Pancreatic CancerMedExNCT02940067
Enhancing Fitness Before Pancreatic Surgery
A study testing MedEx in people with Pancreatic Cancer and Pancreatitis, Chronic, run by Royal Surrey County Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This is a pilot study to investigate the effect of prehabilitation on patients undergoing elective surgery for pancreatic disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Pancreatitis, Chronic
- What is being tested?
- MedEx
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Mar 2017to 20 Aug 2018
- 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
- Elective pancreatic resection
Who cannot join
- Contraindication to cardiopulmonary exercise testing: unstable cardiac disease, lower limb dysfunction Emergency surgery Ischaemic ECG during cardiopulmonary exercise test Allergy to fish oil or olive oil
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
MATTU, Royal Surrey County Hospital
Guildford, Surrey, GU2 7WG
About this study
Official title: A Multimodal Approach to Improve Fitness and Surgical Outcomes for Patients Undergoing Pancreatic Resection
This is a pilot study to investigate the effect of prehabilitation on patients undergoing elective surgery for pancreatic disease.
Read the detailed description
Pancreatic surgery is high risk. The injury associated with surgery causes a stress response, comprising a variety of hormonal and metabolic effects. Patients undergoing pancreatic surgery experience one of the largest stress responses. Prehabilitation is the process of enhancing an individual's fitness, thereby improving tolerance to an upcoming physiological stress such as surgery. Studies involving prehabilitation have been shown to improve recovery after surgery and reduce complication rates. There are currently no published reports of prehabilitation involving patients undergoing pancreatic surgery. This research study will explore the effect of prehabilitation in these patients.
Patients with pancreatic disease are some of the least fit surgical candidates due to the disease process. Exercise training can improve physical fitness before elective abdominal surgery and nutritional supplementation can also influence clinical course via different mechanisms. Patients with pancreatic disease are often malnourished for several reasons. We propose a multimodal approach to prehabilitation involving dietary and exercise interventions during a four-week period preceding elective surgery. Core data will be collected from cardiopulmonary exercise tests and blood tests (to assess insulin sensitivity), before and after prehabilitation. Secondary outcomes such as length of stay and complications will also be measured postoperatively.
- Conditions
- Pancreatic Cancer, Pancreatitis, Chronic
- Being tested
- MedEx
- Keywords
- prehabilitation, pancreatectomy, nutrition, exercise
- Medical subject headings
- Pancreatic Neoplasms, Pancreatitis, Chronic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MedExOther
Also called Prehabilitation
A combination of dietary and exercise interventions over four weeks before scheduled pancreatic surgery
| Study group | Role | What they receive |
|---|---|---|
| MedEx | Experimental | This group will receive nutritional supplementation (based on components of the MEDiterranean diet) and supervised EXercise training for four weeks - hence the trial name, MedEx. Receives: Other: MedEx |
| Standard Care | No intervention | This group will follow current standard preoperative care before scheduled pancreatic resection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak power - measured using cardiopulmonary exercise testing
cardiopulmonary fitness
Measured: Change in peak power between start and end of prehabilitation (4 weeks)
Secondary outcomes (6)
Insulin sensitivity - measured using the insulin clamp test
insulin sensitivity
Measured: Change in insulin sensitivity between start and end of prehabilitation (4 weeks)
Length of stay
Recovery
Measured: From date of operation until date of discharge
Complication rate
Morbidity
Measured: From date of operation until date of discharge
Sleep
Sleep Quality
Measured: Change in sleep quality between start and end of prehabilitation (4 weeks)
Fatigue
Fatigue Levels
Measured: Change in fatigue levels between start and end of prehabilitation (4 weeks)
Well-being
Sense of Well-being
Measured: Change in well-being scores between start and end of prehabilitation (4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2016 (estimated)
- Study start28 Mar 2017
- Primary completion21 Jun 2018
- Study completion20 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Surrey County Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Surrey
- Responsible party
- Principal investigator, Jason George, Royal Surrey County Hospital NHS Foundation Trust
- Investigators
- Tim Rockall, MD FRCS, Study chair, MATTU, Royal Surrey County Hospital, Guildford, SurreyMike Scott, FRCA FFICM, Study director, MATTU, Royal Surrey County Hospital, Guildford, SurreyJason George, MA MRCS, Principal investigator, MATTU, Royal Surrey County Hospital, Guildford, SurreyMartin Whyte, PhD FRCP, Study director, University of Surrey, Guildford, SurreyJoe Wainwright, BSc, Study director, University of Surrey and Surrey Human Performance Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02940067
- Sponsor's protocol ID
- 197169
- Acronym
- MedEx
- Status last verified
- Aug 2018
- First submitted
- 15 Oct 2016
- Last updated
- 29 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dunne DF, Jack S, Jones RP, Jones L, Lythgoe DT, Malik HZ, Poston GJ, Palmer DH, Fenwick SW. Randomized clinical trial of prehabilitation before planned liver resection. Br J Surg. 2016 Apr;103(5):504-12. doi: 10.1002/bjs.10096. Epub 2016 Feb 11.
PubMed 26864728Sato H, Carvalho G, Sato T, Lattermann R, Matsukawa T, Schricker T. The association of preoperative glycemic control, intraoperative insulin sensitivity, and outcomes after cardiac surgery. J Clin Endocrinol Metab. 2010 Sep;95(9):4338-44. doi: 10.1210/jc.2010-0135. Epub 2010 Jul 14.
PubMed 20631016Snowden CP, Prentis JM, Anderson HL, Roberts DR, Randles D, Renton M, Manas DM. Submaximal cardiopulmonary exercise testing predicts complications and hospital length of stay in patients undergoing major elective surgery. Ann Surg. 2010 Mar;251(3):535-41. doi: 10.1097/SLA.0b013e3181cf811d.
PubMed 20134313
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multimodal Approach to Improve Fitness and Surgical Outcomes for Patients Undergoing Pancreatic Resection
- ClinicalTrials.gov ID
- NCT02940067
- Acronym / sponsor ID
- MedEx / 197169
- Conditions
- Pancreatic Cancer, Pancreatitis, Chronic
- Keywords
- prehabilitation, pancreatectomy, nutrition, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Royal Surrey County Hospital NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Surrey
- Study start
- 28 Mar 2017 (actual)
- Primary completion
- 21 Jun 2018 (actual)
- Study completion
- 20 Aug 2018 (actual)
- First posted
- 20 Oct 2016 (estimated)
- 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.
This is a pilot study to investigate the effect of prehabilitation on patients undergoing elective surgery for pancreatic disease.
Detailed description
Pancreatic surgery is high risk. The injury associated with surgery causes a stress response, comprising a variety of hormonal and metabolic effects. Patients undergoing pancreatic surgery experience one of the largest stress responses. Prehabilitation is the process of enhancing an individual's fitness, thereby improving tolerance to an upcoming physiological stress such as surgery. Studies involving prehabilitation have been shown to improve recovery after surgery and reduce complication rates. There are currently no published reports of prehabilitation involving patients undergoing pancreatic surgery. This research study will explore the effect of prehabilitation in these patients.
Patients with pancreatic disease are some of the least fit surgical candidates due to the disease process. Exercise training can improve physical fitness before elective abdominal surgery and nutritional supplementation can also influence clinical course via different mechanisms. Patients with pancreatic disease are often malnourished for several reasons. We propose a multimodal approach to prehabilitation involving dietary and exercise interventions during a four-week period preceding elective surgery. Core data will be collected from cardiopulmonary exercise tests and blood tests (to assess insulin sensitivity), before and after prehabilitation. Secondary outcomes such as length of stay and complications will also be measured postoperatively.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MedEx | Experimental | Other: MedExThis group will receive nutritional supplementation (based on components of the MEDiterranean diet) and supervised EXercise training for four weeks - hence the trial name, MedEx. |
| Standard Care | No intervention | –This group will follow current standard preoperative care before scheduled pancreatic resection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elective pancreatic resection
Key exclusion criteria (1 listed)
- Contraindication to cardiopulmonary exercise testing: unstable cardiac disease, lower limb dysfunction Emergency surgery Ischaemic ECG during cardiopulmonary exercise test Allergy to fish oil or olive oil
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 |
|---|---|---|
| MedExAlso: PrehabilitationA combination of dietary and exercise interventions over four weeks before scheduled pancreatic surgery | Other | MedEx |
Primary outcome
Peak power - measured using cardiopulmonary exercise testing
Time frame: Change in peak power between start and end of prehabilitation (4 weeks)
cardiopulmonary fitness
6 secondary outcomes
Insulin sensitivity - measured using the insulin clamp test
Time frame: Change in insulin sensitivity between start and end of prehabilitation (4 weeks)
Length of stay
Time frame: From date of operation until date of discharge
Complication rate
Time frame: From date of operation until date of discharge
Sleep
Time frame: Change in sleep quality between start and end of prehabilitation (4 weeks)
Fatigue
Time frame: Change in fatigue levels between start and end of prehabilitation (4 weeks)
Well-being
Time frame: Change in well-being scores between start and end of prehabilitation (4 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 29 Aug 2018.
- Background: PubMed 26864728Dunne DF, Jack S, Jones RP, Jones L, Lythgoe DT, Malik HZ, Poston GJ, Palmer DH, Fenwick SW. Randomized clinical trial of prehabilitation before planned liver resection. Br J Surg. 2016 Apr;103(5):504-12. doi: 10.1002/bjs.10096. Epub 2016 Feb 11.
- Background: PubMed 20631016Sato H, Carvalho G, Sato T, Lattermann R, Matsukawa T, Schricker T. The association of preoperative glycemic control, intraoperative insulin sensitivity, and outcomes after cardiac surgery. J Clin Endocrinol Metab. 2010 Sep;95(9):4338-44. doi: 10.1210/jc.2010-0135. Epub 2010 Jul 14.
- Background: PubMed 20134313Snowden CP, Prentis JM, Anderson HL, Roberts DR, Randles D, Renton M, Manas DM. Submaximal cardiopulmonary exercise testing predicts complications and hospital length of stay in patients undergoing major elective surgery. Ann Surg. 2010 Mar;251(3):535-41. doi: 10.1097/SLA.0b013e3181cf811d.
- Individual participant dataSharing planned: No
Related trials for Pancreatic Cancer
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
Pancreatic Carcinoma, Pancreatic Neoplasm
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.
Tim Rockall, MD FRCS study chair
MATTU, Royal Surrey County Hospital, Guildford, Surrey
Mike Scott, FRCA FFICM study director
MATTU, Royal Surrey County Hospital, Guildford, Surrey
Jason George, MA MRCS principal investigator
MATTU, Royal Surrey County Hospital, Guildford, Surrey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MedEx in people with Pancreatic Cancer and Pancreatitis, Chronic, run by Royal Surrey County Hospital NHS Foundation Trust 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 1 inclusion and 1 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 29 Aug 2018. 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?
Peak power - measured using cardiopulmonary exercise testing (time frame: Change in peak power between start and end of prehabilitation (4 weeks)). 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 NCT02940067, which also lists 3 linked publications.
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 29 Aug 2018.