Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
FEMALE
NCT05793749

Early Intervention to Prevent Lower Limb Lymphedema of Gynecological Malignancy

Led by Chongqing University Cancer Hospital · Updated on 2023-03-31

400

Participants Needed

1

Research Sites

173 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Early Intervention to Prevent Lower Limb Lymphedema of Gynecological Malignancy

Who Can Participate

Age: 18Years - 60Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

1.Gynecologic oncology patients undergoing radiotherapy after lymph node surgery who voluntarily participate in this study and sign an informed consent form.

2.18 to 60 years old. 3.Eastern Cooperative Oncology Group(ECOG) score less than 2. 4.Expected survival time greater than 3 years. 5.Hemoglobin(Hb) greater than or equal to 70 g/L, white blood cells (WBC)greater than or equal to 3.5 × 109 /L, neutrophils(ANC)greater than or equal to 1.5 × 109 /L, platelets (PLT)greater than or equal to 80 × 109 /L.

6.serum alamine aminotransferase(ALT) and glutamic oxalacetic transaminase(AST) less than 2 times the normal value and creatinine less than 1.5 times the normal value, albumin greater than or equal to 35g/L.

7.Women of childbearing potential must have had a pregnancy test (serum or urine) within 7 days prior to enrollment and have a negative result and be willing to use an appropriate method of contraception for the duration of the trial.

8.Ability to comply with the trial protocol, as judged by the investigator.

Not Eligible

You will not qualify if you...

  1. Lymphedema and deep vein thrombosis of the lower extremities were clearly diagnosed;
  2. Acute infection of any kind;
  3. Patients with lower extremity edema;
  4. pregnancy, menstrual period;
  5. Recent major abdominal surgery (determined by the investigator);
  6. Radiation colitis, cystitis, intestinal infection, small bowel or large bowel diverticulitis or diverticulitis;
  7. Liver fibrosis;
  8. Abdominal aortic aneurysm;
  9. acute phlebitis;
  10. Severe arterial obstructive disease, arterial ulcer, ABPI (ankle-brachial blood pressure index) greater than 1.3 and less than 0.5;
  11. Severe peripheral neuropathy;
  12. Poor control of hypertension, poor control of stroke and diabetes, and severe bronchial asthma;
  13. Patients who cannot understand the experimental content and cannot cooperate and those who refuse to sign the informed consent;
  14. Those with concomitant diseases or other special circumstances that seriously endanger the patient's safety or affect the patient's completion of the study.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China, 400030

Actively Recruiting

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Research Team

D

Dongling Zou, Doctor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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