Lower Limb Lymphedema After Gyneco-oncologic Therapy: Can we Prevent Irreversible Lymphedema?
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 218
- 试验地点
- 4
- 主要终点
- Incidence rate of LLL
研究概览
简要总结
Trial developed to inventory the incidence of early and advanced stage lower limb lymphedema in patients diagnosed with and treated for gynaecologic cancer.
Four hundred patients with diagnosis stage 1-3 gynaecologic cancer will be included in an observational cohort between diagnosis until maximum 2 weeks after start of the first treatment. They will be followed for occurrence of lower limb lymphedema up till 2 years after their last treatment.
Data on signs and symptoms, quality of life, time investment and financial expenses will be collected, to provide information on the incidence and risk factors for lower limb lymphedema, and on its impact on patients, regarding quality of life, sexual well-being and time- and financial investment.
Patients developing early stage LLL enter an interventional sub-cohort, in which the effect of class II compressive garments on preventing evolution towards advanced stage LLL will be evaluated.
详细描述
Context of the problem: Improved knowledge on the diagnosis and treatment of cancer has resulted in an increased number of cancer survivors. Consequently, more patients are confronted, often life-long, with the complications of their cancer treatment. These chronic conditions impact daily functioning and quality of life (QoL), complicate the return to work and undermine psycho-social well-being. One of the most frequent and disabling complications is lymphedema, a condition undermining QoL to an extent exceeding even a 10-year age increase.
The damage of lymphedema covers many aspects of daily life: it changes body image and complicates daily activities as basic as clothing, it increases patient-related health expenditures for treatment and for coping with the disease, reduces patient autonomy in daily functioning and can even cause sensory or motor dysfunctions. So far, no definitive cure exists for lymphedema: patients are confined to life-long preventive measures, compression therapy and regular manual lymph drainage. Surgical repair may be an option in selected cases, but evidence on surgical techniques is limited and their long-term effects are still unknown. Moreover, even after successful repair, conservative treatment is still needed.
Most studies on lymphedema are limited to upper limb lymphedema (ULL), mainly after breast cancer treatment. Only a few publications focus on lower limb lymphedema (LLL), despite its detrimental impact on QoL. This could be due to the difficulties to diagnose and treat LLL in comparison to ULL: LLL often occurs bilaterally or at the level of the groins or genital region, hence impeding diagnosis through comparison. Perimetric measurement of large cone-like oedematous legs is cumbersome. Manual lymph drainage and application of compressive garments is more strenuous for legs than for arms, and the typical bilateral occurrence and large volumes of LLL inflate the cost of treatment garments. However limited, some groups did evaluate the incidence of LLL after pelvic treatment, but maintained the criteria for advanced stage lymphedema as cut off, thereby underestimating the prior phases in which patients are confronted with functional impairment due to LLL, without apparent swelling.
The observational cohort in this study is aimed at inventorying the incidence, timing and risk factors of early as well as advanced stage lymphedema. Time and cost-investment of patients for prevention and/or treatment of LLL will be analyzed. The impact of LLL on QoL and on sexual well-being will be calculated.
A sub-cohort of this trial is of interventional design: in patients, included in the observational cohort and developing early stage LLL, standard of care treatment will be started, including skin care, active exercises and manual lymph drainage. In the experimental group, compressive garments class II will be added and compliance as well as tolerance of these garments will be analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
No masking possible: the patient and the provider are well aware of yes or no wearing of compressive garments.
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent (ICF)
- •Female patient, recently diagnosed with gynaecologic cancer (cervix, endometrium, vulva, vagina, ovaries...) and candidate for curative treatment
- •Age ≥ 18 years
- •Understanding of the Dutch language
- •Able to understand the informed consent and willing to comply with the protocol, including use of diary or app and timely completion of requested questionnaires.
排除标准
- •History of treatment for gynaecologic cancer
- •Concurrent second primary tumor(s)
- •Pregnancy or pregnancy planned within 2 years
- •Known metastasized cancer at the time of inclusion (D0)
- •Severe injury, surgery or deformation of the legs or groins in the past
- •Vascular malformation of the leg or untreated venous insufficiency with oedema (CEAP C4 or more)
- •Mental or psychological problems, inability to comply to the study protocol
- •First treatment administered > 2 weeks before
- •Clinical signs and symptoms of lymphedema present (ISL stage 0 or higher) at the moment of intake
结局指标
主要结局
Incidence rate of LLL
时间窗: From diagnosis until 2 years after last oncologic treatment
Number of patients with transition (evolution) to stage 0-3 LLL (ISL criteria) in the first two years after treatment for gynecologic cancer. We defined three potential transitions: * T1: from no LLL to reversible stage 0-1 LLL * T2: from no LLL to irreversible stage 2-3 LLL * T3: from stage 0-1 LLL to stage 2-3 LLL
Incidence rate of transition from stage 0-1 LLL to stage 2-3 LLL in randomized subgroup
时间窗: From transition to stage 0-1 LLL until 1 year after
Number of patients diagnosed with stage 0-1 LLL within one year after treatment for gynecologic cancer and that evolve from stage 0-1 LLL to stage 2-3 LLL
次要结局
- Risk factors for developing LLL - smoking status(From diagnosis until 2 years after last oncologic treatment)
- Risk factors for developing LLL - weight(From diagnosis until 2 years after last oncologic treatment)
- Risk factors for developing LLL - per BMI category the number of patients that develop lower limb lymph-edema as assessed with ISL criteria (reported value)(From diagnosis until 2 years after last oncologic treatment)
- Risk factors for developing LLL - Marital status(From diagnosis until 2 years after last oncologic treatment)
- Risk factors for developing LLL - alcohol intake(From diagnosis until 2 years after last oncologic treatment)
- Risk factors for developing LLL - number of patients with contact allergy that develop lower limb lymph-edema as assessed with ISL criteria(From diagnosis until 2 years after last oncologic treatment)
- Risk factors for developing LLL - per age category the number of patients that develop lower limb lymph-edema as assessed with ISL criteria(From diagnosis until 2 years after last oncologic treatment)
- Timing of development of LLL(From diagnosis until 2 years after last oncologic treatment)
- Risk factors for developing LLL - height(From diagnosis until 2 years after last oncologic treatment)
- Risk factors for developing LLL - per category of physical activity the number of patients that develop lower limb lymph-edema as assessed with ISL criteria(From diagnosis until 2 years after last oncologic treatment)
- Risk factors for developing LLL - obstetrical status(From diagnosis until 2 years after last oncologic treatment)
- Risk factors for developing LLL - education status(From diagnosis until 2 years after last oncologic treatment)
- Risk factors for developing LLL - employment status(From diagnosis until 2 years after last oncologic treatment)
- Risk factors for developing LLL - pack-years(From diagnosis until 2 years after last oncologic treatment)
- Risk factors for developing LLL - pain score(From diagnosis until 2 years after last oncologic treatment)
- Risk factors for developing LLL - tumor stage (FIGO)(From diagnosis until 2 years after last oncologic treatment)
- Risk factors for developing LLL - physical appearance(From diagnosis until 2 years after last oncologic treatment)
- Risk factors for developing LLL - household income category(From diagnosis until 2 years after last oncologic treatment)
- Risk factors for developing LLL - number of patients with medical record of disease (renal, cardiac, diabetic...) that develop lower limb lymph-edema as assessed with ISL criteria(From diagnosis until 2 years after last oncologic treatment)
- Risk factors for developing LLL - tumor stage (TNM)(From diagnosis until 2 years after last oncologic treatment)
- Risk factors for developing LLL - the number of patients with limited (only one or two gynaecologic organs) or extensive surgery (multiple organs and/or lymph nodes) that develop lower limb lymph-edema as assessed with ISL criteria(From diagnosis until 2 years after last oncologic treatment)
- Risk factors for developing LLL - the number of patients receiving systemic therapy that develop lower limb lymph-edema as assessed with ISL criteria(From diagnosis until 2 years after last oncologic treatment)
- Risk factors for developing LLL - the number of patients receiving radiotherapy that develop lower limb lymph-edema as assessed with ISL criteria(From diagnosis until 2 years after last oncologic treatment)
- Impact of LLL on QoL - EQ5D(From diagnosis until 2 years after last oncologic treatment)
- Impact of LLL on QoL - EORT qlq C30(From diagnosis until 2 years after last oncologic treatment)
- Impact of LLL on sexuality(From diagnosis until 2 years after last oncologic treatment)
- Predictive value of the self-report LLL questionnaire(From diagnosis until 2 years after last oncologic treatment)
- Inventory of expenses(From diagnosis until 2 years after last oncologic treatment)
- Impact of LLL on QoL - lymph-ICF-LL(From diagnosis until 2 years after last oncologic treatment)
- Value of ICG fluoroscopy versus lymphoscintigraphy in detection of early stage LLL(From diagnosis until 2 years after last oncologic treatment)
- Inventory of time investment(From diagnosis until 2 years after last oncologic treatment)
- Standardization of perimetric measurements(From diagnosis until 2 years after last oncologic treatment)