Pilot Study for the Effect of Exercise Intervention in Breast Cancer Patients With Arthralgias Receiving Aromatase Inhibitors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pain Disability Index
研究概览
简要总结
The objective of this study is to determine if patients taking aromatase inhibitors (AI), who are experiencing joint discomfort and stiffness, would have reduction in this discomfort and stiffness by participating in a directed exercise program. The overarching objective is to improve patient compliance with the medication and ultimately clinical outcome.
In this pilot study, we will utilize a scientific approach for proof of concept employing both objective (inflammatory cytokine profiles and Physical Therapy (PT) measurements) and subjective (patient perception) methods to support an evidence based clinical plan. Patients will be divided into two cohorts. Group A will receive AI therapy with a directed exercise program. Group B will receive AI therapy without a directed exercise program. Data will be collected when both cohorts of patients enroll in the study, at the end of PT for Group A and, at the end of 8 weeks for Group B. At these time points, both groups will undergo a PT evaluation; have blood drawn for cytokine profiles; answer questions on an iPad that includes: the Pain Disability Index, the PHQ-4 (Psycological Health Questionaire depression scale, and pain level scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women over age 40 with histological evidence of hormone receptor positive breast cancer.
- •Post- menopausal
- •Adjuvant AI therapy.
- •Significant joint discomfort/stiffness when attempting activities of daily living which began or significantly increased after initiation of AI therapy.
- •Currently not in an active directed exercise program (>60 minutes 2x/wk)
排除标准
- •Preexisting RA or fibromyalgia.
- •Systemic metastasis
- •ECOG performance status of greater than
研究组 & 干预措施
Arm A
8 week directed exercise program
干预措施: Arm A Directed exercise program (Other)
Arm B
No directed exercise other than patients normal level of activity
干预措施: Observation (Other)
结局指标
主要结局
Pain Disability Index
时间窗: 8 weeks
directed exercise program will improve patient response to the pain disability index survey.
次要结局
- Plasma levels of inflammatory markers.(8 weeks)
