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Diet and Exercise After Pancreatic Cancer (PACE)

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ClinicalTrials.gov Identifier: NCT03187028
Recruitment Status : Completed
First Posted : June 14, 2017
Last Update Posted : November 18, 2021
Sponsor:
Information provided by (Responsible Party):
Laura Q. Rogers, MD, MPH, University of Alabama at Birmingham

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Behavioral: Diet Only Behavioral: Diet + Exercise Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Diet and Exercise After Pancreatic Cancer: Clinical and Functional Outcomes (Non Canonical WNT Signaling in Colorectal Cancer)
Actual Study Start Date : August 3, 2017
Actual Primary Completion Date : September 30, 2021
Actual Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Feasibility - Recruitment [ Time Frame: Baseline ]
    Number of participants excluded or not agreeing to participate

  2. Feasibility - Adherence to study protocol activities [ Time Frame: Throughout 6 month study period ]
    Feasibility measure (e.g. percent of assessments completed, percent of counseling sessions completed, etc.)

  3. Feasibility - Attrition rates [ Time Frame: Throughout 6 month study period ]
    Number of participants who dropout or are withdrawn

  4. Feasibility - Adverse events [ Time Frame: Throughout 6 month study period ]
    Recorded by staff

  5. Feasibility - Participant satisfaction [ Time Frame: At conclusion of 6 month study period ]
    Survey


Secondary Outcome Measures :
  1. Eastern Cooperative Oncology Group (ECOG) performance status [ 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) ]
    Preliminary effect size

  2. Quality of life (assessed using the Functional Assessment of Cancer Therapy index) [ 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) ]
    Preliminary effect size

  3. Objective physical functioning [ 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) ]
    Preliminary effect size

  4. CA 19-9 (tumor markers) [ 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) ]
    Exploratory data related to within and between group (diet and diet+exercise) differences

  5. Completion of pancreatic cancer treatment [ Time Frame: At conclusion of 6 month study ]
    Exploratory data related to within and between group (diet and diet+exercise) differences

  6. Survival rates [ Time Frame: At conclusion of 6 month study ]
    Exploratory data related to within and between group (diet and diet+exercise) differences

  7. Pancreatic cancer recurrence rates [ Time Frame: At conclusion of 6 month study ]
    Exploratory data related to within and between group (diet and diet+exercise) differences

  8. Prognostic blood cytokine biomarkers [ 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) ]
    Exploratory data related to within and between group (diet and diet+exercise) differences

  9. Prognostic blood tumor immunity biomarkers [ 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) ]
    Exploratory data related to within and between group (diet and diet+exercise) differences

  10. Wearable activity monitor (weekly minutes of physical activity) [ 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) ]
    Exploratory data related to within and between group (diet and diet+exercise) differences


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03187028


Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
More Information
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Responsible Party: Laura Q. Rogers, MD, MPH, Primary Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03187028    
Other Study ID Numbers: F141218007
First Posted: June 14, 2017    Key Record Dates
Last Update Posted: November 18, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Laura Q. Rogers, MD, MPH, University of Alabama at Birmingham:
Cancer of Pancreas
Neoplasms, Pancreatic
Pancreas Cancer
Pancreas Neoplasms
 Cancer of the Pancreas
Pancreatic Cancer
Foregut Cancer
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases