Pancreas AdenocarcinomaNCT04305067
PRECISE: Pancreatic Cancer and Exercise
A study testing Exercise in people with Pancreas Adenocarcinoma, run by Queen's University, Belfast at 1 site in United Kingdom.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Adenocarcinoma
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Aug 2020to 1 Aug 2022
- 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
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Pancreas Adenocarcinoma
- Being tested
- Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Supervised aerobic and resistance exercise | Experimental | 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 Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility - recruitment: number of participants that agree to participate or are excluded
The number of participants that agree to participate or are excluded
Measured: At baseline
Feasibility - attrition: number of participants that withdraw from the study
The number of participants that withdraw from the study
Measured: At conclusion of the 16 week exercise intervention
Feasibility - adherence to the exercise intervention: percentage of participants adhering to the exercise intervention
Determine the percentage of participants adhering to the exercise intervention
Measured: At conclusion of the 16 week exercise intervention
Feasibility - participant experience: semi-structured interviews
Determined by qualitative evaluation, using semi-structured interviews to assess experiences, accessibility and acceptability of the exercise intervention
Measured: At conclusion of the 16 week exercise intervention
Secondary outcomes (10)
Anthropometric assessment
Height will be measured in cm and body weight in k, which will be combined to report BMI in kg/m (squared).
Measured: At baseline, 16 weeks, 3 month follow-up
Hip and waist circumference analysis
Hip and waist circumference will be measured in cm.
Measured: At baseline, 16 weeks, 3 month follow-up
Functional muscle endurance assessment
The amount of repetitions achieved during a 30 second sit-to-stand test will be recorded.
Measured: At baseline, 16 weeks, 3 month follow-up
Physical fitness assessment
Distance covered in meters during a six minute walk test will be recorded.
Measured: At baseline, 16 weeks, 3 month follow-up
Perceived physical activity levels
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.
Measured: At baseline, 16 weeks, 3 month follow-up
Cancer-related fatigue by questionnaire
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.
Measured: At baseline, 16 weeks, 3 month follow-up
Patient rated pain by questionnaire
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.
Measured: At baseline, 16 weeks, 3 month follow-up
Well-being by questionnaire
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.
Measured: At baseline, 16 weeks, 3 month follow-up
Health related quality of life by questionnaire
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).
Measured: At baseline, 16 weeks, 3 month follow-up
Health economics
Health resource use will be evaluated by a Health Economics Questionnaire
Measured: At 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2020
- Study start1 Aug 2020
- Primary completion31 Jul 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreas AdenocarcinomaStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University, Belfast
- Sponsor type
- University, hospital or other
- Collaborators
- Pancreatic Cancer UK, Belfast Health and Social Care Trust
- Responsible party
- Principal investigator, Gillian Prue, Queen's University, Belfast
- Investigators
- Richard Turkington, MD, Principal investigator, Queens University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04305067
- Sponsor's protocol ID
- B19/35
- Status last verified
- Feb 2024
- First submitted
- 28 Feb 2020
- Last updated
- 16 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brown M, O'Connor D, Turkington R, Eatock M, Vince R, Hulme C, Bowdery R, Robinson R, Wadsley J, Maraveyas A, Prue G. Feasibility of delivering supervised exercise training following surgical resection and during adjuvant chemotherapy for pancreatic ductal adenocarcinoma (PRECISE): a case series. BMC Sports Sci Med Rehabil. 2023 Sep 21;15(1):116. doi: 10.1186/s13102-023-00722-3.
PubMed 37735664
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRECISE: PancREatic Cancer and Individualised Supervised Exercise: a Feasibility Study
- ClinicalTrials.gov ID
- NCT04305067
- Acronym / sponsor ID
- B19/35
- Conditions
- Pancreas Adenocarcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Queen's University, BelfastUniversity, hospital or other
- Collaborators
- Pancreatic Cancer UK, Belfast Health and Social Care Trust
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 12 Mar 2020 (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.
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
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supervised aerobic and resistance exercise | Experimental | Other: Exercise16 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
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 |
|---|---|---|
| ExerciseExercise 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. | Other | Supervised aerobic and resistance exercise |
Primary outcome
Feasibility - recruitment: number of participants that agree to participate or are excluded
Time frame: At baseline
The number of participants that agree to participate or are excluded
Feasibility - attrition: number of participants that withdraw from the study
Time frame: At conclusion of the 16 week exercise intervention
The number of participants that withdraw from the study
Feasibility - adherence to the exercise intervention: percentage of participants adhering to the exercise intervention
Time frame: At conclusion of the 16 week exercise intervention
Determine the percentage of participants adhering to the exercise intervention
Feasibility - participant experience: semi-structured interviews
Time frame: At conclusion of the 16 week exercise intervention
Determined by qualitative evaluation, using semi-structured interviews to assess experiences, accessibility and acceptability of the exercise intervention
10 secondary outcomes
Anthropometric assessment
Time frame: At baseline, 16 weeks, 3 month follow-up
Hip and waist circumference analysis
Time frame: At baseline, 16 weeks, 3 month follow-up
Functional muscle endurance assessment
Time frame: At baseline, 16 weeks, 3 month follow-up
Physical fitness assessment
Time frame: At baseline, 16 weeks, 3 month follow-up
Perceived physical activity levels
Time frame: At baseline, 16 weeks, 3 month follow-up
Cancer-related fatigue by questionnaire
Time frame: At baseline, 16 weeks, 3 month follow-up
Patient rated pain by questionnaire
Time frame: At baseline, 16 weeks, 3 month follow-up
Well-being by questionnaire
Time frame: At baseline, 16 weeks, 3 month follow-up
Health related quality of life by questionnaire
Time frame: At baseline, 16 weeks, 3 month follow-up
Health economics
Time frame: At 16 weeks
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 16 Feb 2024.
- Derived from this study: PubMed 37735664Brown M, O'Connor D, Turkington R, Eatock M, Vince R, Hulme C, Bowdery R, Robinson R, Wadsley J, Maraveyas A, Prue G. Feasibility of delivering supervised exercise training following surgical resection and during adjuvant chemotherapy for pancreatic ductal adenocarcinoma (PRECISE): a case series. BMC Sports Sci Med Rehabil. 2023 Sep 21;15(1):116. doi: 10.1186/s13102-023-00722-3.
- Individual participant dataSharing planned: No
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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.
Richard Turkington, MD principal investigator
Queens University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Pancreas Adenocarcinoma, run by Queen's University, Belfast at 1 site in United Kingdom.
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 8 inclusion and 4 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 16 Feb 2024. 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 Kingdom. 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: number of participants that agree to participate or are excluded (time frame: At baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04305067, which also lists 1 linked publication.
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 16 Feb 2024.