Complete Decongestive Therapy Versus Non-pneumatic Compression Therapy in Post Mastectomy Lymphedema (CDT)

Lahore University of Biological and Applied Sciences

Status: Not yet enrolling

Conditions: Mastectomy Related Lymphedema; Lymphedema, Breast Cancer; Post Mastectomy Lymphedema

Treatments: Other: Complete Decongestive therapy; Device: Non Pneumatic compression device

Study type: Interventional

Funder types: Other

Identifiers

NCT07217288

UOL/IREB/25/12/0042

U1111-1329-7030 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

Post-mastectomy lymphedema (PML) is a chronic, progressive, and disabling complication affecting breast cancer survivors due to disruption of lymphatic drainage following surgery or radiotherapy. It leads to swelling, pain, restricted range of motion, recurrent infections, and reduced quality of life.

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.

Enrollment: 52 estimated patients

Sex: Female

Ages: 30 to 60 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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52 participants in 2 patient groups

Complete Decongestive Therapy (CDT) and Routine Physical Therapy

Active Comparator group

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

Treatment:

Other: Complete Decongestive therapy

Group B: Non-pneumatic compression device (NPCD) and Routine Physiotherapy (RPT)

Experimental group

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

Treatment:

Device: Non Pneumatic compression device