A Phase II Study of the Effects of Physical Activity and Low-Dose Ibuprofen on Cognitive Function in Cancer Patients Undergoing Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Memory Performance as Assessed by Computerized Cognitive Assessment - Mean Values by Arm
研究概览
简要总结
This research seeks to determine if a combination of low-dose ibuprofen along with a structured home-based walking and progressive resistance exercise program, EXCAP, will be effective in reducing cognitive difficulties among cancer patients receiving chemotherapy.
详细描述
To conduct a feasibility pilot to assess preliminary efficacy of a 6 week course of ibuprofen (200 mg BID with does 8 hours apart) and a structured home based walking/progressive resistance program, EXCAP, alone or together, on cognitive function and levels of inflammatory molecules among cancer patients receiving chemotherapy (beginning at cycle 2). If these interventions prove to be useful and have potential benefit, they could have a substantial impact on treating cognitive difficulties experienced by cancer patients as well as improve quality of life. Moreover, if there is an effect of these interventions on cognitive functioning and inflammation, we will gain more knowledge of a possible mechanism of chemotherapy-related cognitive difficulties.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Must report cognitive difficulties of 3 or higher on a 0-10 scale
- •Must provide informed consent
- •Be able to read English
- •Have a primary diagnosis of cancer
- •Be able to swallow medication
- •Women of child-bearing potential must not be pregnant or become pregnant during the 6 week study
- •Agree not to take NSAIDs during the 6 week intervention period
- •Be scheduled to receive at least 2 additional cycles of oral or IV chemotherapy over the 42-day study period.
- •Must have the approval of their treating physician to begin the exercise program and receive the ibuprofen
- •Must be over 18 years of age
排除标准
- •Currently taking a consistent dosage of a NSAID at least 3 days a week for the last 3 months that is over 400mg daily
- •Have an allergy to ibuprofen
- •Be identified as in active or maintenance stage of exercise behavior as assessed by the single-item exercise stages of change short form
- •have physical limitations that contraindicate participation in sub-maximal physiological fitness testing or a low to moderate home-based walking and progressive resistance program
- •have a history of peptic ulcer disease within the last 12 months
- •Diagnosed with a neurodegenerative disease
- •Had a myocardial infraction within the past 6 months
- •Patients with a neutropenic episode during the first cycle of chemotherapy or at high risk for a neutropenic episode during future chemotherapy cycles at the treating physicians discretion
- •Have confirmed metastatic disease to the central nervous system
- •Have been hospitalized for a major psychiatric illness within the last 5 years
研究组 & 干预措施
Placebo and Home-Based Exercise
200mg placebo (taken twice a day at least 8 hours apart) for a period of 6 weeks and a progressive walking and resistance band exercise program called Exercise for Cancer Patient (EXCAP) for a period of 6 weeks.
干预措施: Home-Based Exercise (Behavioral)
Placebo and Home-Based Exercise
200mg placebo (taken twice a day at least 8 hours apart) for a period of 6 weeks and a progressive walking and resistance band exercise program called Exercise for Cancer Patient (EXCAP) for a period of 6 weeks.
干预措施: Placebo (Drug)
Ibuprofen 200mg BID, Home-Based Exercise
200mg ibuprofen (taken twice a day at least 8 hours apart) and a progressive walking and resistance band exercise program called Exercise for Cancer Patient (EXCAP) for a period of 6 weeks.
干预措施: Ibuprofen (Drug)
Ibuprofen 200mg BID, Home-Based Exercise
200mg ibuprofen (taken twice a day at least 8 hours apart) and a progressive walking and resistance band exercise program called Exercise for Cancer Patient (EXCAP) for a period of 6 weeks.
干预措施: Home-Based Exercise (Behavioral)
Placebo
200mg placebo (taken twice a day at least 8 hours apart) for a period of 6 weeks.
干预措施: Placebo (Drug)
Ibuprofen 200 mg BID
200mg ibuprofen (taken twice a day at least 8 hours apart) for a period of 6 weeks.
干预措施: Ibuprofen (Drug)
结局指标
主要结局
Memory Performance as Assessed by Computerized Cognitive Assessment - Mean Values by Arm
时间窗: Baseline and 6 weeks
Memory performances (percent correct across delays) as assessed by the objective CANTAB delayed matching to sample task Percentage correct range (0 to 100) Higher percentage is better
次要结局
- Cognitive Functioning Score as Assessed by FACT-COG Questionnaire - Perceived Cognitive Impairment (PCI) - Mean Values by Arm(Baseline and 6 weeks)
研究者
Michelle Janelsins, PhD, MPH
Associate Professor
University of Rochester