Breast CancerNCT06495034
Airwave Compression Therapy to Prevent Breast Cancer-related Lymphedema
A study testing airwave compression therapy in people with Breast Cancer, run by Shantou Central Hospital at 1 site in China.
Trial summary
This study aims to explore the effectiveness of early intervention of airwave compression therapy to prevent the occurrence of postoperative breast cancer-related lymphedema(BCRL). Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- airwave compression therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2023to 30 Jun 2026
- 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
- Volunteer to participate in this clinical trial. Fully understand and be informed about the study and sign an informed consent form (ICF). Willing to follow and able to complete all test procedures;
- Female, ≥18 years old and ≤70 years old at the time of signing the ICF;
- Patients with unilateral breast cancer diagnosed by histopathology or cytology;
- No distant metastasis;
- To undergo unilateral axillary sentinel lymph node biopsy or unilateral axillary lymph node dissection;
- Have not received any treatment for arm lymphedema;
- No lymphangitis and other infections.
Who cannot join
- Breast malignancy derived from other tumors rather than the primary breast cancer;
- Patients with second primary tumor;
- Contraindication to airwave compression therapy: Acute venous thrombosis; Acute inflammatory skin disease; Erysipelas; Arrhythmia; Pulmonary edema; Unstable hypertension; People with artificial pacemakers; Deep thrombophlebitis;
- Have a history of mental illness or other reasons can not cooperate with treatment;
- Embolism, cardiogenic edema, hepatogenic edema and the history of upper limb trauma and other related complications;
- Patients using any medication that affects fluid or electrolyte balance.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shantou Central Hospital
Shantou, Guangdong, 510000
Wan-Lin Zhan, Dr., 008619830233390, 287822522@qq.com
About this study
Official title: A Randomized Controlled Study on Early Intervention of Airwave Compression Therapy to Prevent Breast Cancer-related Upper Limb Lymphedema
This study aims to explore the effectiveness of early intervention of airwave compression therapy to prevent the occurrence of postoperative breast cancer-related lymphedema(BCRL).
Read the detailed description
This study aims to explore the effectiveness of early intervention of airwave compression therapy to prevent the occurrence of postoperative breast cancer-related lymphedema (BCRL), hereby improving the quality of life of patients with breast cancer. Furthermore, we will perform exploratory analyses to investigate the predictive values of patient plasma cytokines to the occurrence and development of BCRL.
- Conditions
- Breast Cancer
- Being tested
- airwave compression therapy, standard care: health education and routine functional exercise
- Keywords
- breast cancer-related lymphedema, airwave compression therapy, quality of life
- Medical subject headings
- Breast Neoplasms, Breast Cancer Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
airwave compression therapyDevice
Also called Airwave pressure therapy，intermittent pneumatic compression pump，IPC
Airwave compression therapy was given to patients after breast cancer surgery to treat the ipsilateral upper limb
standard care: health education and routine functional exerciseOther
standard care: health education and routine functional exercise
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | standard care: health education and routine functional exercise Receives: Other: standard care: health education and routine functional exercise |
| experimental group | Experimental | 1. standard care: health education and routine functional exercise;
2. airwave compression therapy Receives: Device: airwave compression therapy; Other: standard care: health education and routine functional exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of lymphedema
Incidence of lymphedema of ipsilateral upper limb
Measured: 18 months
Secondary outcomes (2)
Symptoms
Questionnaire. The level of subjective symptoms( pain, heaviness, paresthesia) at each time point was recorded with a 0-3 four-point scale questionnaire. 0-3 indicated no symptoms, mild, moderate, and severe, respectively.
Measured: 18 months
Quality of life assessment
FACT-B (V4.0)
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start1 Jul 2023
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shantou Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Si-Qi Qiu, Shantou Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06495034
- Sponsor's protocol ID
- ShantouCH003
- Status last verified
- Jul 2024
- First submitted
- 1 Jul 2024
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- 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 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study on Early Intervention of Airwave Compression Therapy to Prevent Breast Cancer-related Upper Limb Lymphedema
- ClinicalTrials.gov ID
- NCT06495034
- Acronym / sponsor ID
- ShantouCH003
- Conditions
- Breast Cancer
- Keywords
- breast cancer-related lymphedema, airwave compression therapy, quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Shantou Central HospitalUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 10 Jul 2024 (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.
This study aims to explore the effectiveness of early intervention of airwave compression therapy to prevent the occurrence of postoperative breast cancer-related lymphedema(BCRL).
Detailed description
This study aims to explore the effectiveness of early intervention of airwave compression therapy to prevent the occurrence of postoperative breast cancer-related lymphedema (BCRL), hereby improving the quality of life of patients with breast cancer. Furthermore, we will perform exploratory analyses to investigate the predictive values of patient plasma cytokines to the occurrence and development of BCRL.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Other: standard care: health education and routine functional exercisestandard care: health education and routine functional exercise |
| experimental group | Experimental | Device: airwave compression therapy, Other: standard care: health education and routine functional exercise1. standard care: health education and routine functional exercise; 2. airwave compression therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Volunteer to participate in this clinical trial. Fully understand and be informed about the study and sign an informed consent form (ICF). Willing to follow and able to complete all test procedures;
- Female, ≥18 years old and ≤70 years old at the time of signing the ICF;
- Patients with unilateral breast cancer diagnosed by histopathology or cytology;
- No distant metastasis;
- To undergo unilateral axillary sentinel lymph node biopsy or unilateral axillary lymph node dissection;
Key exclusion criteria (6 listed)
- Breast malignancy derived from other tumors rather than the primary breast cancer;
- Patients with second primary tumor;
- Contraindication to airwave compression therapy: Acute venous thrombosis; Acute inflammatory skin disease; Erysipelas; Arrhythmia; Pulmonary edema; Unstable hypertension; People with artificial pacemakers; Deep thrombophlebitis;
- Have a history of mental illness or other reasons can not cooperate with treatment;
- Embolism, cardiogenic edema, hepatogenic edema and the history of upper limb trauma and other related complications;
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 |
|---|---|---|
| airwave compression therapyAlso: Airwave pressure therapy，intermittent pneumatic compression pump，IPCAirwave compression therapy was given to patients after breast cancer surgery to treat the ipsilateral upper limb | Device | experimental group |
| standard care: health education and routine functional exercisestandard care: health education and routine functional exercise | Other | control group, experimental group |
Primary outcome
Incidence of lymphedema
Time frame: 18 months
Incidence of lymphedema of ipsilateral upper limb
2 secondary outcomes
Symptoms
Time frame: 18 months
Quality of life assessment
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing airwave compression therapy in people with Breast Cancer, run by Shantou Central Hospital 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 7 inclusion and 6 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 10 Jul 2024. 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 Zhi-Yong Wu, Dr. (008613502953050, stwzy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of lymphedema (time frame: 18 months). 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 10 Jul 2024.