Postsurgical breast cancer-related lymphedema Breast cancer: Lymphedema
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Postsurgical breast cancer-related lymphedema: Stage 1 or 2 of the modified international society of lymphology clinical staging of lymphedema Age of over 20 years Eastern Cooperative Oncology Group Performance Status of 0-1 Ability to understand how to use the Hand Incubator and L-Dex Ability to keep an accurate diary, and providing written informed consent after receiving a sufficient explanation regarding the study's purpose, protocol, and expected risks
Exclusion criteria
Exclusion criteria: 1.Bilateral breast cancer or who have undergone surgery at the opposite breast 2.Lymphvenous anastomosis performed within the past 6 month 3.Current or previous upper extremity trauma with deformation, degenerative disease, or inflammatory disease 4.Two or more concurrent diseases (cancers, collagen diseases, rheumatoid arthritis, nephrosis, heart failure, insect bites, cellulitis, or other edema) 5.Severely impaired circulation, congestive heart failure, or phlegmasia cerulea dolens 6.Perceptual or sensory disorders at the Hand Incubator attachment site 7.Inflammation, suppuration, painful skin diseases, or wounds at the Hand Incubator attachment site 8.Hypersensitivity to vinyl chloride or polyurethane 9.Allergies to ICG, iodine or hydrogel; an implanted pacemaker 10.Pregnancy or lactation 11.The absence of written informed consent 12.Judged to be inappropriate for the study by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in the volume of the affected upper limb after the treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Upper limb function (Hand 20 score), bioimpedance spectroscopy device (L-Dex index) | — |
Contacts
Nagoya University Graduate School of Medicine