Status:
NOT_YET_RECRUITING
Complete Decongestive Therapy Versus Non-pneumatic Compression Therapy in Post Mastectomy Lymphedema
Lead Sponsor:
Lahore University of Biological and Applied Sciences
Collaborating Sponsors:
University of Lahore
Conditions:
Lymphedema, Breast Cancer
Mastectomy Related Lymphedema
Eligibility:
FEMALE
30-60 years
Phase:
NA
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 vol...
Detailed 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 l...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 26 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2027
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT07217288
Start Date
October 26 2025
End Date
April 30 2027
Last Update
October 15 2025
Active Locations (1)
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1
Cancer Care Hospital
Lahore, Punjab Province, Pakistan, 74600