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Enrolling by Invitation

NCT Number: NCT07374835

BMI Stratified Management Based on Meridian-Lymph Axis Theory for Lower Extremity Lymphedema 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.

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Key information

Conditions

Lower Extremity Lymphedema After Gynecologic Cancer Surgery

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

Meridian-Lymph Axis Based BMI Stratified Management

Other

Personalized interventions including meridian point stimulation, manual lymphatic drainage, and pressure care, stratified by participant BMI.

Routine Lymphatic Edema Care

Other

Standard care including compression garment use, limb elevation, and basic exercise guidance.

Primary outcomes

  1. Change in Lower Extremity Lymphedema Volume (Measured by Circumferential Method)

    Time frame: Baseline (before intervention), 12 weeks after intervention initiation

    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.

  2. Change in Lower Extremity Lymphedema Volume (measured by circumferential measurement) from baseline to 12 weeks after intervention

    Time frame: Baseline, 12 weeks

    Limb volume change will be calculated using circumferential measurements of the lower extremity to assess the efficacy of the intervention in reducing lymphedema.

Secondary outcomes

  1. Change in Limb Function Score (using the Lymphoedema Functioning, Disability and Health Questionnaire, LYMPH-Q) from baseline to 12 weeks

    Time frame: baseline to 12 weeks

  2. Change in Quality of Life Score (using the European Organization for Research and Treatment of Cancer QLQ-C30) from baseline to 12 weeks

    Time frame: baseline to 12 weeks

Sponsors and collaborators

Lead sponsor

Hong Zhang

Other

Registry information

Official study title

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

Acronym: MLA-BMI-LLE

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 29, 2026
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.