NCT06095323

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

Status unknown NA Last updated 20 December 2023

What this trial tests

NA trial testing compression sleeves for upper limbs with a pressure level of 1 (15-20mmHg) in Breast Cancer-related Arm Lymphedema in 480 participants. Status unknown.

Timeline

16 October 2023

Primary endpoint
16 October 2025

16 October 2025

Quick facts

Lead sponsor	Zhenzhen Liu
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	480
Start date	16 October 2023
Primary completion	16 October 2025
Estimated completion	16 October 2025
Sites	1 location across China

Drugs / interventions tested

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

Conditions studied

• Breast Cancer-related Arm Lymphedema — all drugs for Breast Cancer-related Arm Lymphedema →

Sponsor

Zhenzhen Liu — full company profile →

Who can join

Adults 18 to 70, female only, with Breast Cancer-related Arm Lymphedema. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.