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NCT Number: NCT06495034

Airwave Compression Therapy to Prevent Breast Cancer-related 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).

Recruiting

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Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Shantou Central Hospital

Shantou, Guangdong, 510000, China

Location status: Recruiting

Location contact

Wan-Lin Zhan, Dr.

CONTACT

[email protected]

008619830233390

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

airwave compression therapy

Device

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

Other names: Airwave pressure therapy,intermittent pneumatic compression pump,IPC

standard care: health education and routine functional exercise

Other

standard care: health education and routine functional exercise

Primary outcomes

  1. Incidence of lymphedema

    Time frame: 18 months

    Incidence of lymphedema of ipsilateral upper limb

Secondary outcomes

  1. Symptoms

    Time frame: 18 months

    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.

  2. Quality of life assessment

    Time frame: 18 months

    FACT-B (V4.0)

Study contacts

Contact information is provided by the study sponsor or research team.

Zhi-Yong Wu, Dr.

CONTACT

[email protected]

008613502953050

Sponsors and collaborators

Lead sponsor

Shantou Central Hospital

Other

Registry information

Official study title

A Randomized Controlled Study on Early Intervention of Airwave Compression Therapy to Prevent Breast Cancer-related Upper Limb Lymphedema

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jul 10, 2024
Registry last updated
Jul 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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