Breast Cancer Related Lymphedema, Lymphedema Arm
Conditions
Keywords
Lymphatic Bypass Supermicrosurgery, Primary Lymphedema Prevention, Axillary Lymph Node Dissection
Brief summary
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).
Detailed description
In the intervention group, LBS was performed after ALND with the intima-to-intima coaptation using the supermicrosurgery technique. The anastomosis is done between the afferent lymphatic vessel to the recipient's vein, or if possible, from the afferent to the efferent lymphatic vessel. The upper extremity lymphedema (UEL) index and indocyanine green (ICG) lymphography are utilized to evaluate the development of lymphedema.
Interventions
PROCEDURELymphatic Bypass Supermicrosurgery
Axillary Lymph Node Dissection with Lymphatic Bypass Supermicrosurgery
Sponsors
Dharmais National Cancer Center Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
Blinding is implemented in two conditions: the main researcher (Bayu Brahma) will not know the identity and medical history of the patient when assessing the indocyanine green (ICG) lymphography results and the patients will not know the received type of surgical procedure.
Intervention model description
This study is a single-blind pragmatic parallel arm randomized clinical trial to analyze the effectiveness of lymphatic bypass supermicrosurgery (LBS).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative incidence of BCRL | 1 year | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BCRL and SCL progression-free survival rate | 1 year | Percentage of subjects who do not progress to subclinical lymphedema or lymphedema during the research. |
| Collateral lymphatic pathway | 1 year | The number of lymphatic pathways flow into the region: supraclavicular, internal mammary, and contralateral axillary and supraclavicular nodes based on the ICG lymphography. |
| Quality of life lymphedema | 1 year | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Association of body mass index (BMI) with BCRL | 1 year | 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. |
| Association of axillary fat weight with BCRL | 1 year | Axillary fat weight in grams is taken at the time of surgery. Measured at one time point. |
| Association of number of axillary lymph nodes metastases with BCRL | 1 year | The number of metastases lymph nodes and classified into \>3 lymph nodes and ≤3 lymph nodes. Measured at one time point. |
| Association of number of taxane chemotherapy with BCRL | 1 year | Taxane chemotherapy data from the subject's medical record and categorized into yes or no. Measured at one time point. |
| Association of regional lymph node radiation with BCRL | 1 year | Regional lymph node radiation data from the subject's medical record and categorized into yes or no. Measured at one time point |
Countries
Indonesia
Outcome results
None listed