Assessment of Breast Cancer-Related Arm Lymphedema

November 23, 2021 updated by: Peking University People's Hospital

Assessment of Breast Cancer-Related Arm Lymphedema-Comparison of Traditional Measurement Methods and Indocyanine Green（ICG）Lymphography

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Breast cancer is a common malignant disease that threatens the health of women. As a serious complication of breast cancer treatment, lymphedema is caused by chronic accumulation of lymph fluid in the interstitial spaces of the affected limb or surrounding areas. Reported prevalence of lymphedema following treatment for breast cancer varies, ranging from 7-45%. One 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Recruiting
        • Peking University People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Group1: Patients who visit the clinic; Group2: Preoperative subjects diagnosed with breast cancer.

Description

The eligibility criteria for patients who visit the clinic:

Inclusion Criteria:

  • Patients with breast cancer who underwent axillary surgery.
  • Patients who have complaints about upper extremity lymphedema and are willing to undergo examination.
  • Sign the informed consent.

Exclusion Criteria:

  • Bilateral breast cancer.
  • A history of allergy to contrast agents.
  • There are arteriovenous thrombosis in the affected limb.
  • Regional lymph node recurrence
  • Did not sign informed consent.
  • Serious heart, brain and other diseases.
  • The primary lymphatic system diseases (such as lymphatic leakage).
  • Only one side of the limb received ICG angiography.

The eligibility criteria for preoperative subjects diagnosed with breast cancer:

Inclusion Criteria:

• Preoperative subjects diagnosed with breast cancer at our breast center.

Exclusion Criteria:

• We strictly excluded all possible causes of lymphedema. Subjects whose clinical stage of lymph node is N2 or higher were excluded. Subjects with lymphedema -related diseases or kidney disease, inflammatory breast cancer, a history of axillary surgery, radiotherapy to the upper limbs or the chest wall, soft tissue infection, pregnancy, congestive heart-failure, administration of diuretics (which may have significantly changed the hydration status) and implanted devices (e.g., pacemakers), were also excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Patients who visit clinic
Postoperative patients who have undergone axillary surgery for breast cancer and went to clinic due to complaints of upper limb discomfort.（The expected number of subjects in this group is 300）
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.
Other Names:
  • ICG: indocyanine green
  • CM: circumference measurement
  • VD: volume displacement
Preoperative breast cancer patients
Preoperative subjects diagnosed with breast cancer were enrolled as non-lymphedema group. （The expected number of subjects in this group is 1300）
Diagnostic test: Bioelectrical impedance technology、CM
These two methods are routine evaluation methods for breast cancer patients before surgery
Other Names:
  • CM: circumference measurement

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Sensitivity and specificity of indocyanine green (ICG) lymphography
Time Frame: 2017-2022
Sensitivity means the ability of detecting patients with true lymphedema. Specificity means the ability of detecting non-lymphedema patients.
2017-2022
The incidence of lymphedema
Time Frame: 2017-2022
The incidence of lymphedema assessed by different methods when patients first visit clinic
2017-2022
The cutoff value of BIS
Time Frame: 2017-2022
studies on the threshold value established by Inbody 720 device have been extremely limited. We aimed to determine its reference range and cutoff values.
2017-2022
The occurrence of lymphedema after follow-up
Time Frame: 2017-2022
Patients who don't develop lymphedema when the first visit to the lymphedema clinic, the occurrence of lymphedema after follow-up.
2017-2022

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking University People's Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Wang Shu, Peking University People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 23, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 7, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 7, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 23, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PUPH18050101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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