Complete Decongestive Therapy Versus Non-pneumatic Compression Therapy in Post Mastectomy Lymphedema (NCT07217288) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Complete Decongestive Therapy Versus Non-pneumatic Compression Therapy in Post Mastectomy Lymphedema
Pakistan52 participantsStarted 2025-10-26
Plain-language 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.
Who can participate
Age range30 Years – 60 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
What they're measuring
1
Pain measured by visual analogue scale.
Timeframe: Assessment will be done at baseline, 4th week and 8th week.
Trial details
NCT IDNCT07217288
SponsorLahore University of Biological and Applied Sciences