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Diet and Exercise After Pancreatic Cancer (PACE)

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ClinicalTrials.gov Identifier: NCT03187028
Recruitment Status : Recruiting
First Posted : June 14, 2017
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
Laura Q. Rogers, MD, MPH, University of Alabama at Birmingham

Tracking Information
First Submitted Date  ICMJE May 24, 2017
First Posted Date  ICMJE June 14, 2017
Last Update Posted Date August 6, 2019
Actual Study Start Date  ICMJE August 3, 2017
Estimated Primary Completion Date April 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 13, 2017)
  • Feasibility - Recruitment [ Time Frame: Baseline ]
    Number of participants excluded or not agreeing to participate
  • 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.)
  • Feasibility - Attrition rates [ Time Frame: Throughout 6 month study period ]
    Number of participants who dropout or are withdrawn
  • Feasibility - Adverse events [ Time Frame: Throughout 6 month study period ]
    Recorded by staff
  • Feasibility - Participant satisfaction [ Time Frame: At conclusion of 6 month study period ]
    Survey
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03187028 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 29, 2017)
  • 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
  • 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
  • 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
  • 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
  • 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
  • Survival rates [ Time Frame: At conclusion of 6 month study ]
    Exploratory data related to within and between group (diet and diet+exercise) differences
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: June 13, 2017)
  • Eastern Cooperative Oncology Group (ECOG) performance status [ Time Frame: At 4 timepoints during the 6 month study (baseline (pre-surgery), within 4 weeks post-surgery, 3 months and 6 months) ]
    Preliminary effect size
  • Quality of life (assessed using the Functional Assessment of Cancer Therapy index) [ Time Frame: At 4 timepoints during the 6 month study (baseline (pre-surgery), within 4 weeks post-surgery, 3 months and 6 months) ]
    Preliminary effect size
  • Objective physical functioning [ Time Frame: At 4 timepoints during the 6 month study (baseline (pre-surgery), within 4 weeks post-surgery, 3 months and 6 months) ]
    Preliminary effect size
  • CA 19-9 (tumor markers) [ Time Frame: At 4 timepoints during the 6 month study (baseline (pre-surgery), within 4 weeks post-surgery, 3 months and 6 months) ]
    Exploratory data related to within and between group (diet and diet+exercise) differences
  • 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
  • Survival rates [ Time Frame: At conclusion of 6 month study ]
    Exploratory data related to within and between group (diet and diet+exercise) differences
  • 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
  • Prognostic blood cytokine biomarkers [ Time Frame: At 4 timepoints during the 6 month study (baseline (pre-surgery), within 4 weeks post-surgery, 3 months and 6 months) ]
    Exploratory data related to within and between group (diet and diet+exercise) differences
  • Prognostic blood tumor immunity biomarkers [ Time Frame: At 4 timepoints during the 6 month study (baseline (pre-surgery), within 4 weeks post-surgery, 3 months and 6 months) ]
    Exploratory data related to within and between group (diet and diet+exercise) differences
  • Wearable activity monitor (weekly minutes of physical activity) [ Time Frame: At 4 timepoints during the 6 month study (baseline (pre-surgery), within 4 weeks post-surgery, 3 months and 6 months) ]
    Exploratory data related to within and between group (diet and diet+exercise) differences
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Diet and Exercise After Pancreatic Cancer
Official Title  ICMJE Diet and Exercise After Pancreatic Cancer: Clinical and Functional Outcomes (Non Canonical WNT Signaling in Colorectal Cancer)
Brief Summary Determine feasibility of a randomized controlled trial (RCT) in pancreatic cancer patients comparing the effects of diet alone vs. diet+exercise on functional and clinical outcomes.
Detailed Description Pancreatic cancer causes 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 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 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Pancreatic Cancer
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Diet Only
  • 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.
    Intervention: Behavioral: Diet + Exercise
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 13, 2017)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 31, 2021
Estimated Primary Completion Date April 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • adult 18 years of age or older with resectable pancreatic adenocarcinoma 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:

  • pancreatic 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Laura Q Rogers, MD, MPH 205-975-1667 rogersl@uab.edu
Contact: David Bryan, MS 205-975-1247 dbryan@uab.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03187028
Other Study ID Numbers  ICMJE F141218007
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: undecided
Responsible Party Laura Q. Rogers, MD, MPH, University of Alabama at Birmingham
Study Sponsor  ICMJE University of Alabama at Birmingham
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Alabama at Birmingham
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP