- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04305067
PRECISE: Pancreatic Cancer and Exercise
February 15, 2024 updated by: Gillian Prue, Queen's University, Belfast
PRECISE: PancREatic Cancer and Individualised Supervised Exercise: a Feasibility Study
The purpose of this study is to establish the feasibility of delivering a prescribed, individualised supervised aerobic and resistance exercise programme during adjuvant therapy, to improve survival and reduce symptom burden in pancreatic cancer
Study Overview
Detailed Description
Pancreatic ductal adenocarcinoma (PDAC) is the most common malignancy of the pancreas, representing 90% of all pancreatic neoplasms.
The late presentation of symptoms and a lack of effective screening methods, means a large proportion (80-90%) are diagnosed with unresectable advanced disease, contributing to an unfavorable prognosis and dismal 5-year survival rate of ~5%.
Intensive cancer treatments (i.e.
surgery and chemotherapy) have debilitating complications including fatigue, pain and impaired physical function.
Therefore, the maintenance of physical function and quality of life are seen as primary treatment goals for pancreatic patients, particularly during adjuvant therapy.
Exercise training is emerging as an accepted component of patient care and evidence suggests regular exercise may induce an array of physiological and psychosocial benefits.
However, there is a lack of evidence on the feasibility of delivering supervised exercise interventions to individuals with resectable PDAC undergoing adjuvant therapy.
This study aims to explore the initial feasibility of delivering a supervised, individualized, and progressive concurrent exercise intervention to individuals with resectable PDAC who are undergoing adjuvant therapy, and provide data required to design a future randomized controlled trials.
Study Type
Interventional
Enrollment (Actual)
8
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Gillian Prue, PhD
- Phone Number: 02890972345
- Email: g.prue@qub.ac.uk
Study Contact Backup
- Name: Dominic O'Connor, PhD
- Phone Number: 02890975213
- Email: dominic.oconnor@qub.ac.uk
Study Locations
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Belfast, United Kingdom, BT5 5JU
- Belfast City Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- age ≥ 18 years
- histologically proven pancreatic ductal adenocarcinoma
- complete macroscopic resection (R0 or R1 resection)
- patients recovering from surgery in time for chemotherapy to be delivered with adjuvant intent
- prior malignancy active within the previous 3 years other than locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- deemed medically fit by treating team to participate in exercise programme
- able to provide informed consent.
Exclusion Criteria:
- Macroscopically remaining tumour (R2 resection or tumour node metastasis (TNM) stage IV disease)
- Pre-existing cardiac conditions; Congestive heart failure or recent serious cardiovascular event
- Chest pain while undertaking physical activity
- Any related co-morbidities (diabetes; unstable angina; degenerative neuromuscular disease; mental health disorders; substance abuse)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Supervised aerobic and resistance exercise
16 weeks of supervised, moderate intensity, aerobic and resistance exercise.
Aerobic exercise will be completed supervised, 2 days per week, commencing with a single 10 minute bout and progressing to 30 minutes of continuous aerobic exercise.
Resistance exercises will involve whole body activities and commence with 1 set of each exercise (6-12 repetitions) and progress to 3 sets.
The resistance exercises will gradually progress in difficulty throughout the program and will utilise daily undulating periodisation
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Exercise programs will be individually tailored to the capabilities of each participant and gradually progressed accordingly.
Each patient will be asked to complete one home-based aerobic exercise sessions each week.
At baseline, 16 weeks and 3 month followup patients will complete a physical fitness assessment (30 second sit to stand and six minute walking tests) and a range of quality of life questionnaires.
Upon completion of the 16 week exercise intervention, patients will be invited to partake in semi-structured interviews to determine the effectiveness of the program and their experience throughout.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility - recruitment: number of participants that agree to participate or are excluded
Time Frame: At baseline
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The number of participants that agree to participate or are excluded
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At baseline
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Feasibility - attrition: number of participants that withdraw from the study
Time Frame: At conclusion of the 16 week exercise intervention
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The number of participants that withdraw from the study
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At conclusion of the 16 week exercise intervention
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Feasibility - adherence to the exercise intervention: percentage of participants adhering to the exercise intervention
Time Frame: At conclusion of the 16 week exercise intervention
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Determine the percentage of participants adhering to the exercise intervention
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At conclusion of the 16 week exercise intervention
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Feasibility - participant experience: semi-structured interviews
Time Frame: At conclusion of the 16 week exercise intervention
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Determined by qualitative evaluation, using semi-structured interviews to assess experiences, accessibility and acceptability of the exercise intervention
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At conclusion of the 16 week exercise intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anthropometric assessment
Time Frame: At baseline, 16 weeks, 3 month follow-up
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Height will be measured in cm and body weight in k, which will be combined to report BMI in kg/m (squared).
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At baseline, 16 weeks, 3 month follow-up
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Hip and waist circumference analysis
Time Frame: At baseline, 16 weeks, 3 month follow-up
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Hip and waist circumference will be measured in cm.
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At baseline, 16 weeks, 3 month follow-up
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Functional muscle endurance assessment
Time Frame: At baseline, 16 weeks, 3 month follow-up
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The amount of repetitions achieved during a 30 second sit-to-stand test will be recorded.
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At baseline, 16 weeks, 3 month follow-up
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Physical fitness assessment
Time Frame: At baseline, 16 weeks, 3 month follow-up
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Distance covered in meters during a six minute walk test will be recorded.
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At baseline, 16 weeks, 3 month follow-up
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Perceived physical activity levels
Time Frame: At baseline, 16 weeks, 3 month follow-up
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Patients will complete an International Physical Activity Questionnaire (IPAQ-SF).
This questionnaire will comprise 4 generic items to obtain comparable health-related physical activity.
Patients will detail the number of days, hours and minutes that they undertake (1) vigorous exercise (2) moderate exercise (3) walking exercise and (4) sitting.
Total physical activity will be generated and monitored for improvement or decline.
Higher reported scores indicate higher levels of self-reported physical activity.
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At baseline, 16 weeks, 3 month follow-up
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Cancer-related fatigue by questionnaire
Time Frame: At baseline, 16 weeks, 3 month follow-up
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Fatigue will be measured by the Functional Assessment of Cancer Therapy - Fatigue (FACIT-Fatigue) questionnaire.
Patients will score several fatigue items over the past 7 days on a scale (0 = not at all; 4 = very much), generating a total (0 - 52) with higher scores linked to greater quality of life.
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At baseline, 16 weeks, 3 month follow-up
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Patient rated pain by questionnaire
Time Frame: At baseline, 16 weeks, 3 month follow-up
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Pain will be measured using the Brief Pain Inventory (BPI).
Pain is scored on a scale 0 - 10, with higher scores indicating higher pain levels.
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At baseline, 16 weeks, 3 month follow-up
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Well-being by questionnaire
Time Frame: At baseline, 16 weeks, 3 month follow-up
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Quality of life will be measured by the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) questionnaire.
This questionnaire is scored on a scale of 0 - 4, with 0 indicating not at all, and 4 indicating very much.
Higher scores indicate poorer quality of life.
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At baseline, 16 weeks, 3 month follow-up
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Health related quality of life by questionnaire
Time Frame: At baseline, 16 weeks, 3 month follow-up
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Quality of life will be measured by the EuroQOL Five Dimension Questionnaire (EQ5D).
Patients will select a level of difficulty (I have no - I have extreme) on that particular days health for mobility, self-care, usual activities, pain / discomfort and anxiety / depression.
Patients will then rate 'how good' or 'how bad' their health is on that day using a 100 point scale (0 = worst health you can imagine; 100 = best health you can imagine).
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At baseline, 16 weeks, 3 month follow-up
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Health economics
Time Frame: At 16 weeks
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Health resource use will be evaluated by a Health Economics Questionnaire
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At 16 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Richard Turkington, MD, Queens University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2020
Primary Completion (Actual)
July 31, 2022
Study Completion (Actual)
August 1, 2022
Study Registration Dates
First Submitted
February 28, 2020
First Submitted That Met QC Criteria
March 9, 2020
First Posted (Actual)
March 12, 2020
Study Record Updates
Last Update Posted (Actual)
February 16, 2024
Last Update Submitted That Met QC Criteria
February 15, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- B19/35
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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