Trial Title:
Comparing Level 1 Compression Sleeves With Routine Care in Preventing Breast Cancer-related Arm Lymphedema
NCT ID:
NCT06095323
Condition:
Breast Cancer-related Arm Lymphedema
Conditions: Official terms:
Breast Neoplasms
Lymphedema
Breast Cancer Lymphedema
Conditions: Keywords:
breast cancer-related arm lymphedema
bioimpedance spectroscopy
Limb circumference measurement
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
compression sleeves for upper limbs with a pressure level of 1 (15-20mmHg)
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.
Arm group label:
Prophylactic compression sleeves group
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.
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.
Criteria for eligibility:
Criteria:
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Zip:
450008
Country:
China
Status:
Recruiting
Contact:
Last name:
Guo XuHui
Phone:
13526611597
Email:
guoxuhui1980@qq.com
Start date:
October 16, 2023
Completion date:
October 16, 2025
Lead sponsor:
Agency:
Zhenzhen Liu
Agency class:
Other
Source:
Henan Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06095323
