Alternative treatment of combined physical therapy for lymphedema

JRCT ID: jRCTs042210018

Registered date:12/05/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Postsurgical breast cancer-related lymphedema
• Date of first enrollment: 20/04/2022
• Target sample size: 40
• Study type: Interventional
• Intervention(s): 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 groups have a wash out period for 2 weeks. The subsequent month, each group undergo another therapy (Group H: combined physiotherapy, Group P: Hand incubator). After that, one month will be the follow-up observation period.

Outcome(s)

• Primary Outcome: The change in the volume of the affected upper limb after the treatment
• Secondary Outcome: Upper limb function (Hand 20 score), bioimpedance spectroscopy device (L-Dex index)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Saeki Sota
• Source(s) of Monetary Support: Nippon Sigmax Co., Ltd.