Clinical trial · Interventional
Complete Decongestive Therapy Versus Non-pneumatic Compression Therapy in Post Mastectomy Lymphedema
Effectiveness of Complete Decongestive-versus Non-pneumattic- Compression Therapy in Patients With Post-mastectomy Lymphedema
NCT07217288CI-TRIAL-00096562CDTnot yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of the study is to compare the effectiveness of Complete Decongestive Therapy and Non-Pneumatic Compression Therapy, both combined with routine physical therapy, in reducing pain and edema volume, improving range of motion, respiratory function, inflammatory markers, and overall quality of life in patients with post-mastectomy lymphedema.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphedema, Breast Cancer | — | UNRESOLVED | — |
| Mastectomy Related Lymphedema | — | UNRESOLVED | — |
| Post Mastectomy Lymphedema | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Complete Decongestive therapy | Other | — | UNRESOLVED |
| Non Pneumatic compression device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Complete Decongestive Therapy (CDT) and Routine Physical Therapy
- description
- Group A: Complete Decongestive Therapy (CDT) and Routine Physical Therapy: Manual Lymphatic Drainage (MLD) * Duration: 30 minutes/session * Frequency: 5 days/week * Technique: Performed by a certified lymphedema therapist * Areas: Neck, axilla, trunk, and affected limb * Total treatment time: 8 weeks 2. Compression Bandaging * Type: Multi-layer short-stretch bandaging * Application: After MLD in each session * Worn Duration: 22-23 hours/day * Reapplied Daily: Yes 3. Skin Care * Duration: 10 minutes/session * Components: * Inspection of skin * Use of pH-neutral moisturizers * Infection prevention education 4. Exercise Therapy (Routine Physiotherapy) * Type: Gentle, active ROM and resistance exercises (e.g., shoulder mobility, grip strengthening) * Duration: 20 minutes/session * Progression: Gradually increase intensity over 8 weeks
- interventionNames
- Other: Complete Decongestive therapy
- type
- EXPERIMENTAL
- label
- Group B: Non-pneumatic compression device (NPCD) and Routine Physiotherapy (RPT)
- description
- Subjects will be taught how to apply the device themselves, including placement, duration of use, and turning it on/off. All subjects will be instructed to wear the device for up to 40 minutes per day and to continue their usual activity during use. Routine Physical Therapy: * Type: Gentle, active ROM and resistance exercises (e.g., shoulder mobility, grip strengthening) * Duration: 20 minutes/session * Progression: Gradually increase intensity over 8 weeks
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Females with age between 30 to 60 years. (Monticciolo et al., 2021) * Females with unilateral mastectomy post three months of surgery. (Shen et al., 2023) 21 * A volume difference to the circumferential measurements between the affected and unaffected upper extremities of more volume difference\>10%. * Completed chemotherapy and/or radiation therapy. (Borman, Yaman, Yasrebi, İnanlı, \& Dönmez, 2022) Exclusion Criteria: * Systemic disorders that might contraindicate the use of sequential compression therapy i.e. chronic kidney disease with renal failure, Congestive heart failure, neurological disorders, respiratory disorders. * Presence of active cellulitis, open and partially healed wounds. * Patients with lipedema * Active or recurrent cancer (defined as \< 3 months since completion of cancer therapy) * An acute infection within the previous 4 weeks * Active venous thromboembolic edema * Pregnant women and women who are planning or nursing at study entry. * Patients who had participated in any clinical trial of an investigational substance or device during the previous 30 days * Potential patients with a cognitive or physical impairment that would interfere with appropriate use of the device. (Rockson, Whitworth, et al., 2022)
References
Publications (0)
Data not yet available
No reference posted for this study.