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

Last updated: December 18, 2023
Sponsor: Zhenzhen Liu
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lymphedema

Treatment

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

Clinical Study ID

NCT06095323
HNCH-BCRL001
  • Ages 18-70
  • Female

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  1. arm swelling preoperatively, as assessed by bioimpedance spectroscopy (BIS) or Limbcircumference measurement
  2. any condition that hindered them from wearing a compression sleeve
  3. Patients with upper limb dysfunction before surgery, including shoulder and elbowjoint mobility disorders
  4. Patients with mental disorders, senile dementia, and cognitive impairments，were notable to complete a questionnaire independently
  5. Patients with bilateral breast cancer, recurrence, or metastasis to other organs.

Study Design

Total Participants: 480
Treatment Group(s): 1
Primary Treatment: compression sleeves for upper limbs with a pressure level of 1 (15-20mmHg)
Phase:
Study Start date:
October 16, 2023
Estimated Completion Date:
October 16, 2025

Study 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.

Connect with a study center

  • Henan Cancer Hospital

    Zhengzhou, Henan 450008
    China

    Active - Recruiting

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