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Diet and Exercise After Pancreatic Cancer (PACE)

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diet Only
Diet + Exercise
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pancreatic Cancer focused on measuring Cancer of Pancreas, Neoplasms, Pancreatic, Pancreas Cancer, Pancreas Neoplasms, Cancer of the Pancreas, Pancreatic Cancer, Foregut Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Diet only

Diet + Exercise

Arm Description

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 also receiving a fitness bracelet to facilitate counseling by the certified Cancer Exercise Trainer.

Outcomes

Primary Outcome Measures

Feasibility - Recruitment
Number of participants excluded or not agreeing to participate
Feasibility - Adherence to study protocol activities
Feasibility measure (e.g. percent of assessments completed, percent of counseling sessions completed, etc.)
Feasibility - Attrition rates
Number of participants who dropout or are withdrawn
Feasibility - Adverse events
Recorded by staff
Feasibility - Participant satisfaction
Survey

Secondary Outcome Measures

Eastern Cooperative Oncology Group (ECOG) performance status
Preliminary effect size
Quality of life (assessed using the Functional Assessment of Cancer Therapy index)
Preliminary effect size
Objective physical functioning
Preliminary effect size
CA 19-9 (tumor markers)
Exploratory data related to within and between group (diet and diet+exercise) differences
Completion of pancreatic cancer treatment
Exploratory data related to within and between group (diet and diet+exercise) differences
Survival rates
Exploratory data related to within and between group (diet and diet+exercise) differences
Pancreatic cancer recurrence rates
Exploratory data related to within and between group (diet and diet+exercise) differences
Prognostic blood cytokine biomarkers
Exploratory data related to within and between group (diet and diet+exercise) differences
Prognostic blood tumor immunity biomarkers
Exploratory data related to within and between group (diet and diet+exercise) differences
Wearable activity monitor (weekly minutes of physical activity)
Exploratory data related to within and between group (diet and diet+exercise) differences

Full Information

First Posted
May 24, 2017
Last Updated
November 16, 2021
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT03187028
Brief Title
Diet and Exercise After Pancreatic Cancer
Acronym
PACE
Official Title
Diet and Exercise After Pancreatic Cancer: Clinical and Functional Outcomes (Non Canonical WNT Signaling in Colorectal Cancer)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
August 3, 2017 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
Cancer of Pancreas, Neoplasms, Pancreatic, Pancreas Cancer, Pancreas Neoplasms, Cancer of the Pancreas, Pancreatic Cancer, Foregut Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diet only
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Diet + Exercise
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Diet Only
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Diet + Exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility - Recruitment
Description
Number of participants excluded or not agreeing to participate
Time Frame
Baseline
Title
Feasibility - Adherence to study protocol activities
Description
Feasibility measure (e.g. percent of assessments completed, percent of counseling sessions completed, etc.)
Time Frame
Throughout 6 month study period
Title
Feasibility - Attrition rates
Description
Number of participants who dropout or are withdrawn
Time Frame
Throughout 6 month study period
Title
Feasibility - Adverse events
Description
Recorded by staff
Time Frame
Throughout 6 month study period
Title
Feasibility - Participant satisfaction
Description
Survey
Time Frame
At conclusion of 6 month study period
Secondary Outcome Measure Information:
Title
Eastern Cooperative Oncology Group (ECOG) performance status
Description
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)
Title
Quality of life (assessed using the Functional Assessment of Cancer Therapy index)
Description
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)
Title
Objective physical functioning
Description
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)
Title
CA 19-9 (tumor markers)
Description
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)
Title
Completion of pancreatic cancer treatment
Description
Exploratory data related to within and between group (diet and diet+exercise) differences
Time Frame
At conclusion of 6 month study
Title
Survival rates
Description
Exploratory data related to within and between group (diet and diet+exercise) differences
Time Frame
At conclusion of 6 month study
Title
Pancreatic cancer recurrence rates
Description
Exploratory data related to within and between group (diet and diet+exercise) differences
Time Frame
At conclusion of 6 month study
Title
Prognostic blood cytokine biomarkers
Description
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)
Title
Prognostic blood tumor immunity biomarkers
Description
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)
Title
Wearable activity monitor (weekly minutes of physical activity)
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
undecided

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Diet and Exercise After Pancreatic Cancer

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