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

NCT07217288 | Not Yet Recruiting DMC FDA Device

• 2 other identifiers: UOL/IREB/25/12/0042U1111-1329-7030
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Outcome Measures

Primary Outcomes (1)

• Pain measured by visual analogue scale.

  Lymphedema-related symptoms (pain, pressure, heaviness and hardness). The visual analogue scale (VAS) is a validated, subjective measure for acute or chronic pain. Scores are based on self-reported measures of symptoms from 0-10 score. With zero "no pain" and 10 "worst pain". Test-rater reliability has been shown to be good, but higher among literate (r= 0.94, P=0.001) than illetrate patients (r= 0.71, P=0.001).

  Assessment will be done at baseline, 4th week and 8th week.

Secondary Outcomes (6)

• Edema volume by water displacement method

  Assessment will be done at baseline, 4th week and 8th week.

• Quality of life measured by Lymphoedema Functioning Disability and health questionnaire for the upper limb (Lymph-ICF-UL)

  Assessment will be done at baseline, 4th week and 8th week

• Functional mobility measured by upper extremity functional index

  Assessment will be done baseline, 4th week and 8th week

• Upper limb range of motion measured by goniometer

  Assessment will be done at baseline, after 4th week and 8th week

• Respiratory functions measured by spirometer

  Assessment will be done baseline, 4th week and 8th week

Study Arms (2)

Complete Decongestive Therapy (CDT) and Routine Physical Therapy

ACTIVE COMPARATOR

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

Other: Complete Decongestive therapy

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

EXPERIMENTAL

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

Device: Non Pneumatic compression device

Interventions

Non Pneumatic compression device 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.

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

Complete Decongestive therapy OTHER

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.

Complete Decongestive Therapy (CDT) and Routine Physical Therapy

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Lahore University of Biological and Applied Sciences: lead
• University of Lahore: collaborator

Study Sites (1)

Cancer Care Hospital

Lahore, Punjab Province, 74600, Pakistan

Location

MeSH Terms

Conditions

Breast Cancer Lymphedema

Condition Hierarchy (Ancestors)

Lymphedema; Lymphatic Diseases; Hemic and Lymphatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Sahar Fatima, Ph.D

CONTACT

+923371683000; fatima.sahar0212@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sahar Fatima

Study Record Dates

• First Submitted: October 9, 2025
• First Posted: October 15, 2025
• Study Start: October 26, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: October 15, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)