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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMI Stratified Management Group | Experimental | Participants receive personalized management based on BMI, combining meridian conditioning and lymphatic circulation interventions. |
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| Routine Care Control Group | Other | Participants receive standard lymphatic edema care (e.g., compression garments, basic exercise guidance). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meridian-Lymph Axis Based BMI Stratified Management | Other | Personalized interventions including meridian point stimulation, manual lymphatic drainage, and pressure care, stratified by participant BMI. |
| 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 |
| Measure | Description | 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 |
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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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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | 430030 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 17, 2025 | Jan 20, 2026 |
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| Routine Lymphatic Edema Care | Other | Standard care including compression garment use, limb elevation, and basic exercise guidance. |
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| baseline to 12 weeks |
| SAP_000.pdf |