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Completed

NCT Number: NCT03187028

Diet and Exercise After Pancreatic 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diet only

Behavioral

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 + Exercise

Behavioral

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

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

Acronym: PACE

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Jun 14, 2017
Registry last updated
Nov 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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