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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
15
Diet 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 diet counseling.
Diet and exercise 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 diet and exercise counseling.
University of Alabama at Birmingham
Birmingham, Alabama, United States
Feasibility - Recruitment
Number of participants excluded or not agreeing to participate
Time frame: Baseline
Feasibility - Adherence to study protocol activities
Feasibility measure (e.g. percent of assessments completed, percent of counseling sessions completed, etc.)
Time frame: Throughout 6 month study period
Feasibility - Attrition rates
Number of participants who dropout or are withdrawn
Time frame: Throughout 6 month study period
Feasibility - Adverse events
Recorded by staff
Time frame: Throughout 6 month study period
Feasibility - Participant satisfaction
Survey
Time frame: At conclusion of 6 month study period
Eastern Cooperative Oncology Group (ECOG) performance status
Preliminary effect size
Time frame: 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)
Preliminary effect size
Time frame: 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
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Preliminary effect size
Time frame: 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)
Exploratory data related to within and between group (diet and diet+exercise) differences
Time frame: At 4 timepoints during the 6 month study (pre-surgery if applicable, post-surgery/prior to starting the intervention, 3 months and 6 months)
Completion of pancreatic cancer treatment
Exploratory data related to within and between group (diet and diet+exercise) differences
Time frame: At conclusion of 6 month study
Survival rates
Exploratory data related to within and between group (diet and diet+exercise) differences
Time frame: At conclusion of 6 month study
Pancreatic cancer recurrence rates
Exploratory data related to within and between group (diet and diet+exercise) differences
Time frame: At conclusion of 6 month study
Prognostic blood cytokine biomarkers
Exploratory data related to within and between group (diet and diet+exercise) differences
Time frame: 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
Exploratory data related to within and between group (diet and diet+exercise) differences
Time frame: At 4 timepoints during the 6 month study (pre-surgery if applicable, post-surgery/prior to starting the intervention, 3 months and 6 months)
Wearable activity monitor (weekly minutes of physical activity)
Exploratory data related to within and between group (diet and diet+exercise) differences
Time frame: At 4 timepoints during the 6 month study (pre-surgery if applicable, post-surgery/prior to starting the intervention, 3 months and 6 months)