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Multi-center rater-blinded study of early intervention with the Hand Incubator for breast-cancer-related lymph edema

Multi-center rater-blinded study of early intervention with the Hand Incubator for breast-cancer-related lymph edema - BEAT-EDEMA trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000026124
Enrollment
24
Registered
2017-05-10
Start date
2017-04-01
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

breast cancer-related lymphedema

Interventions

Hand Incubator 4weeks Without Hand Incubator

Sponsors

Nagoya University
Lead Sponsor
Aichi Cancer Center
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients diagnosed with stage 0 or 1 breast cancer-related lymphedema by L-Dex (L-Dex index increase by 10 or more compared to before surgery) within 12 weeks after breast cancer surgery; condition of ECOG PS 0 or 1.

Exclusion criteria

Exclusion criteria: Patients undergoing surgery for bilateral breast cancer or with surgical history of the opposite breast; breast cancer stage4; patients who have trauma with deformation, degenerative diseases or inflammatory diseases in the upper extremities, now or in the past; conditions of double cancers, collagen diseases, rheumatoid arthritis, nephrosis, heart failure, insect bites, cellulitis or other edema; conditions of severe interruption in the circulation, congestive heart failure or phlegmasia cerulea dolens; patients with perceptual disorder or sensory disorder at the Hand Incubator attachment site; patients with inflammation, suppuration, painful skin diseases or wounds at the Hand Incubator attachment site; patients with hypersensitivity to vinyl chloride or polyurethane; patients with allergies to ICG, iodine or hydrogel; patients with implanted pacemaker; pregnant or lactating women; patients who are unable to obtain written informed consent; patients judged to be inappropriate for participation to this study.

Design outcomes

Primary

MeasureTime frame
Change in volume of affected upper limb

Secondary

MeasureTime frame
ICG evaluation, L-Dex index,the upper limb volume after using Hand Incubator

Countries

Japan

Contacts

Public ContactKatsuyuki Iwatsuki

Nagoya University Hand Surgery

kiwatsuki@med.nagoya-u.ac.jp052-744-2957

Outcome results

None listed

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