Assessment of Breast Cancer-Related Arm Lymphedema

NCT ID: NCT03978754

Last Updated: 2021-12-07

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-10-01
• Study Completion Date: 2022-01-31

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.

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.

Conditions

Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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）

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

Intervention Type: DIAGNOSTIC_TEST

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

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）

Bioelectrical impedance technology、CM

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Bioelectrical impedance technology、CM

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

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

ICG: indocyanine green; CM: circumference measurement; VD: volume displacement; CM: circumference measurement

Eligibility Criteria

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.

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

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:

• 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.

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Peking University People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wang Shu

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital

Locations

Peking University People's Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

liu siyao

Role: CONTACT

dr.liusiyao@pku.edu.cn

+86 18801229921

Facility Contacts

liu siyao

Role: primary

doc_lsy@163.com

+86 18801229921

References

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.

Reference Type: BACKGROUND

PMID: 32256375 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32521126 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19916749 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29650264 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21681123 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27465179 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16569209 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24354107 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19082708 (View on PubMed)

Other Identifiers

PUPH18050101

Identifier Type: -

Identifier Source: org_study_id