Pancreatic CancerPACENCT03187028
Diet and Exercise After Pancreatic Cancer
A study testing Diet Only and Diet + Exercise in people with Pancreatic Cancer, run by University of Alabama at Birmingham at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Diet Only and Diet + Exercise
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2017to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: Diet and Exercise After Pancreatic Cancer: Clinical and Functional Outcomes (Non Canonical WNT Signaling in Colorectal 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.
Read the 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.
- Conditions
- Pancreatic Cancer
- Being tested
- Diet Only, Diet + Exercise
- Keywords
- Cancer of Pancreas, Neoplasms, Pancreatic, Pancreas Cancer, Pancreas Neoplasms, Cancer of the Pancreas, Pancreatic Cancer, Foregut Cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet OnlyBehavioural
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 + ExerciseBehavioural
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 group | Role | What they receive |
|---|---|---|
| Diet only | Active comparator | 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. Receives: Behavioral: Diet Only |
| Diet + Exercise | Experimental | 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. Receives: Behavioral: Diet + Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility - Recruitment
Number of participants excluded or not agreeing to participate
Measured: Baseline
Feasibility - Adherence to study protocol activities
Feasibility measure (e.g. percent of assessments completed, percent of counseling sessions completed, etc.)
Measured: Throughout 6 month study period
Feasibility - Attrition rates
Number of participants who dropout or are withdrawn
Measured: Throughout 6 month study period
Feasibility - Adverse events
Recorded by staff
Measured: Throughout 6 month study period
Feasibility - Participant satisfaction
Survey
Measured: At conclusion of 6 month study period
Secondary outcomes (10)
Eastern Cooperative Oncology Group (ECOG) performance status
Preliminary effect size
Measured: At 4 timepoints during the 6 month study (pre-surgery if applicable, post-surgery/prior to starting the intervention, 3 months and 6 months)
Quality of life (assessed using the Functional Assessment of Cancer Therapy index)
Preliminary effect size
Measured: At 4 timepoints during the 6 month study (pre-surgery if applicable, post-surgery/prior to starting the intervention, 3 months and 6 months)
Objective physical functioning
Preliminary effect size
Measured: At 4 timepoints during the 6 month study (pre-surgery if applicable, post-surgery/prior to starting the intervention, 3 months and 6 months)
CA 19-9 (tumor markers)
Exploratory data related to within and between group (diet and diet+exercise) differences
Measured: At 4 timepoints during the 6 month study (pre-surgery if applicable, post-surgery/prior to starting the intervention, 3 months and 6 months)
Completion of pancreatic cancer treatment
Exploratory data related to within and between group (diet and diet+exercise) differences
Measured: At conclusion of 6 month study
Survival rates
Exploratory data related to within and between group (diet and diet+exercise) differences
Measured: At conclusion of 6 month study
Pancreatic cancer recurrence rates
Exploratory data related to within and between group (diet and diet+exercise) differences
Measured: At conclusion of 6 month study
Prognostic blood cytokine biomarkers
Exploratory data related to within and between group (diet and diet+exercise) differences
Measured: At 4 timepoints during the 6 month study (pre-surgery if applicable, post-surgery/prior to starting the intervention, 3 months and 6 months)
Prognostic blood tumor immunity biomarkers
Exploratory data related to within and between group (diet and diet+exercise) differences
Measured: At 4 timepoints during the 6 month study (pre-surgery if applicable, post-surgery/prior to starting the intervention, 3 months and 6 months)
Wearable activity monitor (weekly minutes of physical activity)
Exploratory data related to within and between group (diet and diet+exercise) differences
Measured: At 4 timepoints during the 6 month study (pre-surgery if applicable, post-surgery/prior to starting the intervention, 3 months and 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start3 Aug 2017
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Q. Rogers, MD, MPH, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03187028
- Sponsor's protocol ID
- F141218007
- Acronym
- PACE
- Status last verified
- Aug 2021
- First submitted
- 24 May 2017
- Last updated
- 18 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diet and Exercise After Pancreatic Cancer: Clinical and Functional Outcomes (Non Canonical WNT Signaling in Colorectal Cancer)
- ClinicalTrials.gov ID
- NCT03187028
- Acronym / sponsor ID
- PACE / F141218007
- Conditions
- Pancreatic Cancer
- Keywords
- Cancer of Pancreas, Neoplasms, Pancreatic, Pancreas Cancer, Pancreas Neoplasms, Cancer of the Pancreas, Pancreatic Cancer, Foregut Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 3 Aug 2017 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 14 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diet only | Active comparator | Behavioral: Diet OnlyDiet 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 | Experimental | Behavioral: Diet + ExerciseDiet 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diet OnlyDiet 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. | Behavioural | Diet only |
| Diet + ExerciseDiet 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. | Behavioural | Diet + Exercise |
Primary outcome
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
10 secondary outcomes
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)
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)
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)
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)
Completion of pancreatic cancer treatment
Time frame: At conclusion of 6 month study
Survival rates
Time frame: At conclusion of 6 month study
Pancreatic cancer recurrence rates
Time frame: At conclusion of 6 month study
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2021.
- Individual participant dataSharing planned: Undecided. undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet Only and Diet + Exercise in people with Pancreatic Cancer, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility - Recruitment (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2021.