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

Hong Zhang

Status: Invitation-only

Conditions: Lower Extremity Lymphedema After Gynecologic Cancer Surgery

Treatments: Other: Routine Lymphatic Edema Care; Other: Meridian-Lymph Axis Based BMI Stratified Management

Study type: Interventional

Funder types: Other

Identifiers

NCT07374835

TJ-IRB202512073

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

-

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.

-

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 2 patient groups

BMI Stratified Management Group

Experimental group

Description:

Participants receive personalized management based on BMI, combining meridian conditioning and lymphatic circulation interventions.

Treatment:

Other: Meridian-Lymph Axis Based BMI Stratified Management

Routine Care Control Group

Other group

Description:

Participants receive standard lymphatic edema care (e.g., compression garments, basic exercise guidance).

Treatment:

Other: Routine Lymphatic Edema Care