Efficacy of Complete Decongestive Therapy for Limb Lymphedema: Response Profile and Predictive Modeling

Study acronym: LYMPH-PROG
StatusCompleted
PhaseNot specified
Started

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Record History

  1. Study First Submitted
Background: Complete decongestive therapy (CDT) is the standard treatment for lymphedema, but response varies by localization and laterality. Data on segmental distribution of therapeutic response and predictors of response are limited. Objective: To evaluate changes in lymphedema indicators after intensive-phase CDT, compare therapeutic response profiles across clinical subgroups, and develop a predictive model of response. Methods: Retrospective observational cohort study of 111 patients with secondary lymphedema: unilateral upper extremity, unilateral lower extremity, bilateral lower extremity. Primary outcome: percentage reduction of excess indicator (PREI) for unilateral groups and relative reduction of sum of circumferences (ΣC) for bilateral group. Secondary outcomes: topographic response profile (7 anatomical points), proportion of clinical responders (≥10%), predictive factors, and predictive model. Expected results: Identification of topographic heterogeneity of response, determination of factors of CDT resistance (especially in bilateral lymphedema), development of a validated predictive model for therapy personalization.
Trial Details
NCT Number NCT07878598
Lead Sponsor Ryazan State Medical University
Conditions
(from sponsor)		 Lymphedema, Secondary Lymphedema, Breast Cancer-Related Lymphedema, Upper Extremity Lymphedema, Lower Extremity Lymphedema After Gynecologic Cancer Surgery
Related terms Breast Cancer Lymphedema, Lymphedema
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov