BMI Stratified Management Based on Meridian-Lymph Axis Theory for Lower Extremity Lymphedema in Patients After Gynecologic Cancer Surgery
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Lower Extremity Lymphedema Volume (Measured by Circumferential Method)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
BMI Stratified Management Group
Participants receive personalized management based on BMI, combining meridian conditioning and lymphatic circulation interventions.
干预措施: Meridian-Lymph Axis Based BMI Stratified Management (Other)
Routine Care Control Group
Participants receive standard lymphatic edema care (e.g., compression garments, basic exercise guidance).
干预措施: Routine Lymphatic Edema Care (Other)
结局指标
主要结局
Change in Lower Extremity Lymphedema Volume (Measured by Circumferential Method)
时间窗: 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.
Change in Lower Extremity Lymphedema Volume (measured by circumferential measurement) from baseline to 12 weeks after intervention
时间窗: 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.
次要结局
- 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)
研究者
Hong Zhang
Associate Chief Nurse
Tongji Hospital