Diet and Exercise After Pancreatic Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Diet and Exercise After Pancreatic Cancer: Clinical and Functional Outcomes (Non Canonical WNT Signaling in Colorectal Cancer)

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Behavioral: Diet Only
* Behavioral: Diet + Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 2. able to ambulate without assistance able to obtain medical clearance Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Diet only<br>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. | Behavioral: Diet Only<br>* 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.<br>|
| Experimental: Diet + Exercise<br>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 also receiving a fitness bracelet to facilitate counseling by the certified Cancer Exercise Trainer. | Behavioral: Diet + Exercise<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility - Recruitment | Number of participants excluded or not agreeing to participate | Baseline | 
| Feasibility - Adherence to study protocol activities | Feasibility measure (e.g. percent of assessments completed, percent of counseling sessions completed, etc.) | Throughout 6 month study period | 
| Feasibility - Attrition rates | Number of participants who dropout or are withdrawn | Throughout 6 month study period | 
| Feasibility - Adverse events | Recorded by staff | Throughout 6 month study period | 
| Feasibility - Participant satisfaction | Survey | At conclusion of 6 month study period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eastern Cooperative Oncology Group (ECOG) performance status | Preliminary effect size | 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 | 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 | Preliminary effect size | 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 | 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 | At conclusion of 6 month study | 
| Survival rates | Exploratory data related to within and between group (diet and diet+exercise) differences | At conclusion of 6 month study | 
| Pancreatic cancer recurrence rates | Exploratory data related to within and between group (diet and diet+exercise) differences | At conclusion of 6 month study | 
| Prognostic blood cytokine biomarkers | Exploratory data related to within and between group (diet and diet+exercise) differences | 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 | 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 | At 4 timepoints during the 6 month study (pre-surgery if applicable, post-surgery/prior to starting the intervention, 3 months and 6 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer of Pancreas, Neoplasms, Pancreatic, Pancreas Cancer, Pancreas Neoplasms, Cancer of the Pancreas, Pancreatic Cancer, Foregut Cancer