Diet and Exercise After Pancreatic Cancer

Pancreatic Cancer Clinical Trial

— PACE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03187028
• Other study ID #: F141218007
• Status: Completed
• Phase: N/A
• Start date: August 3, 2017
• Est. completion date: September 30, 2021

Study information

• Verified date: August 2021
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility - Recruitment	Number of participants excluded or not agreeing to participate	Baseline
Primary	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
Primary	Feasibility - Attrition rates	Number of participants who dropout or are withdrawn	Throughout 6 month study period
Primary	Feasibility - Adverse events	Recorded by staff	Throughout 6 month study period
Primary	Feasibility - Participant satisfaction	Survey	At conclusion of 6 month study period
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Completion of pancreatic cancer treatment	Exploratory data related to within and between group (diet and diet+exercise) differences	At conclusion of 6 month study
Secondary	Survival rates	Exploratory data related to within and between group (diet and diet+exercise) differences	At conclusion of 6 month study
Secondary	Pancreatic cancer recurrence rates	Exploratory data related to within and between group (diet and diet+exercise) differences	At conclusion of 6 month study
Secondary	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)
Secondary	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)
Secondary	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)