Comparing Level 1 Compression Sleeves With Routine Care in Preventing Breast Cancer-related Arm Lymphedema

Study Overview
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Brief Summary
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It is estimated that there are 420,000 newly diagnosed breast cancer patients in China in 2020. With surgery, radiotherapy, chemotherapy, endocrine, targeted therapy and other treatment methods going hand in hand, the outcome of breast cancer patients has been greatly improved. However, along with the comprehensive treatment of breast cancer, there will also be some corresponding complications, including breast cancer-related lymphedema （BCRL）， is one of the most common and serious complications. the incidence of BCRL in the patients with axillary dissection11% -57%, average 28%, Arm lymphedema seriously affect the quality of life of breast cancer patients, is known as the last kilometer of breast cancer patients to return to society. The related risk factors mainly include surgery, radiotherapy, body mass index, (BMI), etc. Accordingly, a series of measures appeared to prevent the occurrence of BCRL, including surgical and non-surgical methods, The main surgical methods include lymphatic microsurgical preventing healing approach (LYMPHA), and axillary reverse mapping to retain arm lymph nodes.the LYMPHA technology requires skilled microsurgery technology, or multidisciplinary participation, which will prolong the operation time.The retention of arm lymph nodes may involve tumor safety.Non-surgical methods include elastic sleeve wearing, functional exercise, arm resistance training, manual drainage, etc. The manual drainage is time-consuming and requires therapist participation, and the evidence that resistance training can prevent edema is insufficient.The elastic cuff has been proven to effectively prevent the occurrence of BCRL, and it can prevent the accumulation of extracellular fluid caused by surgery, chemotherapy and radiation therapy, and gravity factors. A randomized controlled study (CTRI / 2017 / 12 / 010762) released by Paramanandam VS et al, Tata Memorial Hospital, tertiary Cancer Center, Mumbai, India, that wearing compression sleeves (20-25mmHg) can reduce and delay the occurrence of arm swelling in the first year after breast cancer surgery. However, the higher pressure sleeves still has a negative impact on patients' quality of life and patient compliance. Ochalek K have shown that the primary pressure sleeves (15-20mmHg) is also effective in preventing the occurrence of lymphedema, but the randomized controlled study has a small sample size and insufficient evidence.

Detailed Description
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It is estimated that there are 420,000 newly diagnosed breast cancer patients in China in 2020. With surgery, radiotherapy, chemotherapy, endocrine, targeted therapy and other treatment methods going hand in hand, the outcome of breast cancer patients has been greatly improved. However, along with the comprehensive treatment of breast cancer, there will also be some corresponding complications, including breast cancer-related lymphedema （BCRL）， is one of the most common and serious complications. the incidence of BCRL in the patients with axillary dissection11% -57%, average 28%, Arm lymphedema seriously affect the quality of life of breast cancer patients, is known as the last kilometer of breast cancer patients to return to society. The related risk factors mainly include surgery, radiotherapy, body mass index, (BMI), etc. Accordingly, a series of measures appeared to prevent the occurrence of BCRL, including surgical and non-surgical methods, The main surgical methods include lymphatic microsurgical preventing healing approach (LYMPHA), and axillary reverse mapping to retain arm lymph nodes.the LYMPHA technology requires skilled microsurgery technology, or multidisciplinary participation, which will prolong the operation time.The retention of arm lymph nodes may involve tumor safety.Non-surgical methods include elastic sleeve wearing, functional exercise, arm resistance training, manual drainage, etc. The manual drainage is time-consuming and requires therapist participation, and the evidence that resistance training can prevent edema is insufficient.The elastic cuff has been proven to effectively prevent the occurrence of BCRL, and it can prevent the accumulation of extracellular fluid caused by surgery, chemotherapy and radiation therapy, and gravity factors. A randomized controlled study (CTRI / 2017 / 12 / 010762) released by Paramanandam VS et al, Tata Memorial Hospital, tertiary Cancer Center, Mumbai, India, that wearing compression sleeves (20-25mmHg) can reduce and delay the occurrence of arm swelling in the first year after breast cancer surgery. However, the higher pressure sleeves still has a negative impact on patients' quality of life and patient compliance. Ochalek K have shown that the primary pressure sleeves (15-20mmHg) is also effective in preventing the occurrence of lymphedema, but the randomized controlled study has a small sample size and insufficient evidence. This study aims to compare level 1 compression sleeves with routine care in preventing breast cancer-related arm lymphedema after axillary lymph node dissection through a randomized controlled trial.

Official Title
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Comparing Level 1 Compression Sleeves With Routine Care in Preventing Breast Cancer-related Arm Lymphedema :An Open-label, Single-center, Randomized Controlled Phase II Clinical Trial

Conditions
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Breast Cancer-related Arm Lymphedema

Intervention / Treatment
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* Device: compression sleeves for upper limbs with a pressure level of 1 (15-20mmHg)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 18 to 70 years old Breast cancer, unilateral，Patients undergoing axillary lymph node dissection Patients voluntarily joined the study and signed informed consent Exclusion Criteria: arm swelling preoperatively, as assessed by bioimpedance spectroscopy (BIS) or Limb circumference measurement any condition that hindered them from wearing a compression sleeve Patients with upper limb dysfunction before surgery, including shoulder and elbow joint mobility disorders Patients with mental disorders, senile dementia, and cognitive impairments，were not able to complete a questionnaire independently Patients with bilateral breast cancer, recurrence, or metastasis to other organs.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prophylactic compression sleeves group<br>The intervention group will wear compression sleeves for upper limbs with a pressure level of 1 (15-20mmHg) during the day for 12 months. | Device: compression sleeves for upper limbs with a pressure level of 1 (15-20mmHg)<br>* The intervention group will wear compression sleeves for upper limbs with a pressure level of 1 (15-20mmHg) during the day for 12 months.<br>|
| No Intervention: routine care group<br>The routine care group will proceed as an observation and receive standard lymphedema education during the clinical trial. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of arm lymphedema 2 years after surgery: as assessed by bioimpedance spectroscopy (BIS) | Incidence of arm lymphedema 2 years after surgery: as assessed by bioimpedance spectroscopy (BIS), bilateral upper limb impedance ratio, bilateral upper limb impedance ratio compared with the first baseline, if the inter-arm ratio exceeds the threshold, the individual is classified as arm lymphedema . If the surgical side is the dominant hand, the inter-arm impedance ratio threshold is 1.108; if the non-dominant hand is used, the inter-arm impedance ratio threshold is 1.072. | Preoperatively ，postoperatively 3、6、9、12、18、24 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of arm lymphedema 2 years after surgery: as assessed by circumferential diameter measureme | Arm vol-ume was determined from circumference measurements,commencing at the ulnar styloid and at 10-cm intervals proximally to 40 cm using an inelastic tape measure; measurements were recorded to the nearest 1.0 mm. Each arm's volume was calculated using the truncated cone formula from the arm circumference measurements.Relative (percentage) arm volume differences between the at-risk and unaffected arms were then calculated, and cases in which the relative arm volume increased 10% from baseline were identified. | Preoperatively ，postoperatively 3、6、9、12、18、24 month | 
| the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and the breast cancer-specific (BR23) questionnaire | the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and the breast cancer-specific (BR23) questionnaire was analyzed. | Preoperatively ，postoperatively 3、6、9、12、18、24 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer-related arm lymphedema, bioimpedance spectroscopy, Limb circumference measurement