Comprehensive Lifestyle Improvement Program for Men With Prostate Cancer2 (CLIPP2) (CLIPP2)
研究概览
详细说明
INTRODUCTION:
Androgen deprivation therapy (ADT) has been demonstrated to improve disease free and over-all survival in men with prostate cancer (PCa).
ADT for PCa is associated with adverse cardio-metabolic effects such as reduced libido, hot flashes, metabolic syndrome, diabetes, myocardial infarction and stroke. This reduces quality of life (QoL) and potentially affects mortality.
There is paucity of data regarding comprehensive lifestyle interventions in men on ADT for Pca. Existing studies used non-standardized interventions or lack data on metabolic risk factors.
CLIPP is designed to address these gaps by using an intervention modelled after the Diabetes Prevention Program (DPP) with an emphasis on low carbohydrate and a Keto Diet, a standardized multi-component intervention with demonstrated effectiveness in reducing diabetes risk factors that has been successfully adapted for multiple disease types including breast cancer.
INTERVENTION:
- 24 Weeks
- Health Coaching Weekly
- Serum & Urine Baseline, Week 12 and Week 24
- Anthropometric Measures
- Questionnaires
- BMI Measurements
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Tracey Smith
- 电话号码：5206268038
- 邮箱：traceysmith@email.arizona.edu
研究联系人备份
- 姓名：Amit Algotar, MD, PhD, MPH
- 电话号码：5206268038
- 邮箱：algotar@email.arizona.edu
学习地点
-
-
Arizona
-
Gilbert、Arizona、美国、85234
- 招聘中
- Banner MD Anderson Cancer Center
-
接触：
- Tracey Smith
- 电话号码：520-626-8038
- 邮箱：traceysmith@arizona.edu
-
Tucson、Arizona、美国、85714
- 尚未招聘
- University of Arizona Cancer Center
-
接触：
- Tracey Smith
- 电话号码：520-626-8038
- 邮箱：traceysmith@email.arizona.edu
-
首席研究员：
- Amit Algotar, MD
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Diagnosed with prostate cancer Stage I, II or III
- On androgen deprivation therapy with last 5 years
- Willing to participate in a lifestyle modification program
- Willing to modify diet and eating practices
- Willing to participate in blood collection, urine collection and measurements
- Minimum of 30 days since participating in another study/trial
- English speaking
- 40 to 80 years of age
- BMI >25%
Exclusion Criteria:
- Currently participating in another study or trial
- Currently in hospice
- Inability to walk two city blocks
- Inability to comprehend informed consent or procedural requirements
- Digestive Diseases (IBD, Diverticulitis, etc) that might prevent him from increasing fruit and vegetable intake
- Subjects already following an intensive lifestyle modification plan
- BMI <25%
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：CLIPP2
24 Week Lifestyle Modification Intervention
|
Diabetes Prevention Program and Comprehensive Lifestyle Improvement Program with emphasis on a low carbohydrate and Keto diet, physical activity, sleep optimization and stress management.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Reach Recruiting Target
大体时间：6 Months
|
Recruit 36 men with prostate cancer who have been on androgen deprivation therapy within the last 5 years.
|
6 Months
|
|
Retention of Participants
大体时间：6 Months
|
75% retention rate
|
6 Months
|
|
Adherence to Intervention
大体时间：6 Months
|
75% attendance rate throughout 24 intervention visits
|
6 Months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Fasting Glucose
大体时间：6 Months
|
Unit of Measure Mg/dL
|
6 Months
|
|
Hemoglobin A1c
大体时间：6 Months
|
Unit of Measure %
|
6 Months
|
|
Lipid Panel
大体时间：6 Months
|
Unit of Measure Mg/dl
|
6 Months
|
|
CBC
大体时间：6 Months
|
Unit of Measure Mg/dL
|
6 Months
|
|
CMP
大体时间：6 Months
|
Unit of Measure Mg/dL
|
6 Months
|
|
Global Quality of Life Questionnaire
大体时间：6 Months
|
PROMIS Scale v 1.2 Global Health.
Scale Measurements 1 to 5 1=Poor 5=Excellent
|
6 Months
|
|
Specific Quality of Life Questionnaire
大体时间：6 Months
|
Expanded Prostate Cancer Index Composite Short Form (EPIC-26) Scale of Measurement 0 to 4. 0=No Problem 4=Big Problem
|
6 Months
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Inflammatory Pathways Associated with Prostate Cancer
大体时间：6 Months
|
Inflammation markers measured will include Interleukin-6, Interleukin 1-beta, Interleukin-8, stromal cell derived factor 1-alpha & basic fibroblast growth factor.
|
6 Months
|
|
Angiogenic Pathways Associated with Prostate Cancer
大体时间：6 Months
|
Determine the effect of comprehensive lifestyle modification intervention on angiogenesis, markers, important mechanisms for prostate cancer progression using blood, serum and urine.
Angiogenesis markers will include vascular endothelial growth factor & plasma placental growth factor using Enzyme Linked Immunosorbent Assay (ELISA)
|
6 Months
|
合作者和调查者
调查人员
- 首席研究员：Amit Algotar, MD, PhD, MPH、University of Arizona
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.