RecruitingNot ApplicableNCT05793749

Early Intervention to Prevent Lower Limb Lymphedema of Gynecological Malignancy

Early Intervention to Prevent Gynecological Malignant Tumors Clinical Study of Lymphedema of the Lower Limbs in Patients With Radiotherapy After Lymphadenectomy


Sponsor

Chongqing University Cancer Hospital

Enrollment

400 participants

Start Date

Apr 1, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an early intervention program to prevent leg swelling (lymphedema) in patients with gynecological cancers who are receiving radiation therapy after lymph node surgery. Lymphedema is a common and sometimes debilitating side effect. **You may be eligible if...** - You have a gynecological cancer and are undergoing radiation after lymph node removal - You are between 18 and 60 years old - You have a good performance status (able to carry out daily activities) - Your expected survival is more than 3 years - Your blood counts (hemoglobin, white blood cells, platelets) meet the required levels - You are willing to participate and have signed the consent form **You may NOT be eligible if...** - Your blood counts are below the required thresholds - You do not meet other health criteria your doctor will review Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALProphylactic 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.


Locations(1)

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

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NCT05793749


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