Diet and Exercise After Pancreatic Cancer (PACE)

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

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.

Study Overview

• Status: Completed
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Behavioral: Diet Only; Behavioral: Diet + Exercise

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Diet only; 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; 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.
EXPERIMENTAL: Diet + Exercise; 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; 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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 3, 2017
• Primary Completion (ACTUAL): September 30, 2021
• Study Completion (ACTUAL): September 30, 2021

Study Registration Dates

• First Submitted: May 24, 2017
• First Submitted That Met QC Criteria: June 13, 2017
• First Posted (ACTUAL): June 14, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 18, 2021
• Last Update Submitted That Met QC Criteria: November 16, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Pancreatic Cancer; Pancreas Cancer; Pancreas Neoplasms; Cancer of Pancreas; Neoplasms, Pancreatic; Cancer of the Pancreas; Foregut Cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: F141218007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No