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

Z

Zhenzhen Liu

Status

Enrolling

Conditions

Breast Cancer-related Arm Lymphedema

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT06095323
HNCH-BCRL001

Details and patient eligibility

About

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.

Full 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.

Enrollment

480 estimated patients

Sex

Female

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

480 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Zhenzhen Liu

Data sourced from clinicaltrials.gov

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