Sensory Rehabilitation in CIPN
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Patient self-Report Outcome Measure - Treatment-Induced Neuropathy Assessment Scale (TNAS)
研究概览
简要总结
This study is a cross-over RCT evaluating the effectiveness of 3 sessions a week apart of explicit sensory retraining to the lower extremities in individuals with CIPN versus usual care. The primary outcome measures are TNAS for subjective symptoms, VAS for pain and TUG for mobility. Additional outcome measures are FABS for balance, sensory assessments - monofilaments for touch threshold, LEPT for proprioception, a home exercise log and a satisfaction questionnaire.
详细描述
Chemotherapy Induced Peripheral Neuropathy (CIPN) is a neurological complication of chemotherapy, affecting between 50%-90% of the patients: up to 68% within the first month after chemotherapy, 60% after 3 months, and 30% after 6 months.
Neuropathic symptoms can persist in 11% to more than 80% of individuals post chemotherapy at one to three years following treatment and around 50% even after 5 years and more.
CIPN is associated with lower self-reported physical function and Quality of Life (QoL).
The clinical picture is typically sensory, with involvement of large and small sensory fibers. Motor and autonomic involvement is less frequent.
Damage to sensory nerve fibers is typically symmetrical. Sensory loss in a 'glove and stocking type' distribution leads to 'minus' symptoms (loss of function) including numbness in hands and feet, impaired perception of light touch, hypoalgesia and impaired proprioception, temperature and vibration sensation. Paradoxically, 'plus' features (gain of function) such as paresthesia (tingling like pins and needles), dysesthesia, allodynia and hyperalgesia appear simultaneously. CIPN can be functionally debilitating including impaired balance, walking slower and shorter steps and increased falls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The outcome assessor will not be aware of randomization and allocation. Primary investigator and statistician will receive data ready for analysis.
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
- •CIPN by self-report (present or absent) > 3 months after last chemotherapy treatment
- •age > 18.
排除标准
- •Pre-chemotherapy neuropathy/ sensory impairment
- •recurrent falls prior to chemotherapy (more than 2 per year)
- •CNS involvement
- •not ambulatory before chemotherapy
- •Hebrew proficiency not meeting questionnaires' needs.
研究组 & 干预措施
AB - early experimental treatment, later control usual care
AB - early experimental treatment, later control usual care
干预措施: Explicit Sensory Retraining for the lower extremities (Other)
AB - early experimental treatment, later control usual care
AB - early experimental treatment, later control usual care
干预措施: no treatment (Other)
BA - early control usual care, later experimental treatment
BA - early control usual care, later experimental treatment
干预措施: Explicit Sensory Retraining for the lower extremities (Other)
BA - early control usual care, later experimental treatment
BA - early control usual care, later experimental treatment
干预措施: no treatment (Other)
结局指标
主要结局
Patient self-Report Outcome Measure - Treatment-Induced Neuropathy Assessment Scale (TNAS)
时间窗: from randomization 3 months maximum
TNAS -Treatment-Induced Neuropathy Assessment Scale: patient-reported outcome measure of presence and severity of CIPN. Nine 0-10 question scale. score 0-90. A higher score is for higher CIPN symptom severity.
Functional - Balance and mobility outcome measure - Timed Up and Go test (TUG)
时间窗: from randomization to maximum 3 months followup
TUG -Timed Up and Go: Balance and mobility assessment. Serves as a fall prediction screening test. Measures time taken to raise from a chair walking 3 meters and re-sit.
Pain intensity: VAS - 0-100 mm visual scale
时间窗: from randomization to maximum 3 months
Pain intensity: VAS - 0-100 mm visual scale: self-reporting pain assessment from no pain to worst pain possible. We will ask for current pain and the worst pain during the last week
次要结局
- Tactile function assessment - Semmes Weinstein Monofilaments (SWM)(from randomization to maximum 3 months followup)
- FABS - Fullerton Advanced Balance Scale(from randomization to maximum 3 months)
- Proprioception of lower extremity: Lower Extremity Position Test (LEPT)(from randomization to maximum 3 months followup)
研究者
Rotem Merose
MD
Assaf-Harofeh Medical Center