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Early Intervention to Prevent Lower Limb Lymphedema of Gynecological Malignancy

NCT05793749 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2023-03-31

No results posted yet for this study

Summary

This study is a prospective, randomized, controlled clinical trial of a single center in China and plans to enroll 400 patients.

1. Patients with diagnosed gynecological malignancies who underwent pelvic and abdominal lymphadenectomy and required pelvic radiotherapy;
2. Random grouping (A:B=3:1): A. Prophylactic lymphoedema treatment; B. Standard care group;
3. Preventive lymphedema health education was given to patients with gynecological malignant tumors without contraindications before surgery. All patients were randomly divided into an intervention group and a nonintervention group. The intervention group received preventive lymphedema treatment twice a week. 10 times, and the interval between the two treatments was not less than 48 hours and not more than 2 weeks. The intervention measures included four parts: manual lymphatic drainage, skin care, functional exercise, and wearing lymphedema preventive compression stockings. In the nonintervention group, knowledge education and telephone follow-up were routinely conducted.
4. All patients were evaluated for edema, lymphedema symptoms and quality of life 1 day before radiotherapy, every Friday during radiotherapy and every 3 months thereafter. Bioelectrical impedance measurement and leg diameter measurement were used to evaluate edema, the Gynecologic Cancer Lymphedema Questionnaire (GCLQ) was used to evaluate lymphedema symptoms, and the EORTC Quality of Life Scale (QLQ-C30) was used to evaluate quality of life. followed up to 2 years after the end of lymphedema prophylaxis.

Conditions

  • Uterine Cervical Neoplasms
  • Endometrial Neoplasms
  • Lymphedema
  • Treatment Effectiveness

Interventions

BEHAVIORAL

Prophylactic lymphedema treatment

1\. perform manual lymphatic drainage twice a week after the start of radiotherapy for a total of 10 times, and wear lymphedema compression stockings after each manual lymphatic drainage, 2. teach patients how to care for their skin. 3. perform functional exercises for lymphedema of the lower extremities twice a day for 15 \~ 20 minutes each time. 4. follow up observation: before the start of radiotherapy, every Friday during radiotherapy, and every 3 months after the end of radiotherapy, the occurrence of lymphedema and related symptoms and quality of life were evaluated.

Sponsors & Collaborators

  • Chongqing University Cancer Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-01
Primary Completion
2026-07-29
Completion
2026-07-29

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05793749 on ClinicalTrials.gov