Health TrialsbyHealthPanel

Airwave Compression Therapy to Prevent Breast Cancer-related Lymphedema

ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorShantou Central Hospital

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • airwave compression therapy

    Device

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

  • standard care: health education and routine functional exercise

    Other intervention

    standard care: health education and routine functional exercise

Treatment groups

132 Participants
are divided into 2 treatment groups
Group A: control groupActive comparator 1 intervention
Group B: experimental groupExperimental treatment 2 interventions

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shantou Central Hospital

Lead sponsor

Source ClinicalTrials.gov
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