Early Intervention to Prevent Lower Limb Lymphedema of Gynecological Malignancy

Sponsor
Chongqing University Cancer Hospital
Study ID
NCT05793749
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Prophylactic lymphedema treatment — BEHAVIORAL
    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.

Study Details

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.

Key Dates

First listed
Mar 31, 2023
Start date
Apr 1, 2023
Status verified
Mar 2023
Primary completion
Jul 29, 2026
Completion
Jul 29, 2026

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Prophylactic lymphedema treatment
    Prophylactic lymphedema treatment：The lymphedema prophylaxis treatment consists of four parts:manual lymphatic drainage, skin care, functional exercise, and wearing lymphedema preventive compression stockings. The prophylactic lymphedema treatment group receives lymphedema prophylaxis twice a week for a total of 10 sessions, each requiring an interval of at least 48 hours but no more than 2 weeks.
  • No Intervention: Standard of care
    Standard of care，includeIn knowledge education and telephone follow-up were routinely conducted.

Primary Outcome Measure

Incidence of lymphedema [ Time Frame: Incidence of lymphedema in the prophylactic lymphedema treatment group and the standard treatment group at 2 years after the end of radiotherapy ]

Central Contacts

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