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RecruitingNCT06495034Updated Jul 10, 2024

Airwave Compression Therapy to Prevent Breast Cancer-related Lymphedema

An interventional study of airwave compression therapy and standard care: health education and routine functional exercise in Breast Cancer, sponsored by Shantou Central Hospital. Recruiting at 1 site in China. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-07-10.

Sponsored by Shantou Central Hospital · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 3 months ago, but the record still lists the study as recruiting.
  • Registered 1 year after the study started (first participant enrolled Jul 2023, registered Jul 2024).
  • Started Jul 2023; still recruiting 3 years 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
132
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
Female
01

Study 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 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.

02

Conditions studied

  • Breast Cancer

Keywords

  • breast cancer-related lymphedema
  • airwave compression therapy
  • quality of life
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 132 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Shantou Central Hospital is the lead sponsor of 3 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
132 participants (estimated)

Study arms

  • Active comparator
    control group

    standard care: health education and routine functional exercise

    Other: standard care: health education and routine functional exercise

  • Experimental
    experimental group

    1. standard care: health education and routine functional exercise; 2. airwave compression therapy

    Device: airwave compression therapy · Other: standard care: health education and routine functional exercise

Interventions

  • Deviceairwave compression therapy

    Airwave compression therapy was given to patients after breast cancer surgery to treat the ipsilateral upper limb

    Also known as: Airwave pressure therapy,intermittent pneumatic compression pump,IPC

  • Otherstandard care: health education and routine functional exercise

    standard care: health education and routine functional exercise

06

What researchers measure

Primary outcomes

  1. Incidence of lymphedema

    Incidence of lymphedema of ipsilateral upper limb

    Time frame: 18 months

Secondary outcomes

  1. 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.

    Time frame: 18 months

  2. Quality of life assessment

    FACT-B (V4.0)

    Time frame: 18 months

07

Study locations

1 of 1 sites recruiting
  • Shantou Central Hospital
    Shantou, Guangdong 510000, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06495034
Lead sponsor
Shantou Central Hospital
Responsible party
Si-Qi Qiu (Principal Investigator, Shantou Central Hospital) — Principal investigator
First posted
Jul 10, 2024
Start date
Jul 1, 2023
Primary completion
Jun 30, 2025 (estimated)
Completion
Jun 30, 2026 (estimated)
Last update
Jul 10, 2024

Study contacts

Zhi-Yong Wu, Dr.
Contact
stwzy@163.com
008613502953050

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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