The Enigma of Subjective Lymphedema: Who and Why do Patients Report Lymphedema After Breast Cancer Treatment Without an Objective Measurable Swelling? The Role of Lymphatic and Sensory Processing Problems
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 230
- 试验地点
- 2
- 主要终点
- Presence of subjective arm lymphedema
研究概览
简要总结
Breast cancer related lymphedema (BCRL) at the arm and/or trunk is an extremely dreaded complication after breast cancer treatment due to its chronicity and impact.
The incidence of objective arm and trunk/ breast BCRL is declining due to the major shift into the treatment approach of breast cancer. However, many patients report a sensation of swelling without the presence of objective BCRL, referred to as subjective BCRL. Therefore, subjective BCRL is defined as the diagnosis of BCRL based on the patient's sensation of a difference in size at the arm and/or trunk without the presence of objective BCRL.
At this moment, there is no clear information on the prevalence and the transitions between different BCRL states (no-subjective-objective) over time, as well as about the underlying mechanisms and contributing factors of subjective BCRL. Therefore, the investigators hypothesize that four mechanisms might be associated with the presence and severity of subjective arm or trunk/breast BCRL, including the presence and/ or severity of lymphatic (1) and sensory processing problems (nociceptive (2), neuropathic (3), and/or central sensory processing problems (4)).
The investigators will set up a prospective longitudinal study with breast cancer patients to determine the prevalence of subjective and objective arm or trunk/ breast BCRL at 1, 6, and 12 month(s) post-surgery and the transitions between different BCRL states (no-subjective-objective BCRL) (AIM 1). In addition, factors related to four potential underlying mechanisms (lymphatic, nociceptive, neuropathic, and central sensory processing problems) that contribute to the occurrence of subjective BCRL in comparison to no self-reported swelling and objective BCRL will be determined (AIM 2). Furthermore, the present study will be undertaken to determine factors related to these four underlying mechanisms that contribute to the severity of subjective BCRL at arm or trunk/ breast BCRL within the group of patients with subjective BCRL at different time-points after surgery (at 1, 6, and 12 month(s) post-surgery) (AIM 3).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •distant metastases
- •planned bilateral lymph node surgery
- •oedema of the arm from another cause
- •an allergy to iodine or Indocyanine Green (ICG), or
- •physically or mentally unable to participate throughout the entire duration of the study
结局指标
主要结局
Presence of subjective arm lymphedema
时间窗: Time frame up to 12 months post-surgery
The presence of subjective arm lymphedema will be determined by the combination of two items. If self-reported swelling at arm is "yes" and objective arm BCRL is "no", then the presence of subjective arm BCRL will be defined as yes. To determine the presence of self-reported swelling at arm, we will use the Norman Questionnaire. If the patient responds ''yes'' to the item self-reported difference in the sizes of at least one of 3 sites (hand, lower arm, and upper arm), the presence of 'self-reported swelling at arm' is recorded as ''yes''. To determine the presence of objective lymphedema at arm, please see outcome 3. Unit of the outcome measure is yes/no. Assessment at pre-surgery (baseline) and 1 month, 6 months, and 12 months post-surgery
Presence of subjective trunk/ breast lymphedema
时间窗: Time frame up to 12 months post-surgery
The presence of subjective trunk/ breast lymphedema will be determined by the combination of two items. If self-reported swelling at trunk/ breast is "yes" and objective trunk/ breast BCRL is "no", then the presence of subjective trunk/ breast BCRL will be defined as yes. To determine the presence of self-reported swelling at trunk/ breast, we will use the Norman Questionnaire. If the response is ''yes'' to the item self-reported difference in the sizes of at least one of these 2 sites (trunk or breast region), the presence of ''self-reported swelling in the trunk/breast'' is recorded as ''yes.'' Unit of the outcome measure is yes/no. Assessment at pre-surgery (baseline) and 1 month, 6 months, and 12 months post-surgery
Presence of objective arm lymphedema
时间窗: Time frame up to 12 months post-surgery
4 methods are used to determine the presence of objective arm lymphedema: a) relative hand volume difference, b) relative arm volume difference, c) bioimpedance analysis, and d) bioimpedance spectroscopy at arm region If at least one of four cut-off values is present, the presence of objective arm lymphedema will be considered as yes: 1. an increase of relative hand volume difference between the affected and non-affected hands of ≥5% compared to the baseline difference OR 2. an increase of relative arm volume difference between the affected and non-affected arms of ≥5% compared to the baseline difference OR 3. Extra-cellular water ratio by Bioimpedance Analysis at affected arm of \>0.3850 OR 4. Extracellular water ratio by Bioimpedance Spectroscopy, \>6.5 change in the L-Dex score from the baseline score Unit of the outcome measure is yes/no. Assessment at pre-surgery (baseline) and 1 month, 6 months, and 12 months post-surgery
Presence of objective trunk/ breast lymphedema
时间窗: Time frame up to 12 months post-surgery
2 methods are used to determine the presence of objective trunk/breast lymphedema: a) tissue dielectric measurement, b) skin thickness measurement at trunk/breast region If one of four criteria is present, the presence of objective trunk/ breast lymphedema will be considered as yes: 1. percentage of water content ratio at the trunk ≥ 1.32 OR 2. percentage of water content ratio at the trunk ≥ 1.40 OR 3. \> 2 standard deviations (SD) from the average skin thickness in at least one reference point on the trunk compared to the reference value at pre-surgery OR 4. \> 2 SD from the average skin thickness in at least one reference point one quadrant of the affected breast compared to the reference value at pre-surgery Unit of the outcome measure is yes/no. Assessment at pre-surgery (baseline) and 1 month, 6 months, and 12 months post-surgery
次要结局
- Amount of swelling at upper limb and trunk/breast(Time frame up to 12 months post-surgery)
- Severity of dermal rerouting at upper limb and trunk/breast(Time frame up to 12 months post-surgery)
- Severity of myofascial adhesions at the level of the scars(Time frame up to 12 months post-surgery)
- Severity of local muscle stiffness(Time frame up to 12 months post-surgery)
- Severity of local muscle tenderness(Time frame up to 12 months post-surgery)
- Severity of impaired shoulder range of motion(Time frame up to 12 months post-surgery)
- Presence of neuropathic pain at upper arm and trunk(Time frame up to 12 months post-surgery)
- Severity of sensory loss at the arm and trunk(Time frame up to 12 months post-surgery)
- Severity of altered cold sensation sensitivity at the arm and trunk(Time frame up to 12 months post-surgery)
- Severity of altered heat sensation sensitivity at the arm and trunk(Time frame up to 12 months post-surgery)
- Severity of altered sensory acuity in the arm and trunk(Time frame up to 12 months post-surgery)
- Severity of widespread hyperalgesia(Time frame up to 12 months post-surgery)
- Efficacy of inhibitory pain mechanism(Time frame up to 12 months post-surgery)
- Degree of pain facilitation(Time frame up to 12 months post-surgery)
- Severity of altered body perception(Time frame up to 12 months post-surgery)
- Severity of subjective arm lymphedema(Time frame up to 12 months post-surgery)
- Severity of subjective trunk lymphedema(Time frame up to 12 months post-surgery)
研究者
Nele Devoogdt
Prof. Dr.
Universitaire Ziekenhuizen KU Leuven