Clinical trial NCT03187028: Diet and Exercise After Pancreatic Cancer
Official title: Diet and Exercise After Pancreatic Cancer: Clinical and Functional Outcomes (Non Canonical WNT Signaling in Colorectal Cancer)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Cancer
Keywords: Cancer of Pancreas
Neoplasms, Pancreatic
Pancreas Cancer
Pancreas Neoplasms
Cancer of the Pancreas
Pancreatic Cancer
Foregut Cancer
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2017-06-14
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility - Recruitment
timeFrame: Baseline
measure: Feasibility - Adherence to study protocol activities
timeFrame: Throughout 6 month study period
measure: Feasibility - Attrition rates
timeFrame: Throughout 6 month study period
measure: Feasibility - Adverse events
timeFrame: Throughout 6 month study period
measure: Feasibility - Participant satisfaction
timeFrame: At conclusion of 6 month study period
Secondary outcomes:
measure: Eastern Cooperative Oncology Group (ECOG) performance status
timeFrame: At 4 timepoints during the 6 month study (pre-surgery if applicable, post-surgery/prior to starting the intervention, 3 months and 6 months)
measure: Quality of life (assessed using the Functional Assessment of Cancer Therapy index)
timeFrame: At 4 timepoints during the 6 month study (pre-surgery if applicable, post-surgery/prior to starting the intervention, 3 months and 6 months)
measure: Objective physical functioning
timeFrame: At 4 timepoints during the 6 month study (pre-surgery if applicable, post-surgery/prior to starting the intervention, 3 months and 6 months)
measure: CA 19-9 (tumor markers)
timeFrame: At 4 timepoints during the 6 month study (pre-surgery if applicable, post-surgery/prior to starting the intervention, 3 months and 6 months)
measure: Completion of pancreatic cancer treatment
timeFrame: At conclusion of 6 month study
measure: Survival rates
timeFrame: At conclusion of 6 month study
measure: Pancreatic cancer recurrence rates
timeFrame: At conclusion of 6 month study
measure: Prognostic blood cytokine biomarkers
timeFrame: At 4 timepoints during the 6 month study (pre-surgery if applicable, post-surgery/prior to starting the intervention, 3 months and 6 months)
measure: Prognostic blood tumor immunity biomarkers
timeFrame: At 4 timepoints during the 6 month study (pre-surgery if applicable, post-surgery/prior to starting the intervention, 3 months and 6 months)
measure: Wearable activity monitor (weekly minutes of physical activity)
timeFrame: At 4 timepoints during the 6 month study (pre-surgery if applicable, post-surgery/prior to starting the intervention, 3 months and 6 months)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
References: