

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-01
Primary Completion
2022-01-31
Completion
2022-01-31

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03978754 on ClinicalTrials.gov