Assessment of Breast Cancer-Related Arm Lymphedema

NCT03978754 | Unknown

• 1 other identifier: PUPH18050101
• Study Type: observational
• Target: 1,600
• Locations: 1 country
• Sites: 1

Brief 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

Breast Cancer

Keywords

Lymphedema; Breast cancer; ICG lymphography; Bioelectrical impedance technology

Outcome Measures

Primary Outcomes (4)

• Sensitivity and specificity of indocyanine green (ICG) lymphography

  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

  The incidence of lymphedema assessed by different methods when patients first visit clinic

  2017-2022

• The cutoff value of BIS

  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

  Patients who don't develop lymphedema when the first visit to the lymphedema clinic, the occurrence of lymphedema after follow-up.

  2017-2022

Study Arms (2)

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

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

Interventions

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

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

Also known as: ICG: indocyanine green, CM: circumference measurement, VD: volume displacement

Patients who visit clinic

Bioelectrical impedance technology、CM DIAGNOSTIC_TEST

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

Also known as: CM: circumference measurement

Preoperative breast cancer patients

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, China

RECRUITING

Related Publications (9)

• Azhar SH, Lim HY, Tan BK, Angeli V. The Unresolved Pathophysiology of Lymphedema. Front Physiol. 2020 Mar 17;11:137. doi: 10.3389/fphys.2020.00137. eCollection 2020.

  PMID: 32256375 BACKGROUND

• Executive Committee of the International Society of Lymphology. The diagnosis and treatment of peripheral lymphedema: 2020 Consensus Document of the International Society of Lymphology. Lymphology. 2020;53(1):3-19.

  PMID: 32521126 BACKGROUND

• Czerniec SA, Ward LC, Refshauge KM, Beith J, Lee MJ, York S, Kilbreath SL. Assessment of breast cancer-related arm lymphedema--comparison of physical measurement methods and self-report. Cancer Invest. 2010 Jan;28(1):54-62. doi: 10.3109/07357900902918494.

  PMID: 19916749 BACKGROUND

• Qin ES, Bowen MJ, Chen WF. Diagnostic accuracy of bioimpedance spectroscopy in patients with lymphedema: A retrospective cohort analysis. J Plast Reconstr Aesthet Surg. 2018 Jul;71(7):1041-1050. doi: 10.1016/j.bjps.2018.02.012. Epub 2018 Apr 9.

  PMID: 29650264 BACKGROUND

• Yamamoto T, Yamamoto N, Doi K, Oshima A, Yoshimatsu H, Todokoro T, Ogata F, Mihara M, Narushima M, Iida T, Koshima I. Indocyanine green-enhanced lymphography for upper extremity lymphedema: a novel severity staging system using dermal backflow patterns. Plast Reconstr Surg. 2011 Oct;128(4):941-947. doi: 10.1097/PRS.0b013e3182268cd9.

  PMID: 21681123 BACKGROUND

• Akita S, Nakamura R, Yamamoto N, Tokumoto H, Ishigaki T, Yamaji Y, Sasahara Y, Kubota Y, Mitsukawa N, Satoh K. Early Detection of Lymphatic Disorder and Treatment for Lymphedema following Breast Cancer. Plast Reconstr Surg. 2016 Aug;138(2):192e-202e. doi: 10.1097/PRS.0000000000002337.

  PMID: 27465179 BACKGROUND

• Ward LC. Bioelectrical impedance analysis: proven utility in lymphedema risk assessment and therapeutic monitoring. Lymphat Res Biol. 2006 Spring;4(1):51-6. doi: 10.1089/lrb.2006.4.51. No abstract available.

  PMID: 16569209 BACKGROUND

• Fu MR, Cleland CM, Guth AA, Kayal M, Haber J, Cartwright F, Kleinman R, Kang Y, Scagliola J, Axelrod D. L-dex ratio in detecting breast cancer-related lymphedema: reliability, sensitivity, and specificity. Lymphology. 2013 Jun;46(2):85-96.

  PMID: 24354107 BACKGROUND

• Ward LC, Czerniec S, Kilbreath SL. Quantitative bioimpedance spectroscopy for the assessment of lymphoedema. Breast Cancer Res Treat. 2009 Oct;117(3):541-7. doi: 10.1007/s10549-008-0258-0. Epub 2008 Dec 11.

  PMID: 19082708 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Lymphedema

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Wang Shu

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

liu siyao

CONTACT

+86 18801229921; dr.liusiyao@pku.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2019
• First Posted: June 7, 2019
• Study Start: October 1, 2017
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: December 7, 2021

Record last verified: 2021-11

Locations

CN (1)