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Preventing early breast cancer-related arm lymphedema by compression sleeves after axillary lymph node dissection: a randomized controlled trial

Preventing early breast cancer-related arm lymphedema by compression sleeves after axillary lymph node dissection: a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200056273
Enrollment
Unknown
Registered
2022-02-03
Start date
2022-02-07
Completion date
Unknown
Last updated
2025-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer-related arm lymphedema

Interventions

Prophylactic compression sleeves group:The intervention group will wear medical compression sleeves for upper limbs with a pressure level of 2 (23-32mmHg) during the day for 12 months. The group will
Control group:The control group will proceed as an observation and receive standard lymphedema education during the clinical trial.

Sponsors

Fudan University Shanghai Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Female patients aged 18-70 years; 2. Clear consciousness, normal language expression, reading ability, and barrier-free communication with investigators; 3. Patients who can understand the contents of this study and obtain consent; 4. Patients undergoing axillary lymph node dissection; 5. Able to visit regularly for measurement.

Exclusion criteria

Exclusion criteria: 1. Persons with mental disorders, senile dementia, and cognitive impairments; 2. Severe heart failure, renal failure, liver disease, etc.; 3. Upper limb disability; edema symptoms such as cardiogenic, nephrogenic, and malnutrition; 4. Patients with bilateral breast cancer, recurrence, or metastasis to other organs.

Design outcomes

Primary

MeasureTime frame
To evaluate the incidence of breast cancer-related lymphedema (relative volume change >= 10%) [ Time Frame: Up to 12 months ];

Secondary

MeasureTime frame
To evaluate the incidence of breast cancer-related lymphedema (relative volume change >= 10%) [ Time Frame: Up to 24 months ];To Evaluate quality of life using Breast Cancer and Lymphedema Symptom Experience Index questionnaire [ Time Frame: Up to 24 months ];To evaluate the incidence of breast cancer-related lymphedema using tape measurement(The difference of 2 cm or more at any level compared with the opposite upper extremity) [ Time Frame: Up to 12 months ];Stage of the lymphedema [ Time Frame: Up to 24 months ];

Countries

China

Contacts

Public ContactZhiming Shao

Fudan University Shanghai Cancer Center

zhimingshao@outlook.com+86 139 1704 9952

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026