Complete Decongestive Therapy Versus Non-pneumatic Compression Therapy in Post Mastectomy Lymphedema
NCT ID: NCT07217288
Last Updated: 2025-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
52 participants
INTERVENTIONAL
2025-10-26
2027-04-30
Brief Summary
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Detailed Description
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Complete Decongestive Therapy (CDT) - a multimodal approach involving manual lymphatic drainage, compression bandaging, skin care, and exercise - is currently the gold standard for lymphedema management. However, CDT is time-consuming, therapist-dependent, and often poorly tolerated or inaccessible for long-term self-management.
Non-Pneumatic Compression Therapy (NPCD) is a newer, portable, and wearable device that provides gradient sequential compression while allowing mobility and daily activity during treatment. It potentially improves adherence, comfort, and patient satisfaction.
Limited comparative research exists evaluating the relative effectiveness of CDT and NPCD in post-mastectomy lymphedema. This study aims to fill this gap and determine which approach produces superior clinical and functional outcomes.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Complete Decongestive Therapy (CDT) and Routine Physical Therapy
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
Complete Decongestive therapy
Complete Decongestive Therapy (CDT), is the gold-standard, non-invasive treatment for lymphedema. It combines manual lymphatic drainage (MLD), compression bandaging, exercise therapy, and skin care to reduce limb swelling and improve lymphatic flow.
Frequency: 5 sessions per week for 8 weeks. Intensity: Gentle manual drainage with multilayer compression Time: 60 minutes per session. Type: Therapist-guided manual and compression therapy followed by self-management.
CDT aims to decongest the limb, prevent fibrosis and infection, and enhance mobility and quality of life in post-mastectomy lymphedema patients.
Group B: Non-pneumatic compression device (NPCD) and Routine Physiotherapy (RPT)
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
Non Pneumatic compression device
Non-Pneumatic Compression Device (NPCD) is a wearable, portable system providing gradient sequential compression through shape-memory alloy actuators instead of air pressure. Frequency: 5 sessions per week for 8 weeks.
Intensity: Moderate, rhythmic static and dynamic compression applied distally to proximally, allowing safe lymphatic drainage.
Time: 40 minutes per session, once daily.
Interventions
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Non Pneumatic compression device
Non-Pneumatic Compression Device (NPCD) is a wearable, portable system providing gradient sequential compression through shape-memory alloy actuators instead of air pressure. Frequency: 5 sessions per week for 8 weeks.
Intensity: Moderate, rhythmic static and dynamic compression applied distally to proximally, allowing safe lymphatic drainage.
Time: 40 minutes per session, once daily.
Complete Decongestive therapy
Complete Decongestive Therapy (CDT), is the gold-standard, non-invasive treatment for lymphedema. It combines manual lymphatic drainage (MLD), compression bandaging, exercise therapy, and skin care to reduce limb swelling and improve lymphatic flow.
Frequency: 5 sessions per week for 8 weeks. Intensity: Gentle manual drainage with multilayer compression Time: 60 minutes per session. Type: Therapist-guided manual and compression therapy followed by self-management.
CDT aims to decongest the limb, prevent fibrosis and infection, and enhance mobility and quality of life in post-mastectomy lymphedema patients.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
30 Years
60 Years
FEMALE
No
Sponsors
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University of Lahore
OTHER
Lahore University of Biological and Applied Sciences
OTHER
Responsible Party
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Sahar Fatima
Sahar Fatima
Locations
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Cancer Care Hospital
Lahore, Punjab Province, Pakistan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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U1111-1329-7030
Identifier Type: REGISTRY
Identifier Source: secondary_id
UOL/IREB/25/12/0042
Identifier Type: -
Identifier Source: org_study_id
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