Psychophysical Studies of Cancer Therapy-Induced Pain: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 450
- 试验地点
- 2
- 主要终点
- Participant Heat + Cold Pain Threshold
研究概览
简要总结
The Aim of this Study is to examine the feasibility of using quantitative sensory testing procedures, widely applied to the experimental study of sensory processing in humans both with and without various pain syndromes, to now characterize the psychophysical properties of neuropathic pain that has developed as a consequence of cancer therapy. Skin punch biopsies will be performed in patients with chemotherapy-induced pain to determine whether the impairment of nerve function is due to actual retraction or loss of innervation to the skin in areas affected by sensory disturbance.
详细描述
Study Participation:
Participants will be contacted either before their initiation of chemotherapy or following their referral to pain management service for neuropathic cancer treatment-related pain.
The sensory tests will take about 1 hour to complete. These tests will seek to find the threshold (a measure of sensitivity) at which you perceive stimuli, such as touch, coolness, warmth, hot/cold feeling and pinprick. You will be asked to rate the intensity of each of these stimuli that you perceive to be painful. You will also be asked to rate the intensity of stimuli that are at a fixed intensity above the pain threshold for most people. Your skin temperature using a radiometer, a scan of your fingers and/or toes, grooved peg board, a timed task to place pegs in slots, and pain scale rating will be collected. Each part of the sensory test are optional and will be collected when possible.
You may either be tested at repeated intervals throughout your chemotherapy or at later follow-up dates to check the length of symptoms.
Length of Study:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Since moderate pain, albeit brief, will be induced, this feasibility project will be limited to consenting adults, 18 years old or older, in which there is also a well established QST database.
- •The subjects must be able to understand the nature of the study and have signed consent.
- •The patients must either: a) have pain that has developed as a consequence of cancer therapy with either vinca alkaloids, taxanes, bortezomib, thalidomide, platinum-based compounds or ionizing irradiation. OR b) have no pain that has developed as a consequence of cancer therapy, and are just entering chemotherapy with taxanes, vinka alkaloids, bortezomib, thalidomide, or platinum-based compounds
- •(For Healthy Controls) Willing to participate and have signed an informed consent.
排除标准
- •Patients who refuse to participate or who are determined incapable of completing the research.
- •(For Healthy Controls) Receiving anti-coagulants, immunosuppressed or diabetic.
结局指标
主要结局
Participant Heat + Cold Pain Threshold
时间窗: 1 Hour Sensory Testing: Baseline + testing at repeated intervals throughout chemotherapy or at later follow-ups.
Participant Mechanical Testing Results <Touch Detection Threshold; Sharpness Threshold + Pain Ratings to Needle Probe; Bump Test>
时间窗: 1 Hour Sensory Testing: Baseline + testing at repeated intervals throughout chemotherapy or at later follow-ups.
次要结局
未报告次要终点