Multifaced Approach of Assessing Upper Extremity Proprioception in Breast Cancer Patients With Chemotherapy-Induced Peripheral Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- KU Leuven
- 入组人数
- 145
- 试验地点
- 1
- 主要终点
- Proprioceptive variability
研究概览
简要总结
Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most prevalent side-effects of chemotherapy, causing sensory and motor symptoms in patients. CIPN development is especially prevalent in chemotherapy treatment involving platinum- and taxane-based agents. The accompanying pain and deficits greatly impact the quality of life of these patients. Currently, patients are assessed for altered somatosensory using quantitative sensory testing (QST). The German Research Network on Neuropathic Pain (DFNS) has developed a standardized protocol which has been internationally recognized as approach for performing the QST. However, for proprioception the QST is limited to vibration assessments, making it limited as the only test to measure proprioception. Therefore, a comprehensive assessment of the proprioceptive functions is needed to better understand the influence CIPN has on the proprioception of patients, and thereby their quality of life.
In this project the effects of chemotherapy on somatosensory and proprioceptive functioning of breast cancer patients will be assessed in a cross-sectional study. This will be tested by comparing two groups of breast cancer patients and a healthy control group. Both patient groups will have undergone surgery for breast cancer, however, only one group will be tested after undergoing additional chemotherapy treatment. Thereby, the effects of chemotherapy between the surgery-only patient group and the chemotherapy patient group can tested. Furthermore, the investigators will compare both patient groups to sex- and age-matched healthy controls.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •General (applies to all participants):
- •At least 18 years of age at the time of signing the informed consent form
- •Voluntary written informed consent of the participant has been obtained prior to any screening procedures
- •Breast cancer surgery-only patient group:
- •The patient is an adult oncological person between 18 and 75 years old who has been treated for cancer
- •The participant has undergone breast cancer surgery but has not received any radiotherapy or chemotherapy treatment (yet).
- •The first session takes place between two and six weeks after breast cancer surgery.
- •The second session takes before any follow-up treatment for breast cancer (radiotherapy or chemotherapy).
- •Chemotherapy group:
- •The patient is an adult oncological person between 18 and 75 years old who has been treated for cancer.
- •The participant has undergone breast cancer surgery but has not received any radiotherapy (yet).
- •Participant has a history of treatment with platinum- or taxane-based chemotherapeutic agents, and this treatment has been terminated no later than 6 weeks before the first session.
- •Healthy control group:
- •No history of cancer or chemotherapy treatment
- •Sex and age-matched to patient sample
排除标准
- •General (applies to all participants):
- •Participant has a history of mental or physical disorders or neurological disease beyond those related to cancer treatments.
- •Participant uses any prescription or non-prescription drugs on a regular basis which, in the investigator's opinion, might confound the results of the study.
- •Participant is currently participating or has been involved in testing an investigational drug in another clinical study within the last 4 weeks which, in the investigator's opinion, might confound the results of the study.
- •Participant suffered from peripheral neuropathy prior to the chemotherapeutic treatment (Only for patients).
- •Participant has (a history of) a lesion in the central nervous system that is known to possibly cause neuropathic pain: e.g. spinal cord injury, infarction localized in the brainstem or thalamus, syringomyelia, multiple sclerosis, or any other disorder of the CNS that, in the investigator's opinion, may cause neuropathic pain.
- •If applicable: Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective contraceptive
研究组 & 干预措施
Surgery only
Breast cancer patients who have only undergone surgery for breast cancer and no other cancer treatment yet. Patients will be measured between 2 to 6 weeks post-surgery.
干预措施: Questionnaire - Edinburgh Handedness Assessment (Other)
Surgery only
Breast cancer patients who have only undergone surgery for breast cancer and no other cancer treatment yet. Patients will be measured between 2 to 6 weeks post-surgery.
干预措施: Questionnaire - QuickDash (Other)
Surgery only
Breast cancer patients who have only undergone surgery for breast cancer and no other cancer treatment yet. Patients will be measured between 2 to 6 weeks post-surgery.
干预措施: Questionnaire - EORTC QLQ-CIPN20 (Other)
Surgery only
Breast cancer patients who have only undergone surgery for breast cancer and no other cancer treatment yet. Patients will be measured between 2 to 6 weeks post-surgery.
干预措施: Questionnaire - Brief Pain Inventory (BPI) (Other)
Surgery only
Breast cancer patients who have only undergone surgery for breast cancer and no other cancer treatment yet. Patients will be measured between 2 to 6 weeks post-surgery.
干预措施: Questionnaire - Multidimensional Fatigue Inventory (MFI-20) (Other)
Surgery only
Breast cancer patients who have only undergone surgery for breast cancer and no other cancer treatment yet. Patients will be measured between 2 to 6 weeks post-surgery.
干预措施: Assessment of cognitive function - Montreal Cognitive Assessment (MoCA) (Other)
Surgery only
Breast cancer patients who have only undergone surgery for breast cancer and no other cancer treatment yet. Patients will be measured between 2 to 6 weeks post-surgery.
干预措施: Assessment of cognitive function - Spatial working memory task (Other)
Surgery only
Breast cancer patients who have only undergone surgery for breast cancer and no other cancer treatment yet. Patients will be measured between 2 to 6 weeks post-surgery.
干预措施: Robotic assessment of motor control - Visually guided reaching task (Diagnostic Test)
Surgery only
Breast cancer patients who have only undergone surgery for breast cancer and no other cancer treatment yet. Patients will be measured between 2 to 6 weeks post-surgery.
干预措施: Robotic assessment of proprioception - Bilateral whole arm position matching task (Diagnostic Test)
Surgery only
Breast cancer patients who have only undergone surgery for breast cancer and no other cancer treatment yet. Patients will be measured between 2 to 6 weeks post-surgery.
干预措施: Robotic assessment of proprioception - Whole arm perceptual boundary task (Diagnostic Test)
Surgery only
Breast cancer patients who have only undergone surgery for breast cancer and no other cancer treatment yet. Patients will be measured between 2 to 6 weeks post-surgery.
干预措施: Robotic assessment of proprioception - Perturbation task (Diagnostic Test)
Surgery only
Breast cancer patients who have only undergone surgery for breast cancer and no other cancer treatment yet. Patients will be measured between 2 to 6 weeks post-surgery.
干预措施: Robotic assessment of proprioception - Integration of vision and proprioception (Diagnostic Test)
Surgery only
Breast cancer patients who have only undergone surgery for breast cancer and no other cancer treatment yet. Patients will be measured between 2 to 6 weeks post-surgery.
干预措施: Robotic assessment of proprioception - Force matching (Diagnostic Test)
Surgery only
Breast cancer patients who have only undergone surgery for breast cancer and no other cancer treatment yet. Patients will be measured between 2 to 6 weeks post-surgery.
干预措施: Video-based assessment of proprioception - Wrist and shoulder bilateral position reproduction task (Diagnostic Test)
Surgery only
Breast cancer patients who have only undergone surgery for breast cancer and no other cancer treatment yet. Patients will be measured between 2 to 6 weeks post-surgery.
干预措施: Video-based assessment of proprioception - Finger-to-finger reaching task (Diagnostic Test)
Surgery only
Breast cancer patients who have only undergone surgery for breast cancer and no other cancer treatment yet. Patients will be measured between 2 to 6 weeks post-surgery.
干预措施: Assessment of fatigue - Visual analogue scale (Behavioral)
Surgery only
Breast cancer patients who have only undergone surgery for breast cancer and no other cancer treatment yet. Patients will be measured between 2 to 6 weeks post-surgery.
干预措施: Assessment of fear of movement - Visual analogue scale (Behavioral)
Surgery only
Breast cancer patients who have only undergone surgery for breast cancer and no other cancer treatment yet. Patients will be measured between 2 to 6 weeks post-surgery.
干预措施: QST assessment of sensory function - Mechanical detection threshold (Diagnostic Test)
Surgery only
Breast cancer patients who have only undergone surgery for breast cancer and no other cancer treatment yet. Patients will be measured between 2 to 6 weeks post-surgery.
干预措施: QST assessment of sensory function - Mechanical pain threshold (Diagnostic Test)
Surgery + Chemotherapy
Breast cancer patients who have undergone surgery for breast cancer and chemotherapy (with taxane- or platinum-based agents) and no other cancer treatment yet. Patients will be measured no later than 6 weeks after their last chemotherapy session.
干预措施: Questionnaire - EORTC QLQ-CIPN20 (Other)
Surgery only
Breast cancer patients who have only undergone surgery for breast cancer and no other cancer treatment yet. Patients will be measured between 2 to 6 weeks post-surgery.
干预措施: QST assessment of sensory function - Vibration detection threshold (Diagnostic Test)
Surgery only
Breast cancer patients who have only undergone surgery for breast cancer and no other cancer treatment yet. Patients will be measured between 2 to 6 weeks post-surgery.
干预措施: Assessment of sensory function - Bumps (Diagnostic Test)
Surgery only
Breast cancer patients who have only undergone surgery for breast cancer and no other cancer treatment yet. Patients will be measured between 2 to 6 weeks post-surgery.
干预措施: Assessment of range of motion (Other)
Surgery only
Breast cancer patients who have only undergone surgery for breast cancer and no other cancer treatment yet. Patients will be measured between 2 to 6 weeks post-surgery.
干预措施: Assessment of total relative arm volume - Arm volume (Other)
Surgery only
Breast cancer patients who have only undergone surgery for breast cancer and no other cancer treatment yet. Patients will be measured between 2 to 6 weeks post-surgery.
干预措施: Assessment of total relative arm volume - Hand volume (Other)
Surgery + Chemotherapy
Breast cancer patients who have undergone surgery for breast cancer and chemotherapy (with taxane- or platinum-based agents) and no other cancer treatment yet. Patients will be measured no later than 6 weeks after their last chemotherapy session.
干预措施: Questionnaire - Edinburgh Handedness Assessment (Other)
Surgery + Chemotherapy
Breast cancer patients who have undergone surgery for breast cancer and chemotherapy (with taxane- or platinum-based agents) and no other cancer treatment yet. Patients will be measured no later than 6 weeks after their last chemotherapy session.
干预措施: Questionnaire - QuickDash (Other)
Surgery + Chemotherapy
Breast cancer patients who have undergone surgery for breast cancer and chemotherapy (with taxane- or platinum-based agents) and no other cancer treatment yet. Patients will be measured no later than 6 weeks after their last chemotherapy session.
干预措施: Questionnaire - Brief Pain Inventory (BPI) (Other)
Surgery + Chemotherapy
Breast cancer patients who have undergone surgery for breast cancer and chemotherapy (with taxane- or platinum-based agents) and no other cancer treatment yet. Patients will be measured no later than 6 weeks after their last chemotherapy session.
干预措施: Questionnaire - Multidimensional Fatigue Inventory (MFI-20) (Other)
Surgery + Chemotherapy
Breast cancer patients who have undergone surgery for breast cancer and chemotherapy (with taxane- or platinum-based agents) and no other cancer treatment yet. Patients will be measured no later than 6 weeks after their last chemotherapy session.
干预措施: Assessment of cognitive function - Montreal Cognitive Assessment (MoCA) (Other)
Surgery + Chemotherapy
Breast cancer patients who have undergone surgery for breast cancer and chemotherapy (with taxane- or platinum-based agents) and no other cancer treatment yet. Patients will be measured no later than 6 weeks after their last chemotherapy session.
干预措施: Assessment of cognitive function - Spatial working memory task (Other)
Surgery + Chemotherapy
Breast cancer patients who have undergone surgery for breast cancer and chemotherapy (with taxane- or platinum-based agents) and no other cancer treatment yet. Patients will be measured no later than 6 weeks after their last chemotherapy session.
干预措施: Robotic assessment of motor control - Visually guided reaching task (Diagnostic Test)
Surgery + Chemotherapy
Breast cancer patients who have undergone surgery for breast cancer and chemotherapy (with taxane- or platinum-based agents) and no other cancer treatment yet. Patients will be measured no later than 6 weeks after their last chemotherapy session.
干预措施: Robotic assessment of proprioception - Bilateral whole arm position matching task (Diagnostic Test)
Surgery + Chemotherapy
Breast cancer patients who have undergone surgery for breast cancer and chemotherapy (with taxane- or platinum-based agents) and no other cancer treatment yet. Patients will be measured no later than 6 weeks after their last chemotherapy session.
干预措施: Robotic assessment of proprioception - Whole arm perceptual boundary task (Diagnostic Test)
Surgery + Chemotherapy
Breast cancer patients who have undergone surgery for breast cancer and chemotherapy (with taxane- or platinum-based agents) and no other cancer treatment yet. Patients will be measured no later than 6 weeks after their last chemotherapy session.
干预措施: Robotic assessment of proprioception - Perturbation task (Diagnostic Test)
Surgery + Chemotherapy
Breast cancer patients who have undergone surgery for breast cancer and chemotherapy (with taxane- or platinum-based agents) and no other cancer treatment yet. Patients will be measured no later than 6 weeks after their last chemotherapy session.
干预措施: Robotic assessment of proprioception - Integration of vision and proprioception (Diagnostic Test)
Surgery + Chemotherapy
Breast cancer patients who have undergone surgery for breast cancer and chemotherapy (with taxane- or platinum-based agents) and no other cancer treatment yet. Patients will be measured no later than 6 weeks after their last chemotherapy session.
干预措施: Robotic assessment of proprioception - Force matching (Diagnostic Test)
Surgery + Chemotherapy
Breast cancer patients who have undergone surgery for breast cancer and chemotherapy (with taxane- or platinum-based agents) and no other cancer treatment yet. Patients will be measured no later than 6 weeks after their last chemotherapy session.
干预措施: Video-based assessment of proprioception - Wrist and shoulder bilateral position reproduction task (Diagnostic Test)
Surgery + Chemotherapy
Breast cancer patients who have undergone surgery for breast cancer and chemotherapy (with taxane- or platinum-based agents) and no other cancer treatment yet. Patients will be measured no later than 6 weeks after their last chemotherapy session.
干预措施: Video-based assessment of proprioception - Finger-to-finger reaching task (Diagnostic Test)
Surgery + Chemotherapy
Breast cancer patients who have undergone surgery for breast cancer and chemotherapy (with taxane- or platinum-based agents) and no other cancer treatment yet. Patients will be measured no later than 6 weeks after their last chemotherapy session.
干预措施: Assessment of fatigue - Visual analogue scale (Behavioral)
Surgery + Chemotherapy
Breast cancer patients who have undergone surgery for breast cancer and chemotherapy (with taxane- or platinum-based agents) and no other cancer treatment yet. Patients will be measured no later than 6 weeks after their last chemotherapy session.
干预措施: Assessment of fear of movement - Visual analogue scale (Behavioral)
Surgery + Chemotherapy
Breast cancer patients who have undergone surgery for breast cancer and chemotherapy (with taxane- or platinum-based agents) and no other cancer treatment yet. Patients will be measured no later than 6 weeks after their last chemotherapy session.
干预措施: QST assessment of sensory function - Mechanical detection threshold (Diagnostic Test)
Surgery + Chemotherapy
Breast cancer patients who have undergone surgery for breast cancer and chemotherapy (with taxane- or platinum-based agents) and no other cancer treatment yet. Patients will be measured no later than 6 weeks after their last chemotherapy session.
干预措施: QST assessment of sensory function - Mechanical pain threshold (Diagnostic Test)
Surgery + Chemotherapy
Breast cancer patients who have undergone surgery for breast cancer and chemotherapy (with taxane- or platinum-based agents) and no other cancer treatment yet. Patients will be measured no later than 6 weeks after their last chemotherapy session.
干预措施: QST assessment of sensory function - Vibration detection threshold (Diagnostic Test)
Surgery + Chemotherapy
Breast cancer patients who have undergone surgery for breast cancer and chemotherapy (with taxane- or platinum-based agents) and no other cancer treatment yet. Patients will be measured no later than 6 weeks after their last chemotherapy session.
干预措施: Assessment of sensory function - Bumps (Diagnostic Test)
Surgery + Chemotherapy
Breast cancer patients who have undergone surgery for breast cancer and chemotherapy (with taxane- or platinum-based agents) and no other cancer treatment yet. Patients will be measured no later than 6 weeks after their last chemotherapy session.
干预措施: Assessment of range of motion (Other)
Surgery + Chemotherapy
Breast cancer patients who have undergone surgery for breast cancer and chemotherapy (with taxane- or platinum-based agents) and no other cancer treatment yet. Patients will be measured no later than 6 weeks after their last chemotherapy session.
干预措施: Assessment of total relative arm volume - Arm volume (Other)
Surgery + Chemotherapy
Breast cancer patients who have undergone surgery for breast cancer and chemotherapy (with taxane- or platinum-based agents) and no other cancer treatment yet. Patients will be measured no later than 6 weeks after their last chemotherapy session.
干预措施: Assessment of total relative arm volume - Hand volume (Other)
Healthy control
Healthy sex- and age-matched controls. Participants should have no history of any neurological disorder or cancer.
干预措施: Questionnaire - Edinburgh Handedness Assessment (Other)
Healthy control
Healthy sex- and age-matched controls. Participants should have no history of any neurological disorder or cancer.
干预措施: Questionnaire - QuickDash (Other)
Healthy control
Healthy sex- and age-matched controls. Participants should have no history of any neurological disorder or cancer.
干预措施: Questionnaire - EORTC QLQ-CIPN20 (Other)
Healthy control
Healthy sex- and age-matched controls. Participants should have no history of any neurological disorder or cancer.
干预措施: Questionnaire - Brief Pain Inventory (BPI) (Other)
Healthy control
Healthy sex- and age-matched controls. Participants should have no history of any neurological disorder or cancer.
干预措施: Questionnaire - Multidimensional Fatigue Inventory (MFI-20) (Other)
Healthy control
Healthy sex- and age-matched controls. Participants should have no history of any neurological disorder or cancer.
干预措施: Assessment of cognitive function - Montreal Cognitive Assessment (MoCA) (Other)
Healthy control
Healthy sex- and age-matched controls. Participants should have no history of any neurological disorder or cancer.
干预措施: Assessment of cognitive function - Spatial working memory task (Other)
Healthy control
Healthy sex- and age-matched controls. Participants should have no history of any neurological disorder or cancer.
干预措施: Robotic assessment of motor control - Visually guided reaching task (Diagnostic Test)
Healthy control
Healthy sex- and age-matched controls. Participants should have no history of any neurological disorder or cancer.
干预措施: Robotic assessment of proprioception - Bilateral whole arm position matching task (Diagnostic Test)
Healthy control
Healthy sex- and age-matched controls. Participants should have no history of any neurological disorder or cancer.
干预措施: Robotic assessment of proprioception - Whole arm perceptual boundary task (Diagnostic Test)
Healthy control
Healthy sex- and age-matched controls. Participants should have no history of any neurological disorder or cancer.
干预措施: Robotic assessment of proprioception - Perturbation task (Diagnostic Test)
Healthy control
Healthy sex- and age-matched controls. Participants should have no history of any neurological disorder or cancer.
干预措施: Robotic assessment of proprioception - Integration of vision and proprioception (Diagnostic Test)
Healthy control
Healthy sex- and age-matched controls. Participants should have no history of any neurological disorder or cancer.
干预措施: Robotic assessment of proprioception - Force matching (Diagnostic Test)
Healthy control
Healthy sex- and age-matched controls. Participants should have no history of any neurological disorder or cancer.
干预措施: Video-based assessment of proprioception - Wrist and shoulder bilateral position reproduction task (Diagnostic Test)
Healthy control
Healthy sex- and age-matched controls. Participants should have no history of any neurological disorder or cancer.
干预措施: Video-based assessment of proprioception - Finger-to-finger reaching task (Diagnostic Test)
Healthy control
Healthy sex- and age-matched controls. Participants should have no history of any neurological disorder or cancer.
干预措施: Assessment of fatigue - Visual analogue scale (Behavioral)
Healthy control
Healthy sex- and age-matched controls. Participants should have no history of any neurological disorder or cancer.
干预措施: Assessment of fear of movement - Visual analogue scale (Behavioral)
Healthy control
Healthy sex- and age-matched controls. Participants should have no history of any neurological disorder or cancer.
干预措施: QST assessment of sensory function - Mechanical detection threshold (Diagnostic Test)
Healthy control
Healthy sex- and age-matched controls. Participants should have no history of any neurological disorder or cancer.
干预措施: QST assessment of sensory function - Mechanical pain threshold (Diagnostic Test)
Healthy control
Healthy sex- and age-matched controls. Participants should have no history of any neurological disorder or cancer.
干预措施: QST assessment of sensory function - Vibration detection threshold (Diagnostic Test)
Healthy control
Healthy sex- and age-matched controls. Participants should have no history of any neurological disorder or cancer.
干预措施: Assessment of sensory function - Bumps (Diagnostic Test)
Healthy control
Healthy sex- and age-matched controls. Participants should have no history of any neurological disorder or cancer.
干预措施: Assessment of range of motion (Other)
Healthy control
Healthy sex- and age-matched controls. Participants should have no history of any neurological disorder or cancer.
干预措施: Assessment of total relative arm volume - Arm volume (Other)
Healthy control
Healthy sex- and age-matched controls. Participants should have no history of any neurological disorder or cancer.
干预措施: Assessment of total relative arm volume - Hand volume (Other)
结局指标
主要结局
Proprioceptive variability
时间窗: Baseline (across two assessment visits within 10 days of each other)
Within-subject variability/precision of proprioceptive estimates during repeated matching or reaching trials, indicating consistency of position sense. Measures will be derived from robotic tasks (including arm position matching, and perceptual boundary (slope) tasks) and video-based DeepLabCut tasks (including the joint position matching and finger-to-finger reaching tasks). Example metrics: standard deviation of repeated matches or within-subject SD of errors.
次要结局
- Proprioceptive bias(Baseline (across two assessment visits within 10 days of each other))
- Proprioceptive accuracy(Baseline (across two assessment visits within 10 days of each other))
- Force perception accuracy and variability(Baseline (during first assessment visit))
- Multisensory integration performance(Baseline (during first assessment visit))
- Reaction to Proprioceptive perturbation(Baseline (during first assessment visit))
- Somatosensory detection thresholds(Baseline (during second assessment visit))
- Somatosensory pain thresholds(Baseline (during second assessment visit))
- Somatosensory Vibration detection thresholds(Baseline (during second assessment visit))
- Tactile threshold(Baseline (during second assessment visit))