Pancreas CancerPreMobNCT03466593
Effects of Prehabilitation and Early Mobilization for Patients Undergoing Pancreas Surgery.
A study testing Prehabilitation, Routine care and Extra early mobilization in people with Pancreas Cancer, run by Göteborg University at 1 site in Sweden.
Trial summary
Open upper gastrointestinal surgery includes surgery in the upper abdomen such as ventricular, duodenal, pancreatic and biliary tract surgery. After upper abdominal surgery there is a risk of gastrointestinal and cardiopulmonary complications. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pancreas Cancer
- What is being tested?
- Prehabilitation, Routine care and Extra early mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 245 participants
- Where
- 1 siteSweden
- Study dates
- 18 Dec 2017to 31 Dec 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients scheduled to undergo pancreatic surgery
Who cannot join
- Preoperative injury or disease making it impossible to perform the intervention
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effekt av Prehabilitering Och Extra Tidig Mobilisering Efter öppen Pankreas Kirurgi
Open upper gastrointestinal surgery includes surgery in the upper abdomen such as ventricular, duodenal, pancreatic and biliary tract surgery. After upper abdominal surgery there is a risk of gastrointestinal and cardiopulmonary complications. There is currently insufficient knowledge about the effect of prehabilitation and extra early postoperative mobilization in upper pancreatic surgery.
This study's aim is to evaluate the effect of prehabilitation and extra early mobilization.
Read more
The study includes two substudies:
- A prospective cohort of 75 patients undergoing pancreatic surgery after a prehabilitation program will be compared to 75 historical controls. Primary outcome is postoperative complications.
- A randomized controlled trial based on 72 patients undergoing pancreatic studying the effect of extra early rehabilitation. The intervention group will be mobilized to bedside, standing or sitting in armchair <6 hours after surgery, ie 3-4 hours after arrival at the Postoperative Department (PIVA). The control group will be mobilized according to routine i.e. the morning after surgery. Primary outcome is PaO2.
- Conditions
- Pancreas Cancer
- Being tested
- Prehabilitation, Routine care, Extra early mobilization, Standard mobilization
- Keywords
- Prehabilitation, Recovery, Complications
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrehabilitationOther
Prehabilitation concerning eating, smoking, drinking and physical activity
Routine careOther
Preoperative information
Extra early mobilizationOther
Mobilization the day of surgery
Standard mobilizationOther
Mobilization the day after surgery
| Study group | Role | What they receive |
|---|---|---|
| Prospective cohort-prehabilitation | Experimental | A prehabilitation program including advice about diet, increased physical activity and cessation of smoking and drinking alcohol. Receives: Other: Prehabilitation |
| Retrospective cohort | Active comparator | Routine care before the prehabilitation program was introduced Receives: Other: Routine care |
| Extra early mobilization | Experimental | Mobilization the day of surgery Receives: Other: Extra early mobilization |
| Traditional mobilization | Active comparator | Routine care with mobilization the day after surgery Receives: Other: Standard mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complications
Standardized complications according to register
Measured: Whole study period from inclusion to one year after surgery
PaO2
Arterial oxygen pressure
Measured: The day before surgery to the first day after surgery
Secondary outcomes (7)
EORTC-module generic
Quality of life, EORTC-QLQ-C30 (Range 30-124) Low values correspond to high quality of life
Measured: Whole study period from inclusion to one year after surgery
EORTC-module specific for pancreas cancer
Quality of life QLQ-OG25 (Range 25- 100). Low values correspond to high quality of life
Measured: Whole study period from inclusion to one year after surgery
EORTC-module for fatigue
Quality of Life FA-R13 (range 12- 48). Low values correspond to high quality of life
Measured: Whole study period from inclusion to one year after surgery
The Postoperative Recovery Profile
Quality of recovery according to Allvin et al. 19 statements which are rated on a four grade scale fron no problem to major problem
Measured: Whole study period from inclusion to one year after surgery
Pancreatic cancer disease impact (PACADI) score
Disease specific questionnaire, 8 statements rated on a visual analogue scale from 0 (no problem) to 10 (worst imaginable problem). Sum score are used for analysis (Range 0-80)
Measured: Whole study period from inclusion to one year after surgery
Spirometry
Vital capacity
Measured: From inclusion (during preoperative information 1-14 days before surgery) to the first postoperative day after the operation
Lenght of stay
Length of stay at the hospital
Measured: From the day before surgery to discharge from the hospital (app 7-14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2018
- Study start18 Dec 2017
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
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 CancerStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1. A prospective cohort compared to historical controls 2. A randomized, controlled, intervention study.
- Masking
- None (open label)
- Enrolment
- 245 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03466593
- Sponsor's protocol ID
- FoU i VGR: 238701
- Acronym
- PreMob
- Status last verified
- Jan 2021
- First submitted
- 23 Feb 2018
- Last updated
- 5 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Fagevik Olsen M, Becovic S, Dean E. Short-term effects of mobilization on oxygenation in patients after open surgery for pancreatic cancer: a randomized controlled trial. BMC Surg. 2021 Apr 7;21(1):185. doi: 10.1186/s12893-021-01187-2.
PubMed 33827537
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effekt av Prehabilitering Och Extra Tidig Mobilisering Efter öppen Pankreas Kirurgi
- ClinicalTrials.gov ID
- NCT03466593
- Acronym / sponsor ID
- PreMob / FoU i VGR: 238701
- Conditions
- Pancreas Cancer
- Keywords
- Prehabilitation, Recovery, Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- 18 Dec 2017 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 15 Mar 2018 (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.
Open upper gastrointestinal surgery includes surgery in the upper abdomen such as ventricular, duodenal, pancreatic and biliary tract surgery. After upper abdominal surgery there is a risk of gastrointestinal and cardiopulmonary complications. There is currently insufficient knowledge about the effect of prehabilitation and extra early postoperative mobilization in upper pancreatic surgery.
This study's aim is to evaluate the effect of prehabilitation and extra early mobilization.
The study includes two substudies:
- A prospective cohort of 75 patients undergoing pancreatic surgery after a prehabilitation program will be compared to 75 historical controls. Primary outcome is postoperative complications.
- A randomized controlled trial based on 72 patients undergoing pancreatic studying the effect of extra early rehabilitation. The intervention group will be mobilized to bedside, standing or sitting in armchair <6 hours after surgery, ie 3-4 hours after arrival at the Postoperative Department (PIVA). The control group will be mobilized according to routine i.e. the morning after surgery. Primary outcome is PaO2.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 1. A prospective cohort compared to historical controls 2. A randomized, controlled, intervention study.
| Arm | Type | Receives |
|---|---|---|
| Prospective cohort-prehabilitation | Experimental | Other: PrehabilitationA prehabilitation program including advice about diet, increased physical activity and cessation of smoking and drinking alcohol. |
| Retrospective cohort | Active comparator | Other: Routine careRoutine care before the prehabilitation program was introduced |
| Extra early mobilization | Experimental | Other: Extra early mobilizationMobilization the day of surgery |
| Traditional mobilization | Active comparator | Other: Standard mobilizationRoutine care with mobilization the day after surgery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled to undergo pancreatic surgery
Key exclusion criteria (1 listed)
- Preoperative injury or disease making it impossible to perform the intervention
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 |
|---|---|---|
| PrehabilitationPrehabilitation concerning eating, smoking, drinking and physical activity | Other | Prospective cohort-prehabilitation |
| Routine carePreoperative information | Other | Retrospective cohort |
| Extra early mobilizationMobilization the day of surgery | Other | Extra early mobilization |
| Standard mobilizationMobilization the day after surgery | Other | Traditional mobilization |
Primary outcome
Postoperative complications
Time frame: Whole study period from inclusion to one year after surgery
Standardized complications according to register
PaO2
Time frame: The day before surgery to the first day after surgery
Arterial oxygen pressure
7 secondary outcomes
EORTC-module generic
Time frame: Whole study period from inclusion to one year after surgery
EORTC-module specific for pancreas cancer
Time frame: Whole study period from inclusion to one year after surgery
EORTC-module for fatigue
Time frame: Whole study period from inclusion to one year after surgery
The Postoperative Recovery Profile
Time frame: Whole study period from inclusion to one year after surgery
Pancreatic cancer disease impact (PACADI) score
Time frame: Whole study period from inclusion to one year after surgery
Spirometry
Time frame: From inclusion (during preoperative information 1-14 days before surgery) to the first postoperative day after the operation
Lenght of stay
Time frame: From the day before surgery to discharge from the hospital (app 7-14 days)
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 5 Jan 2021.
- Derived from this study: PubMed 33827537Fagevik Olsen M, Becovic S, Dean E. Short-term effects of mobilization on oxygenation in patients after open surgery for pancreatic cancer: a randomized controlled trial. BMC Surg. 2021 Apr 7;21(1):185. doi: 10.1186/s12893-021-01187-2.
- Individual participant dataSharing planned: Undecided
Related trials for Pancreas 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.
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 Prehabilitation, Routine care and Extra early mobilization in people with Pancreas Cancer, run by Göteborg University at 1 site in Sweden.
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 5 Jan 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 Sweden. 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?
Postoperative complications (time frame: Whole study period from inclusion to one year after surgery). The study lists 2 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 NCT03466593, 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 5 Jan 2021.