NCT07374835|Enrolling By Invitation
BMI Stratified Management Based on Meridian-Lymph Axis Theory for Lower Extremity Lymphedema After Gynecologic Cancer Surgery
MLA-BMI-LLE
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MLA-BMI-LLE
Sponsor study identifier
interventional
60
1 country
1
Study Start
October 9, 2025
Actual (reported)Primary Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
This study aims to investigate the impact of a BMI-stratified intervention program based on the meridian-lymphatic axis theory on the incidence of lower extremity lymphedema in postoperative patients with gynecological malignant tumors at 1 month, 3 months, and 6 months, and to validate the precision and effectiveness of this program compared to traditional CDT. Primary objectives: to evaluate the effects of this program on reducing the incidence of lymphedema, alleviating lymphedema-related symptoms (assessed via GCLQ score), improving patients' quality of life (assessed via LLQoL score), and enhancing patients' self-management behaviors.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 9, 2025
Actual (reported)January 21, 2026
Actual (reported)January 29, 2026
Actual (reported)December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Change in Lower Extremity Lymphedema Volume (Measured by Circumferential Method)
Limb volume change will be calculated using circumferential measurements of the lower extremity (ankle, calf, thigh) to quantify the reduction in lymphedema severity after intervention.
Baseline (before intervention), 12 weeks after intervention initiation
Change in Lower Extremity Lymphedema Volume (measured by circumferential measurement) from baseline to 12 weeks after intervention
Limb volume change will be calculated using circumferential measurements of the lower extremity to assess the efficacy of the intervention in reducing lymphedema.
Baseline, 12 weeks
Change in Limb Function Score (using the Lymphoedema Functioning, Disability and Health Questionnaire, LYMPH-Q) from baseline to 12 weeks
baseline to 12 weeks
Change in Quality of Life Score (using the European Organization for Research and Treatment of Cancer QLQ-C30) from baseline to 12 weeks
baseline to 12 weeks
Participants receive personalized management based on BMI, combining meridian conditioning and lymphatic circulation interventions.
Participants receive standard lymphatic edema care (e.g., compression garments, basic exercise guidance).
Personalized interventions including meridian point stimulation, manual lymphatic drainage, and pressure care, stratified by participant BMI.
Standard care including compression garment use, limb elevation, and basic exercise guidance.
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
Geng Y, Zhang H. Effect of BMI-stratified management based on the meridian-lymph axis theory on lower extremity lymphedema after gynecological cancer surgery: a randomized controlled trial. Front Oncol. 2026 Sep 24;16:1900880. doi: 10.3389/fonc.2026.1900880. eCollection 2026.
First Submitted
January 21, 2026
First Posted
January 29, 2026
Study Start
October 9, 2025
Actual (reported)Primary Completion
December 31, 2026
EstimatedRegistry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
January 29, 2026
Record last verified: 2026-01
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Source: ClinicalTrials.gov.
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