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

NCT06095323 | Unknown

• 1 other identifier: HNCH-BCRL001
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer-related Arm Lymphedema

Keywords

breast cancer-related arm lymphedema; bioimpedance spectroscopy; Limb circumference measurement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Incidence of arm lymphedema 2 years after surgery: as assessed by circumferential diameter measureme

  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

  Preoperatively ，postoperatively 3、6、9、12、18、24 month

Study Arms (2)

Prophylactic compression sleeves group

EXPERIMENTAL

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)

routine care group

NO INTERVENTION

The routine care group will proceed as an observation and receive standard lymphedema education during the clinical trial.

Interventions

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

The intervention group will wear compression sleeves for upper limbs with a pressure level of 1 (15-20mmHg) during the day for 12 months.

Prophylactic compression sleeves group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhenzhen Liu: lead

Study Sites (1)

Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

RECRUITING

MeSH Terms

Conditions

Breast Cancer Lymphedema

Condition Hierarchy (Ancestors)

Lymphedema; Lymphatic Diseases; Hemic and Lymphatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Zhenzhen Liu

  Henan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhenzhen Liu

CONTACT

13603862755; liuzhenzhen73@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: liuzhenzhen73@126.com

Study Record Dates

• First Submitted: October 8, 2023
• First Posted: October 23, 2023
• Study Start: October 16, 2023
• Primary Completion: October 16, 2025
• Study Completion: October 16, 2025
• Last Updated: December 20, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)