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Comparison of The Effectiveness of Commercial Pressure Garment and Simplified Multi-Layer Bandaging in Volume Reduction of Breast Cancer-related lymphedema patients

Comparison of The Effectiveness of Commercial Pressure Garment and Simplified Multi-Layer Bandaging in Volume Reduction of Breast Cancer-related lymphedema patients

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260210013
Enrollment
36
Registered
2026-02-10
Start date
2025-06-23
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Breast cancer-related Lymphedema Lymphedema Breast cancer Breast cancer-related Lymphedema Lymphedema Breast cancer Simplified multi-layer bandaging Compression bandage Compression garment Volume reduction Quality of life

Interventions

The simplified multi-layer bandaging consisted of two layers. The first layer comprised inelastic bandages applied directly to the limb, followed by a second layer of elastic bandages applied with app
Active Comparator Device,Active Comparator Device
Simplified multi-layer bandaging(SM),Pressure garment(PG)

Sponsors

Chulabhorn Royal Academy
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Female patients diagnosed with Breast cancer stage IB-IIIC who have completed primary cancer treatment 2.Presence of bilateral upper limb Lymphedema classified as stage I-II according to the International Society of Lymphology criteria 3.Aged >= 20 years 4.Circumference of the affected upper limb >= 2 cm greater than the contralateral limb at any measures level 5.Onset of Lymphedema occurring >= 6 months following Breast cancer surgery or radiation 6.No history of previous Lymphedema treatment

Exclusion criteria

Exclusion criteria: 1.Patients who have undergone bilateral axillary lymph node dissection 2.Patients who present with active skin inflammation of the affected upper limb(i.e. Cellulitis or Erysipelas) 3.Patients with metastatic Breast cancer or recurrent disease 4.Patients who are unable to read or comprehend the Thai language 5.Patients receiving medications known to cause or exacerbate edema 6.Patients who attend less than 75% of the prescribed treatment sessions(I.e./ fewer than 10 sessions)

Design outcomes

Primary

MeasureTime frame
Percentage of excessive volume(PEV) baseline, end of 1 week, end of 2 week, end of 3 week tape measurement

Secondary

MeasureTime frame
Heaviness score, tension score, and pain score baseline, end of 1 week, end of 2 week, end of 3 week 10-cm Visual Analog Scale(VAS),Disabilities of the ARM, Shoulder and Hand baseline, end of 1 week, end of 2 week, end of 3 week Disabilities of the ARM, Shoulder and Hand(DASH) Questionnaire,Quality of life baseline, end of 1 week, end of 2 week, end of 3 week FACT-B+4,Patient satisfaction with the treatment End of 3 week Global rating of Experience score(GRE)

Countries

Thailand

Contacts

Public ContactKittaphon Sawatthuk

Chulabbhorn Hospital

Kittaphon.saw@cra.ac.th025766000

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026