BMI Stratified Management Based on Meridian-Lymph Axis Theory for Lower Extremity Lymphedema After Gynecologic Cancer Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Meridian-Lymph Axis Based BMI Stratified Management, Routine Lymphatic Edema Care.
- Who it may be relevant to
- Registry conditions: Lower Extremity Lymphedema After Gynecologic Cancer Surgery. Basic parameters: 18 years — 75 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
BMI Stratified Management Based on Meridian-Lymph Axis Theory for Lower Extremity Lymphedema in Patients After Gynecologic Cancer Surgery
Overview
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.
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 Lymphatic Edema Care
Standard care including compression garment use, limb elevation, and basic exercise guidance.
Primary outcome measures
- Change in Lower Extremity Lymphedema Volume (Measured by Circumferential Method) [Time frame: 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 [Time frame: Baseline, 12 weeks]
Secondary outcome measures (2)
- 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]
- 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]
Eligibility criteria
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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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan
Identifiers
NCT: NCT07374835 · TJ-IRB202512073