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

Официальное название

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

Обзор

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.

Вмешательства

• Другое Meridian-Lymph Axis Based BMI Stratified Management
  Personalized interventions including meridian point stimulation, manual lymphatic drainage, and pressure care, stratified by participant BMI.
• Другое Routine Lymphatic Edema Care
  Standard care including compression garment use, limb elevation, and basic exercise guidance.

Первичные конечные точки

• Change in Lower Extremity Lymphedema Volume (Measured by Circumferential Method) [Срок оценки: 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 [Срок оценки: Baseline, 12 weeks]

Вторичные конечные точки (2)

• Change in Limb Function Score (using the Lymphoedema Functioning, Disability and Health Questionnaire, LYMPH-Q) from baseline to 12 weeks [Срок оценки: 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 [Срок оценки: baseline to 12 weeks]

Критерии участия

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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Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Ухань

Идентификаторы

NCT: NCT07374835 · TJ-IRB202512073

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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