Diet and Exercise After Pancreatic Cancer: Clinical and Functional Outcomes (Non Canonical WNT Signaling in Colorectal Cancer)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Feasibility - Recruitment
研究概览
简要总结
Determine feasibility of a randomized controlled trial (RCT) in pancreatic (& other foregut) cancer patients comparing the effects of diet alone vs. diet+exercise on functional and clinical outcomes.
详细描述
Foregut cancers such as pancreatic cancer cause significant side effects and poorer health-related quality of life (QOL), as well as a 5-year survival rate of only 6%. Importantly, the reduction in physical functioning caused by this cancer and its therapies is associated with higher mortality risk. Although multiple studies in more prevalent cancer types support exercise benefits (e.g., improved physical functioning), data cannot be generalized from one cancer type to another. Little is known about exercise feasibility and benefits in pancreatic (& other foregut) cancer patients, and no data regarding potential mechanistic outcomes that may explain the link between poor physical performance status and cancer survival have been reported. We will enroll 20 patients with pancreatic adenocarcinoma (or other foregut cancer) who are expected to undergo surgical resection or who are within 3 years of surgical resection, in a pilot project involving a 6-month home-based lifestyle intervention (diet along versus diet+exercise). Research assessments will be done pre-surgery (if applicable), post-surgery (and prior to starting the intervention), 3 months, and 6 months post-surgery. Intervention counseling will be delivered using visual communication (e.g., Skype). Participants will be provided a computer tablet for the intervention with participants randomized to receive exercise counseling also receiving a fitness bracelet to facilitate counseling by the certified Cancer Exercise Trainer. Our primary study aim is to determine feasibility of a randomized controlled trial (RCT) in pancreatic cancer patients comparing the effects of diet alone with diet+exercise on pancreatic cancer-related functional and disease outcomes; feasibility measures include recruitment, retention, intervention adherence, assessment completion, adverse events, and participant satisfaction. Our secondary study aim is to determine the effect of diet+exercise compared with diet alone on physical functioning and QOL. Also, we will draw and store blood samples so that additional funds can be requested to test intervention effects on biomarkers of cancer risk (e.g., tumor immunity, inflammatory cytokines, etc.). The goal of the study is to advance the exercise oncology field into an understudied cancer type and develop an intervention that will improve the survivorship care of pancreatic cancer patients through distance-delivered counseling methods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •adult 18 years of age or older with resectable foregut cancer for whom surgery is planned (includes "borderline resectable" if deemed appropriate by surgical investigators) or has occurred within the past 3 years
- •English speaking
- •Eastern Cooperative Technology Group (ECOG) performance status of 0,1 or
- •able to ambulate without assistance
- •able to obtain medical clearance
排除标准
- •foregut cancer recurrence
- •dementia or organic brain syndrome
- •severe emotional distress
- •medical, psychological or social characteristic that would interfere with the ability to fully participate in program activities and assessments
- •another diagnosis of cancer in the past 5 years (not including skin or cervical cancer in situ).
- •oncologist refuses to allow screening for possible study participation
- •current participation in another exercise trial
结局指标
主要结局
Feasibility - Recruitment
时间窗: Baseline
Number of participants excluded or not agreeing to participate
Feasibility - Adherence to study protocol activities
时间窗: Throughout 6 month study period
Feasibility measure (e.g. percent of assessments completed, percent of counseling sessions completed, etc.)
Feasibility - Attrition rates
时间窗: Throughout 6 month study period
Number of participants who dropout or are withdrawn
Feasibility - Adverse events
时间窗: Throughout 6 month study period
Recorded by staff
Feasibility - Participant satisfaction
时间窗: At conclusion of 6 month study period
Survey
次要结局
- Eastern Cooperative Oncology Group (ECOG) performance status(At 4 timepoints during the 6 month study (pre-surgery if applicable, post-surgery/prior to starting the intervention, 3 months and 6 months))
- Survival rates(At conclusion of 6 month study)
- Completion of pancreatic cancer treatment(At conclusion of 6 month study)
- Prognostic blood cytokine biomarkers(At 4 timepoints during the 6 month study (pre-surgery if applicable, post-surgery/prior to starting the intervention, 3 months and 6 months))
- Prognostic blood tumor immunity biomarkers(At 4 timepoints during the 6 month study (pre-surgery if applicable, post-surgery/prior to starting the intervention, 3 months and 6 months))
- Quality of life (assessed using the Functional Assessment of Cancer Therapy index)(At 4 timepoints during the 6 month study (pre-surgery if applicable, post-surgery/prior to starting the intervention, 3 months and 6 months))
- Objective physical functioning(At 4 timepoints during the 6 month study (pre-surgery if applicable, post-surgery/prior to starting the intervention, 3 months and 6 months))
- CA 19-9 (tumor markers)(At 4 timepoints during the 6 month study (pre-surgery if applicable, post-surgery/prior to starting the intervention, 3 months and 6 months))
- Pancreatic cancer recurrence rates(At conclusion of 6 month study)
- Wearable activity monitor (weekly minutes of physical activity)(At 4 timepoints during the 6 month study (pre-surgery if applicable, post-surgery/prior to starting the intervention, 3 months and 6 months))
研究者
Laura Q. Rogers, MD, MPH
Primary Investigator
University of Alabama at Birmingham