Breast Cancer Related Lymphedema Clinical Trial
— ELYBSOfficial title:
The Effectiveness of Lymphatic Bypass Supermicrosurgery for Primary Lymphedema Prevention After Breast Cancer Axillary Lymph Node Dissection: a Randomized Controlled Study
This study evaluate the effectiveness of lymphatic bypass supermicrosurgery (LBS) and axillary lymph node dissection (ALND) compare to ALND alone to prevent breast cancer treatment-related lymphedema (BCRL).
Status | Recruiting |
Enrollment | 140 |
Est. completion date | July 2024 |
Est. primary completion date | July 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Breast cancer patient aged >18 years old - Breast cancer patient with clinically ALNs metastases (cN1 or cN2). - Breast cancer patient with no clinical metastasis and tumor size =5cm or no sentinel lymph node biopsy facility in the hospital. - Any breast cancer patients that receive neoadjuvant systemic therapy. Exclusion Criteria: - Stage IV breast cancer patients who do not show clinical and radiological improvement after primary systemic therapy. - Breast cancer patients with previous surgeries such as mastectomy, axillary lymph node biopsy, sentinel lymph node biopsy (SLNB), and ALND. - Breast cancer patients with prior breast, chest wall, axillary, or neck radiotherapy. - Breast cancer patients with preoperative lymphatic system abnormality detected by ICG lymphography. - Breast cancer patients with iodine allergy, asthma, decreased kidney function, pregnancy, and lactation. |
Country | Name | City | State |
---|---|---|---|
Indonesia | Dharmais National Cancer Center Hospital | Jakarta |
Lead Sponsor | Collaborator |
---|---|
Dharmais National Cancer Center Hospital |
Indonesia,
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. — View Citation
Brahma B, Putri RI, Karsono R, Andinata B, Gautama W, Sari L, Haryono SJ. The predictive value of methylene blue dye as a single technique in breast cancer sentinel node biopsy: a study from Dharmais Cancer Hospital. World J Surg Oncol. 2017 Feb 7;15(1):41. doi: 10.1186/s12957-017-1113-8. — View Citation
Brahma B, Putri RI, Reuwpassa JO, Tuti Y, Alifian MF, Sofyan RF, Iskandar I, Yamamoto T. Lymphaticovenular Anastomosis in Breast Cancer Treatment-Related Lymphedema: A Short-Term Clinicopathological Analysis from Indonesia. J Reconstr Microsurg. 2021 Oct;37(8):643-654. doi: 10.1055/s-0041-1723940. Epub 2021 Mar 1. — View Citation
Brahma B, Yamamoto T. Breast cancer treatment-related lymphedema (BCRL): An overview of the literature and updates in microsurgery reconstructions. Eur J Surg Oncol. 2019 Jul;45(7):1138-1145. doi: 10.1016/j.ejso.2019.01.004. Epub 2019 Jan 4. — View Citation
Ishiura R, Yamamoto T, Saito T, Mito D, Iida T. Comparison of Lymphovenous Shunt Methods in a Rat Model: Supermicrosurgical Lymphaticovenular Anastomosis versus Microsurgical Lymphaticovenous Implantation. Plast Reconstr Surg. 2017 Jun;139(6):1407-1413. doi: 10.1097/PRS.0000000000003354. — View Citation
Suami H. Anatomical Theories of the Pathophysiology of Cancer-Related Lymphoedema. Cancers (Basel). 2020 May 23;12(5):1338. doi: 10.3390/cancers12051338. — View Citation
Yamamoto T, Narushima M, Yoshimatsu H, Yamamoto N, Kikuchi K, Todokoro T, Iida T, Koshima I. Dynamic Indocyanine Green (ICG) lymphography for breast cancer-related arm lymphedema. Ann Plast Surg. 2014 Dec;73(6):706-9. doi: 10.1097/SAP.0b013e318285875f. — View Citation
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. — View Citation
Yamamoto T, Yamamoto N, Hara H, Mihara M, Narushima M, Koshima I. Upper extremity lymphedema index: a simple method for severity evaluation of upper extremity lymphedema. Ann Plast Surg. 2013 Jan;70(1):47-9. doi: 10.1097/SAP.0b013e3182275d23. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Association of body mass index (BMI) with BCRL | BMI was calculated by weight (kilograms) and height (centimeters). Categorized based on Asia Pacific classification are overweight (BMI = 23 kg/m^2) and no overweight (BMI < 23 kg/m^2). Measured at one time point. | 1 year | |
Other | Association of number of axillary lymph nodes metastases with BCRL | The number of metastases lymph nodes and classified into >3 lymph nodes and =3 lymph nodes. Measured at one time point. | 1 year | |
Other | Association of number of taxane chemotherapy with BCRL | Taxane chemotherapy data from the subject's medical record and categorized into yes or no. Measured at one time point. | 1 year | |
Other | Association of regional lymph node radiation with BCRL | Regional lymph node radiation data from the subject's medical record and categorized into yes or no. Measured at one time point | 1 year | |
Other | Association of axillary fat weight with BCRL | Axillary fat weight in grams is taken at the time of surgery. Measured at one time point. | 1 year | |
Primary | Cumulative incidence of BCRL | BCRL definition:
Post operation subject condition with presence of minimum DB 2 with one or both symptoms (swelling, heaviness), and increment of UEL index >10% compared to pre operation OR Post operation subject condition with presence of = DB 2 with minimum area 30% in one arm region in one of the arm lymphatic pathway (anterior or posterior), without presence of symptoms (swelling or heaviness), and increment of UEL index >10% compared to pre operation |
1 year | |
Secondary | BCRL and SCL progression-free survival rate | Percentage of subjects who do not progress to subclinical lymphedema or lymphedema during the research. | 1 year | |
Secondary | Collateral lymphatic pathway | The number of lymphatic pathways flow into the region: supraclavicular, internal mammary, and contralateral axillary and supraclavicular nodes based on the ICG lymphography. | 1 year | |
Secondary | Quality of life lymphedema | Assessment of lymphedema quality of life score after the surgery using the lymphedema quality of life score questionnaire that is self-reported by the subjects every 2 months and every 3 months in the second year. Calculation of the lymphedema quality of life score is the summation of the score from each question. The minimum score is 0 and the maximum score is 100. A higher score indicates lower lymphedema quality of life. | 1 year |
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