Breast Cancer-related Arm LymphedemaNCT06095323
Comparing Level 1 Compression Sleeves With Routine Care in Preventing Breast Cancer-related Arm Lymphedema
A study testing compression sleeves for upper limbs with a pressure level of 1 (15-20mmHg) in people with Breast Cancer-related Arm Lymphedema, run by Zhenzhen Liu at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer-related Arm Lymphedema
- What is being tested?
- compression sleeves for upper limbs with a pressure level of 1 (15-20mmHg)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 1 siteChina
- Study dates
- 16 Oct 2023to 16 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450008
Guo XuHui, 13526611597, guoxuhui1980@qq.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer-related Arm Lymphedema
- Being tested
- compression sleeves for upper limbs with a pressure level of 1 (15-20mmHg)
- Keywords
- breast cancer-related arm lymphedema, bioimpedance spectroscopy, Limb circumference measurement
- Medical subject headings
- Breast Cancer Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: Preoperatively ，postoperatively 3、6、9、12、18、24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start16 Oct 2023
- Primary completion16 Oct 2025 (estimated)
- Study completion16 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer-related Arm LymphedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhenzhen Liu
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Zhenzhen Liu, Henan Cancer Hospital
- Investigators
- Zhenzhen Liu, Principal investigator, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06095323
- Sponsor's protocol ID
- HNCH-BCRL001
- Status last verified
- Dec 2023
- First submitted
- 8 Oct 2023
- Last updated
- 20 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06095323
- Acronym / sponsor ID
- HNCH-BCRL001
- Conditions
- Breast Cancer-related Arm Lymphedema
- Keywords
- breast cancer-related arm lymphedema, bioimpedance spectroscopy, Limb circumference measurement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Zhenzhen LiuOther government
- Study start
- 16 Oct 2023 (actual)
- Primary completion
- 16 Oct 2025 (estimated)
- Study completion
- 16 Oct 2025 (estimated)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prophylactic compression sleeves group | Experimental | 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. |
| routine care group | No intervention | –The routine care group will proceed as an observation and receive standard lymphedema education during the clinical trial. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Prophylactic compression sleeves group |
Primary outcome
Incidence of arm lymphedema 2 years after surgery: as assessed by bioimpedance spectroscopy (BIS)
Time frame: Preoperatively ，postoperatively 3、6、9、12、18、24 month
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.
2 secondary outcomes
Incidence of arm lymphedema 2 years after surgery: as assessed by circumferential diameter measureme
Time frame: 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
Time frame: Preoperatively ，postoperatively 3、6、9、12、18、24 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhenzhen Liu principal investigator
Henan Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing compression sleeves for upper limbs with a pressure level of 1 (15-20mmHg) in people with Breast Cancer-related Arm Lymphedema, run by Zhenzhen Liu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhenzhen Liu (13603862755, liuzhenzhen73@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of arm lymphedema 2 years after surgery: as assessed by bioimpedance spectroscopy (BIS) (time frame: Preoperatively ，postoperatively 3、6、9、12、18、24 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2023.