Breast Cancer Related Lymphedema Breast cancer related lymphedema, breast cancer, axillary lymph node dissection, radiation therapy, secondary lymphedema
Conditions
Interventions
application of a low- or high-pressure compression sleeve to the affected upper limb
D058128
prophylactic compression sleeve, graduated compressiono
Sponsors
Bando Hiroko
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: (1) Patients aged more than or equal to 18 and less than or equal to 75 years at the time of informed consent (2) Primary breast cancer, Stage I-IIIC (3) Patients who have underfone axillary lymph node dissection for primary breast cancer (4) ECOG Performance Status 0-1 (5) Able to provide written informed consent, understand the study procedures, and appropriately complete all patients questionnnaires (6) Capable of independently applying and properly wearing the compression sleeve
Exclusion criteria
Exclusion criteria: (1) Primary lymphedema (2) Any prior surgery or treatment to the ipsilateral upper limb or axilla that could impair lymphatic function before the current treatment (3) Skin trauma, infectious disease, or inflammatory skin disease of the ipsilateral upper limb (4) Peripheral arterial disease (5) Severe sensory or motor neuropathy of the ipsilateral upper limb (6) Severe congestive heart failure (7) Poorly controlled diabetes mellitus (8) Known allergy or hypersensitivity to materials used in the study compression sleeve (9) Arm size outside the available sleeve size range (10) Severe deformity of the ipsilaretal upper limb (11) Any other condition that, in the investigator's judgement, makes the patient unsuitable for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion developing upper-limb lymphedema by 12 months post-ALND | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Change from baseline in FACT-B + 4ARM (2) Change from baseline in QuickDASH score (3) Change from baseline in arm sircumference at predefined measument sites (4) Time from ALND to onset of upper-limb lymphedema (5) Compression-sleeve wear time based on patient diary (6) Performance of lymphedema-prevention self-care behaviours per patient diary (7) Frequency of prescribed exercise/rehabilitation per patient diary (8) Patient-reported symptoms attributable to sleeve wear assessed using PRO-CTCAE v1.0. (9) Adherence to compression therapy, defined as the proportion of days with more than 8 hours/day of wear (10) Incidence of adverse events related to postoperative upper-limb lymphedema, such as lymphorrhea, pain, and cellulitis (11) Patient satisfaction assessed by the end-of-study questionnaire (12) Continuation of compression-sleeve use after trial completion (13) Cumulative incidence of upper-limb lymphedema at 24 months after ALND | — |
Contacts
Public ContactAoi Hoshi
University of Tsukuba Hospital
Outcome results
None listed