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临床试验/NCT05793749
NCT05793749招募中不适用

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

Chongqing University Cancer Hospital1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2023年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
400
试验地点
1
主要终点
Incidence of lymphedema

研究概览

简要总结

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.

详细描述

Research background Gynecological malignancies, including cervical cancer, ovarian cancer, endometrial cancer, vulvar cancer, etc., are important diseases threatening women's health worldwide, and their main treatment methods are surgery and radiotherapy. During surgery, different numbers of lymph nodes are removed, and lymphatic fluid and tissue exudate from the stump lymphatic vessels accumulate, causing disruption of the original lymphatic circulation and obstruction of lymphatic fluid return, which leads to lower limb edema . The longer the radiotherapy lasts, the more serious the phenomenon of collateral circulation will be, and the lymphatic return pathway will be damaged, resulting in lower limb lymphedema .

Lower extremity lymphedema is a relatively common complication after treatment for gynecologic malignancies, and it has been reported that approximately 20 million patients worldwide are affected by lower extremity lymphedema. The overall incidence of lower extremity lymphedema after gynecologic malignancy treatment is about 25% and can be as high as 70% in special groups . Age, weight, radiotherapy dose, duration of postoperative radiotherapy, tumor stage, daily standing time, number of lymph node dissection, and co-infection are all risk factors for the occurrence of lower extremity lymphedema.

Lymphedema is characterized by sunken edema at the beginning of the disease and progresses to include swelling, numbness, heaviness, tissue fibrosis, impaired movement, and rough epidermal keratinization, and increases the risk of inflammation of the lymphatic vessels and surrounding tissues and cellulitis. Lower extremity lymphedema is a chronic progressive disease that is difficult to cure and has a negative impact on limb function, daily life, quality of life and psychological well-being.

The treatment of lymphedema includes surgical treatment and conservative treatment. The conservative treatment methods include Complex Decongestion Therapy (CDT), external application of Chinese herbal medicine and western medicine, etc. The Complex Decongestion Therapy (CDT) is the most widely used lymphedema treatment with the best efficacy internationally in recent years. The treatment method, but requires long-term or even lifelong care , which brings huge psychological burden and economic pressure to the patient's family. Therefore, lymphedema of the lower extremities should be prevented, and preventive and therapeutic measures should be taken as early as possible to improve the quality of life of patients.

Currently, studies on lymphedema prevention have focused on interventions for breast cancer-related lymphedema , while few studies have been reported on the prevention of lymphedema associated with gynecologic malignancies. Research reported that early intervention with freehand lymphatic drainage technique could effectively prevent lower limb lymphedema, and Research showed that full range of hip exercises could prevent lower limb lymphedema after cervical cancer surgery, in addition, some studies also found that freehand lymphatic drainage combined with Kegel training could prevent vulvar stage I lymphedema after cervical cancer surgery, however, these studies have some limitations, such as small sample size and limited study content. However, these studies have limitations, such as small sample size and limited study content. Moreover, there are no empirical studies on the prevention of lower extremity lymphedema in large samples, and there is no unified standard for the prevention and management of lower extremity lymphedema. Therefore, in this study, the investigators used an evidence-based approach and clinical experience to conduct a prospective study on the prevention of lower limb lymphedema in order to reduce the incidence of lower limb lymphedema, improve patients' quality of life, and reduce their economic burden.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •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
  • •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.

排除标准

  • •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;
  • •Recent major abdominal surgery (determined by the investigator);
  • •Radiation colitis, cystitis, intestinal infection, small bowel or large bowel diverticulitis or diverticulitis;
  • •Liver fibrosis;
  • •Abdominal aortic aneurysm;
  • •acute phlebitis;
  • •Severe arterial obstructive disease, arterial ulcer, ABPI (ankle-brachial blood pressure index) greater than 1.3 and less than 0.5;
  • •Severe peripheral neuropathy;
  • •Poor control of hypertension, poor control of stroke and diabetes, and severe bronchial asthma;
  • •Patients who cannot understand the experimental content and cannot cooperate and those who refuse to sign the informed consent;
  • •Those with concomitant diseases or other special circumstances that seriously endanger the patient's safety or affect the patient's completion of the study.

研究组 & 干预措施

Prophylactic lymphedema treatment

Experimental

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.

干预措施: Prophylactic lymphedema treatment (Behavioral)

Standard of care

No Intervention

Standard of care,includeIn knowledge education and telephone follow-up were routinely conducted.

结局指标

主要结局

Incidence of lymphedema

时间窗: Incidence of lymphedema in the prophylactic lymphedema treatment group and the standard treatment group at 2 years after the end of radiotherapy

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

Quality of life of patients

时间窗: 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

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.

次要结局

  • Subjective feelings(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-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)

研究者

发起方
Chongqing University Cancer Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dongling Zou

professor,Doctor

Chongqing University Cancer Hospital

研究点 (1)

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