BMI Stratified Management Based on Meridian-Lymph Axis Theory for Lower Extremity Lymphedema After Gynecologic Cancer Surgery (MLA-BMI-LLE)

BMI Stratified Management Based on Meridian-Lymph Axis Theory for Lower Extremity Lymphedema in Patients After Gynecologic Cancer Surgery

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Lower Extremity Lymphedema After Gynecologic Cancer Surgery
• Intervention / Treatment: Other: Meridian-Lymph Axis Based BMI Stratified Management; Other: Routine Lymphatic Edema Care

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:Female patients aged 18-75 years who have undergone gynecologic cancer surgery (including hysterectomy, oophorectomy, or lymphadenectomy).

Diagnosed with lower extremity lymphedema (stage I-II) within 6 months to 2 years post-surgery, confirmed by circumferential measurement.

BMI between 18.5 and 35.0 kg/m². Able to understand and sign the informed consent form, and comply with the intervention and follow-up schedule.

No history of severe cardiovascular, renal, or hepatic dysfunction that would interfere with study participation.

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Exclusion Criteria:Patients with lower extremity lymphedema caused by other etiologies (e.g., trauma, infection, or congenital lymphedema).

History of lower extremity surgery or fracture within 3 months prior to enrollment.

Active infection or skin ulceration in the affected lower extremity. Participation in other clinical trials involving lymphedema interventions within the past 3 months.

Pregnancy or lactation during the study period. Inability to complete the intervention or follow-up due to cognitive or mobility impairment.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BMI Stratified Management Group; Participants receive personalized management based on BMI, combining meridian conditioning and lymphatic circulation interventions.	Other: Meridian-Lymph Axis Based BMI Stratified Management; Personalized interventions including meridian point stimulation, manual lymphatic drainage, and pressure care, stratified by participant BMI.
Other: Routine Care Control Group; Participants receive standard lymphatic edema care (e.g., compression garments, basic exercise guidance).	Other: Routine Lymphatic Edema Care; Standard care including compression garment use, limb elevation, and basic exercise guidance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Hong Zhang

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: January 21, 2026
• First Submitted That Met QC Criteria: January 21, 2026
• First Posted (Actual): January 29, 2026

Study Record Updates

• Last Update Posted (Actual): January 29, 2026
• Last Update Submitted That Met QC Criteria: January 21, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Lower Extremity Lymphedema; Gynecologic Cancer Surgery; BMI Stratified Management; Meridian-Lymph Axis Theory
• Other Study ID Numbers: TJ-IRB202512073

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No