Colorectal NeoplasmsNCT02502760
Using Multimodal Prehabilitation to Improve Outcomes for Frail Patients Undergoing Resection of Colorectal Cancer
A study testing Physical Exercise Program, Whey Protein Isolate Powder and Relaxation Techniques in people with Colorectal Neoplasms, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 2 sites in Canada.
Trial summary
The purpose of this study is to determine if a program of physical activity, nutritional supplements and relaxation techniques is effective at decreasing post operative complications in frail colorectal cancer patients undergoing resection. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- Physical Exercise Program, Whey Protein Isolate Powder and Relaxation Techniques
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesCanada
- Study dates
- Aug 2015to 19 Jun 2019
- 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
- Colorectal cancer patient undergoing resection
- Frail or intermediately frail patients (Fried score 2 and above)
Who cannot join
- Unable to communicate in French or English
- Premorbid conditions contraindicating physical exercise (dementia, Parkinson Disease, previous stroke with paresis, taking carbidopa/levodopa, donepezil or antidepressants)
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
McGill University Health Center; Montreal General Hospital
Montreal, Quebec, H3G 1A4
Sir Mortimer B. Davis - Jewish General Hospital
Montreal, Quebec, H3T1E2
About this study
The purpose of this study is to determine if a program of physical activity, nutritional supplements and relaxation techniques is effective at decreasing post operative complications in frail colorectal cancer patients undergoing resection.
- Conditions
- Colorectal Neoplasms
- Being tested
- Physical Exercise Program, Whey Protein Isolate Powder, Relaxation Techniques
- Keywords
- Postoperative Complications, Perioperative Care, Colorectal Surgery, Frail Elderly
- Medical subject headings
- Colorectal Neoplasms, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Exercise ProgramBehavioural
Physical exercises personalized by a kinesiologist consisting of walking or stationary bike and elastic band exercises.
Whey Protein Isolate PowderDietary supplement
Nutritional counselling is given to patients to ensure their daily proteins and energy requirements are met. Whey Protein Isolate Powder (Immunocal) is provided.
Immunocal1.5g/kg PO (by mouth) per day separated in 2 daily doses
Relaxation TechniquesBehavioural
Relaxation techniques consisting of breathing exercises and using a relaxation CD.
| Study group | Role | What they receive |
|---|---|---|
| Prehabilitation | Experimental | Immediately after randomization and until surgery, patients in this arm will:
1. - Receive a personalized physical exercise program
2. - Receive nutritional counselling with Whey protein isolate powder
3. - Receive relaxation techniques Receives: Behavioral: Physical Exercise Program; Dietary Supplement: Whey Protein Isolate Powder; Behavioral: Relaxation Techniques |
| Rehabilitation | Active comparator | Patients in this arm will receive the same personalized physical exercise program, nutritional intervention and relaxation techniques as patients in the other arm but to be started after surgery. Receives: Behavioral: Physical Exercise Program; Dietary Supplement: Whey Protein Isolate Powder; Behavioral: Relaxation Techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative complications
Comprehensive Complication Index (CCI)
Measured: 30 days after surgery
Secondary outcomes (5)
6 Minutes Walk Test Distance
Measured: 4 weeks after discharge
Hospital Length of Stay
Measured: 3-6 days
Readmission rates
Measured: 30 days after discharge
Anxiety and Depression
Using the Hospital Anxiety Depression Scale (HADS)
Measured: 30 days after discharge
Health Related Quality of Life
Using the Short Form Health Survey (SF-36)
Measured: 30 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2015 (estimated)
- Study startAug 2015
- Primary completion19 Jun 2019
- Study completion19 Jun 2019
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 Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Sir Mortimer B. Davis - Jewish General Hospital
- Responsible party
- Principal investigator, Franco Carli, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Franco Carli, MD, MPhil, Principal investigator, Professor, Department of Anesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02502760
- Sponsor's protocol ID
- 15-131-MUHC
- Status last verified
- Aug 2019
- First submitted
- 15 Jul 2015
- Last updated
- 16 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Molenaar CJ, van Rooijen SJ, Fokkenrood HJ, Roumen RM, Janssen L, Slooter GD. Prehabilitation versus no prehabilitation to improve functional capacity, reduce postoperative complications and improve quality of life in colorectal cancer surgery. Cochrane Database Syst Rev. 2023 May 10;5(5):CD013259. doi: 10.1002/14651858.CD013259.pub3.
PubMed 37162250Molenaar CJ, van Rooijen SJ, Fokkenrood HJ, Roumen RM, Janssen L, Slooter GD. Prehabilitation versus no prehabilitation to improve functional capacity, reduce postoperative complications and improve quality of life in colorectal cancer surgery. Cochrane Database Syst Rev. 2022 May 19;5(5):CD013259. doi: 10.1002/14651858.CD013259.pub2.
PubMed 35588252Carli F, Bousquet-Dion G, Awasthi R, Elsherbini N, Liberman S, Boutros M, Stein B, Charlebois P, Ghitulescu G, Morin N, Jagoe T, Scheede-Bergdahl C, Minnella EM, Fiore JF Jr. Effect of Multimodal Prehabilitation vs Postoperative Rehabilitation on 30-Day Postoperative Complications for Frail Patients Undergoing Resection of Colorectal Cancer: A Randomized Clinical Trial. JAMA Surg. 2020 Mar 1;155(3):233-242. doi: 10.1001/jamasurg.2019.5474.
PubMed 31968063
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Multimodal Prehabilitation to Improve Outcomes for Frail Patients Undergoing Resection of Colorectal Cancer
- ClinicalTrials.gov ID
- NCT02502760
- Acronym / sponsor ID
- 15-131-MUHC
- Conditions
- Colorectal Neoplasms
- Keywords
- Postoperative Complications, Perioperative Care, Colorectal Surgery, Frail Elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- Sir Mortimer B. Davis - Jewish General Hospital
- Study start
- Aug 2015
- Primary completion
- 19 Jun 2019 (actual)
- Study completion
- 19 Jun 2019 (actual)
- First posted
- 20 Jul 2015 (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.
The purpose of this study is to determine if a program of physical activity, nutritional supplements and relaxation techniques is effective at decreasing post operative complications in frail colorectal cancer patients undergoing resection.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prehabilitation | Experimental | Behavioral: Physical Exercise Program, Dietary Supplement: Whey Protein Isolate Powder, Behavioral: Relaxation TechniquesImmediately after randomization and until surgery, patients in this arm will: 1. - Receive a personalized physical exercise program 2. - Receive nutritional counselling with Whey protein isolate powder 3. - Receive relaxation techniques |
| Rehabilitation | Active comparator | Behavioral: Physical Exercise Program, Dietary Supplement: Whey Protein Isolate Powder, Behavioral: Relaxation TechniquesPatients in this arm will receive the same personalized physical exercise program, nutritional intervention and relaxation techniques as patients in the other arm but to be started after surgery. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Colorectal cancer patient undergoing resection
- Frail or intermediately frail patients (Fried score 2 and above)
Key exclusion criteria (2 listed)
- Unable to communicate in French or English
- Premorbid conditions contraindicating physical exercise (dementia, Parkinson Disease, previous stroke with paresis, taking carbidopa/levodopa, donepezil or antidepressants)
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 |
|---|---|---|
| Physical Exercise ProgramPhysical exercises personalized by a kinesiologist consisting of walking or stationary bike and elastic band exercises. | Behavioural | Prehabilitation, Rehabilitation |
| Whey Protein Isolate PowderNutritional counselling is given to patients to ensure their daily proteins and energy requirements are met. Whey Protein Isolate Powder (Immunocal) is provided. Immunocal1.5g/kg PO (by mouth) per day separated in 2 daily doses | Dietary supplement | Prehabilitation, Rehabilitation |
| Relaxation TechniquesRelaxation techniques consisting of breathing exercises and using a relaxation CD. | Behavioural | Prehabilitation, Rehabilitation |
Primary outcome
Post operative complications
Time frame: 30 days after surgery
Comprehensive Complication Index (CCI)
5 secondary outcomes
6 Minutes Walk Test Distance
Time frame: 4 weeks after discharge
Hospital Length of Stay
Time frame: 3-6 days
Readmission rates
Time frame: 30 days after discharge
Anxiety and Depression
Time frame: 30 days after discharge
Health Related Quality of Life
Time frame: 30 days after discharge
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 Aug 2019.
- Derived from this study: PubMed 37162250Molenaar CJ, van Rooijen SJ, Fokkenrood HJ, Roumen RM, Janssen L, Slooter GD. Prehabilitation versus no prehabilitation to improve functional capacity, reduce postoperative complications and improve quality of life in colorectal cancer surgery. Cochrane Database Syst Rev. 2023 May 10;5(5):CD013259. doi: 10.1002/14651858.CD013259.pub3.
- Derived from this study: PubMed 35588252Molenaar CJ, van Rooijen SJ, Fokkenrood HJ, Roumen RM, Janssen L, Slooter GD. Prehabilitation versus no prehabilitation to improve functional capacity, reduce postoperative complications and improve quality of life in colorectal cancer surgery. Cochrane Database Syst Rev. 2022 May 19;5(5):CD013259. doi: 10.1002/14651858.CD013259.pub2.
- Derived from this study: PubMed 31968063Carli F, Bousquet-Dion G, Awasthi R, Elsherbini N, Liberman S, Boutros M, Stein B, Charlebois P, Ghitulescu G, Morin N, Jagoe T, Scheede-Bergdahl C, Minnella EM, Fiore JF Jr. Effect of Multimodal Prehabilitation vs Postoperative Rehabilitation on 30-Day Postoperative Complications for Frail Patients Undergoing Resection of Colorectal Cancer: A Randomized Clinical Trial. JAMA Surg. 2020 Mar 1;155(3):233-242. doi: 10.1001/jamasurg.2019.5474.
- Individual participant dataSharing planned: Undecided
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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.
Franco Carli, MD, MPhil principal investigator
Professor, Department of Anesthesia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Exercise Program, Whey Protein Isolate Powder and Relaxation Techniques in people with Colorectal Neoplasms, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 2 sites in Canada.
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 2 inclusion and 2 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 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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?
Post operative complications (time frame: 30 days after surgery). 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 NCT02502760, 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 16 Aug 2019.