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Alternative treatment of combined physical therapy for lymphedema

Study of alternative treatment of combined physical therapy for postoperative lymphedema

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs042210018
Enrollment
40
Registered
2021-05-12
Start date
2022-04-20
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Postsurgical breast cancer-related lymphedema Breast cancer: Lymphedema

Interventions

The participants will be randomized 1:1 into the 2 groups. Initially wash out for 2 weeks. One group (Group H) use Hand incubator for a month, the other (Group P) undergo combined physiotherapy. Both

Sponsors

Saeki Sota
Lead Sponsor

Eligibility

Sex/Gender
All

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

MeasureTime frame
The change in the volume of the affected upper limb after the treatment

Secondary

MeasureTime frame
Upper limb function (Hand 20 score), bioimpedance spectroscopy device (L-Dex index)

Contacts

Public ContactChisato Osumi

Nagoya University Graduate School of Medicine

hand.secretary@med.nagoya-u.ac.jp+81-52-744-2957

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026