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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer-related Arm Lymphedema
• Intervention / Treatment: Device: compression sleeves for upper limbs with a pressure level of 1 (15-20mmHg)

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.

• Study Type: Interventional
• Enrollment (Estimated): 480
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhenzhen Liu; Phone Number: 13603862755; Email: liuzhenzhen73@126.com

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450008
      • Recruiting
      • Henan Cancer Hospital
      • Contact: Guo XuHui; Phone Number: 13526611597; Email: guoxuhui1980@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Zhenzhen Liu
• Investigators: Principal Investigator: Zhenzhen Liu, Henan Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2023
• Primary Completion (Estimated): October 16, 2025
• Study Completion (Estimated): October 16, 2025

Study Registration Dates

• First Submitted: October 8, 2023
• First Submitted That Met QC Criteria: October 18, 2023
• First Posted (Actual): October 23, 2023

Study Record Updates

• Last Update Posted (Actual): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: bioimpedance spectroscopy; breast cancer-related arm lymphedema; Limb circumference measurement
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms; Lymphatic Diseases; Neoplasms by Site; Postoperative Complications; Breast Diseases; Breast Neoplasms; Lymphedema; Breast Cancer Lymphedema
• Other Study ID Numbers: HNCH-BCRL001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No