Early Intervention to Prevent Lower Limb Lymphedema of Gynecological Malignancy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-60
SponsorChongqing University Cancer Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Lymphedema and deep vein thrombosis of the lower extremities were clearly diagnosed;

Acute infection of any kind;

Patients with lower extremity edema;

pregnancy, menstrual period;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Prophylactic lymphedema treatmentExperimental treatment 1 intervention
Group B: Standard of careNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Incidence of lymphedema

The incidence of lower extremity lymphedema after gynecological cancer surgery and radiotherapy, and the incidence of lower extremity lymphedema after prophylactic lymphedema treatment.

Time frame
Incidence of lymphedema in the prophylactic lymphedema treatment group and the standard treatment group at 2 years after the end of radiotherapy
2

Quality of life of patients

The quality of life of cancer patients (QLQ-C30) was used to assess the quality of life of patients. Including the overall quality of life subscale, functional subscale, symptom subscale, and individual test items. The higher the overall quality of life subscale and the functional subscale score, the better the quality or function. The more severe the symptoms.

Time frame
Quality of life QLQ-C30 scores for the prophylactic lymphedema treatment group and the standard treatment group at 2 years after the end of radiotherapy

Secondary outcomes

1

Subjective feelings

The Gynecologic Cancer Lymphedema Questionnaire (GCLQ) was used to evaluate the subjective feelings of patients, which was mainly used to evaluate whether the limbs had symptoms such as swelling, pain, and heaviness. The evaluation included 7 symptom groups of heaviness, edema (overall), swelling (local), infection-related symptoms, pain, numbness, and limb function, with a total of 20 items.1 mark for "yes" and 0 mark for "no" for each entry. The higher the GCLQ score, the worse the subjective perception, and a score greater than or equal to 4 is recognized as the onset of lymphedema.

Time frame
Quality of life GCLQ scores for the prophylactic lymphedema treatment group and the standard treatment group at 2 years after the end of radiotherapy
2

2-year progression-free survival,2-year PFS

2-year PFS was defined as the time from randomization to the first occurrence of disease progression or death from any cause within 2 years

Time frame
2-year PFS was defined as the time from randomization to the first occurrence of disease progression or death from any cause within 2 years

Other outcomes

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