Clinical trial NCT06095323: Comparing Level 1 Compression Sleeves With Routine Care in Preventing Breast Cancer-related Arm Lymphedema
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer-related Arm Lymphedema
Keywords: breast cancer-related arm lymphedema
bioimpedance spectroscopy
Limb circumference measurement
Lead sponsor: Henan Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2023-10-23
Enrollment: 480
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. Patients aged 18 to 70 years old
2. Breast cancer, unilateral，Patients undergoing axillary lymph node dissection
3. Patients voluntarily joined the study and signed informed consent

Exclusion Criteria:

1. arm swelling preoperatively, as assessed by bioimpedance spectroscopy (BIS) or Limb circumference measurement
2. any condition that hindered them from wearing a compression sleeve
3. Patients with upper limb dysfunction before surgery, including shoulder and elbow joint mobility disorders
4. Patients with mental disorders, senile dementia, and cognitive impairments，were not able to complete a questionnaire independently
5. Patients with bilateral breast cancer, recurrence, or metastasis to other organs.

Primary outcomes:
measure: Incidence of arm lymphedema 2 years after surgery: as assessed by bioimpedance spectroscopy (BIS)
timeFrame: Preoperatively ，postoperatively 3、6、9、12、18、24 month
Secondary outcomes:
measure: Incidence of arm lymphedema 2 years after surgery: as assessed by circumferential diameter measureme
timeFrame: Preoperatively ，postoperatively 3、6、9、12、18、24 month
measure: the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and the breast cancer-specific (BR23) questionnaire
timeFrame: Preoperatively ，postoperatively 3、6、9、12、18、24 month
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
Study officials:
affiliation: Henan Cancer Hospital
name: Zhenzhen Liu
role: PRINCIPAL_INVESTIGATOR
References: