Surgery--ComplicationsPRIONCT04199208
Does Prehabilitation Improve Outcome in Coloncancer Surgery?
A study testing Prehabilitation and Immunonutrition in people with Surgery--Complications, run by Region Skane.
Trial summary
The study aims to find out if complications after surgery for large bowel (colon) cancer can be reduced or avoided in the most frail and elderly by letting them go through an exercise- and diet regime prior to the surgical procedure. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Surgery--Complications
- What is being tested?
- Prehabilitation and Immunonutrition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2020to 7 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 60 years of older
- Colon cancer diagnosis (macroscopic, microscopic or x-ray diagnosed)
- Ventilatory Anaerobic Threshold <11mg/ml/kg
- Planned open or laparoscopic colectomy due to colon cancer
Who cannot join
- Lower extremity amputee
- Disease requiring radio- and/or chemotherapy prior to surgery/palliative disease
- Distal metastases (Locoregional lymph nodes are OK)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Prehabilitation on Surgical Complications Following Colon Surgery - a Prospective Randomized Study
The study aims to find out if complications after surgery for large bowel (colon) cancer can be reduced or avoided in the most frail and elderly by letting them go through an exercise- and diet regime prior to the surgical procedure.
Read the detailed description
All patients with colon cancer who are intended for curative surgery without neoadjuvant chemotherapy who are >=60 years old will be screened with an ergospirometry. The ones that have a ventilate anaerobic threshold (VAT) of less than 11 mg/ml/kg will be included in the study as they are considered extra frail and have a previously proven high risk for complications. These patients will be randomized to standard care or an intervention of prehabilitation consisting of immunonutrition (protein supplement, multivitamin supplement, Selene etc) and an exercise regimen with 4x1 hours per week of cycling on an ergometer. The exercise regimen will be performed in a group of patients and will be led by a physical therapist to ensure compliance. The resistance of the ergometer will be standardized according to the patient's VAT.
The primary outcome measures will be number of and severity of postoperative complications. Secondary outcome measures include quality of life during prehabilitation with repeated measurements during 5 years after surgery, disease-free survival and overall survival.
- Conditions
- Surgery--Complications
- Being tested
- Prehabilitation and Immunonutrition, Standard Care Arm
- Keywords
- exercise therapy, perioperative period, coloncancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prehabilitation and ImmunonutritionOther
See study synopsis
Standard Care ArmOther
Standard care as per the daily routines of the Hospital at which the study takes place
| Study group | Role | What they receive |
|---|---|---|
| Standard Care Arm | Active comparator | Standard perioperative care is given. Receives: Other: Standard Care Arm |
| Interventional Arm | Experimental | Intervention of prehabilitation and immunonutrition is given prior to surgery Receives: Other: Prehabilitation and Immunonutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications
Severity of postoperative complications according do Clavien-Dindo
Measured: Assessed when patient is discharged from hospital
Complications
Number of complication(s) according to POMS
Measured: Assessed at postoperative day 5.
Secondary outcomes (3)
Quality of life with SF-36
Quality of life
Measured: At point in time when patient is informed of the cancer, after prehabilitation (just before surgery), 30 days, 2, 3 and 6 months, 1, 3 and 5 years after surgery.
Disease-free survival
Cancer-free survival Cancer-free survival of the group of the group
Measured: 30 and 90 days after surgery, 1, 3 and 5 years after surgery.
Overall survival
Overall survival of the group (taking all causes of death into account)
Measured: 30 and 90 days after surgery, 1, 3 and 5 years after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start1 Oct 2020 (estimated)
- Primary completion7 Jan 2023 (estimated)
- Study completion7 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgery--ComplicationsStudies of the same condition, open and under way.
- More trials run by Region SkaneThe 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
- Randomized two-armed clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefan Öberg, MD, PhD, Principal investigator, Region Skåne/Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04199208
- Sponsor's protocol ID
- PRIO01
- Acronym
- PRIO
- Status last verified
- Apr 2020
- First submitted
- 9 Dec 2019
- Last updated
- 9 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Prehabilitation on Surgical Complications Following Colon Surgery - a Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT04199208
- Acronym / sponsor ID
- PRIO / PRIO01
- Conditions
- Surgery--Complications
- Keywords
- exercise therapy, perioperative period, coloncancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 7 Jan 2023 (estimated)
- Study completion
- 7 Jan 2028 (estimated)
- First posted
- 13 Dec 2019 (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 study aims to find out if complications after surgery for large bowel (colon) cancer can be reduced or avoided in the most frail and elderly by letting them go through an exercise- and diet regime prior to the surgical procedure.
Detailed description
All patients with colon cancer who are intended for curative surgery without neoadjuvant chemotherapy who are >=60 years old will be screened with an ergospirometry. The ones that have a ventilate anaerobic threshold (VAT) of less than 11 mg/ml/kg will be included in the study as they are considered extra frail and have a previously proven high risk for complications. These patients will be randomized to standard care or an intervention of prehabilitation consisting of immunonutrition (protein supplement, multivitamin supplement, Selene etc) and an exercise regimen with 4x1 hours per week of cycling on an ergometer. The exercise regimen will be performed in a group of patients and will be led by a physical therapist to ensure compliance. The resistance of the ergometer will be standardized according to the patient's VAT.
The primary outcome measures will be number of and severity of postoperative complications. Secondary outcome measures include quality of life during prehabilitation with repeated measurements during 5 years after surgery, disease-free survival and overall survival.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized two-armed clinical trial
| Arm | Type | Receives |
|---|---|---|
| Standard Care Arm | Active comparator | Other: Standard Care ArmStandard perioperative care is given. |
| Interventional Arm | Experimental | Other: Prehabilitation and ImmunonutritionIntervention of prehabilitation and immunonutrition is given prior to surgery |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 60 years of older
- Colon cancer diagnosis (macroscopic, microscopic or x-ray diagnosed)
- Ventilatory Anaerobic Threshold <11mg/ml/kg
- Planned open or laparoscopic colectomy due to colon cancer
Key exclusion criteria (3 listed)
- Lower extremity amputee
- Disease requiring radio- and/or chemotherapy prior to surgery/palliative disease
- Distal metastases (Locoregional lymph nodes are OK)
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 |
|---|---|---|
| Prehabilitation and ImmunonutritionSee study synopsis | Other | Interventional Arm |
| Standard Care ArmStandard care as per the daily routines of the Hospital at which the study takes place | Other | Standard Care Arm |
Primary outcome
Complications
Time frame: Assessed when patient is discharged from hospital
Severity of postoperative complications according do Clavien-Dindo
Complications
Time frame: Assessed at postoperative day 5.
Number of complication(s) according to POMS
3 secondary outcomes
Quality of life with SF-36
Time frame: At point in time when patient is informed of the cancer, after prehabilitation (just before surgery), 30 days, 2, 3 and 6 months, 1, 3 and 5 years after surgery.
Disease-free survival
Time frame: 30 and 90 days after surgery, 1, 3 and 5 years after surgery.
Overall survival
Time frame: 30 and 90 days after surgery, 1, 3 and 5 years after surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2020.
- 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.
Stefan Öberg, MD, PhD principal investigator
Region Skåne/Lund University
Questions about this trial
What is this clinical trial studying?
A study testing Prehabilitation and Immunonutrition in people with Surgery--Complications, run by Region Skane.
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 4 inclusion and 3 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: opening soon, as of the sponsor's last update on 9 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stefan Öberg, MD, PhD (+46424061000, stefan.oberg@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complications (time frame: Assessed when patient is discharged from hospital). 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?
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 9 Apr 2020.