Pain, Psychological, and Endocannabinoid Responses to Yoga in Breast Cancer Survivors With Chemotherapy-induced Neuropathic Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Change in cold pain threshold
研究概览
简要总结
This study evaluates the acute effect of aerobic exercise and yoga on pain, plasma levels of endocannabinoids, and mood (i.e., mood disturbance and anxiety). Participants will complete three separate sessions on different days. The first session is a familiarization session in which participants complete questionnaires and are familiarized with the experimental protocols. During the second and third sessions, outcomes are measured before and after the participants complete either 44 minutes of moderate aerobic exercise (i.e., walking on a treadmill) or 44 minutes of yoga.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of breast cancer (stage 0-III),
- •no evidence of active disease (i.e., recurrence, bone metastases, etc),
- •presence of painful polyneuropathy, with onset coinciding or developing after receiving chemotherapy agents that in the opinion of the research team is likely to have caused such symptoms,
- •at least six months since last active cancer treatment, with no further planned treatment (Note. active treatment is defined as surgery, chemotherapy, or radiation),
- •the participant agrees to use the safety stop feature on the treadmill if needed,
- •at least 18 years of age,
- •and their physicians has provided consent for them to participate in yoga and aerobic exercise sessions.
排除标准
- •Undergoing current chemotherapy or radiation treatment for cancer,
- •taking anticoagulant therapy,
- •uncontrolled medical conditions (i.e., uncontrolled hypertension, heart disease, stage 4 liver disease, end-stage renal disease, end-stage pulmonary disease, etc),
- •stroke or myocardial infarction in the past 6 months,
- •being pregnant or planning to become pregnant,
- •severe mobility constraints (e.g., confined to a wheelchair),
- •having a history of light headedness or fainting during blood draws or physical activity.
结局指标
主要结局
Change in cold pain threshold
时间窗: This will be measured 2 times during each experimental session- once before the assigned exercise task (i.e., baseline) and once upon task completion (i.e., approx. 50 mins later), approximately week 1 and week 2 on study.
The minimum cold temperature needed to elicit a pain response.
Change in Neuropathic Pain Sensations as determined by VAS
时间窗: This will be measured 2 times during each experimental session- once before the assigned exercise task (i.e., baseline) and once upon task completion (i.e., approx. 50 mins later), approximately week 1 and week 2 on study.
Visual analog scales (VAS) will be used to assess the intensity of the following sensations specific to neuropathic pain: pins and needles, tingles, stinging, and electrical pain sensations. The VAS is measured on a 100mm scale ranging from "No Pain" to "Worst Imaginable Pain."
次要结局
- Change in total mood disturbance (Profile of Mood States)(This will be measured 2 times during each experimental session- once before the assigned exercise task (i.e., baseline) and once upon task completion (i.e., approx. 50 mins later), approximately week 1 and week 2 on study.)
- Change in plasma concentration of 2-Arachidonoylglycerol (2-AG)(This will be measured 2 times during each experimental session- once before the assigned exercise task (i.e., baseline) and once upon task completion (i.e., approx. 50 mins later), approximately week 1 and week 2 on study.)