Colorectal NeoplasmNCT01542281
Pre-habilitation to Improve Outcomes in Patients Undergoing Liver Resection for Cancer
A study testing Whey protein and dietary supplements and prehab exercise in people with Colorectal Neoplasm and Biliary Tract Neoplasm, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
1. To determine whether a combined nutritional support program and exercise-based prehabilitation is superior to nutritional support alone in increasing functional recovery and reducing post-operative morbidity after surgery for HPB malignancy. 2. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Neoplasm, Biliary Tract Neoplasm, Liver Neoplasm
- What is being tested?
- Whey protein and dietary supplements and prehab exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2012to Jan 2015
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects eligible to enter the prehabilitation program will include those aged 18 and above and referred electively for resection of malignancies.
Who cannot join
- Excluded will be persons with American Society of Anesthesiologists (ASA) health status class 4-5 or co-morbid medical, physical and mental conditions (e.g. dementia, disabling orthopedic and neuromuscular disease, psychosis), cardiac abnormalities, severe end-organ disease such as cardiac failure, COPD, and hepatic failure (ALT and AST >50% over the normal range), and sepsis), morbid obesity (BMI >40), anemia (hematocrit < 30 %) and other conditions interfering with the ability to perform exercise at home or to complete the testing procedures.
- Patients will be excluded if they have poor English or French comprehension.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Royal Victoria Hospital
Montreal, Quebec, H3A1A1
Ayat Salman, MSccandidate, 5149341934 ext. 36237, ayat.salman@muhc.mcgill.ca
Prosanto Chaudhury, MD
About this study
Official title: Improving Outcomes in Patients With Hepatobiliary Cancers With a Nutritional and Physical Conditioning Pre-habilitation Program
- To determine whether a combined nutritional support program and exercise-based prehabilitation is superior to nutritional support alone in increasing functional recovery and reducing post-operative morbidity after surgery for HPB malignancy.
- To understand which measures of immediate surgical recovery are sensitive to prehabilitation interventions and predict change in later outcome measures.
Read the detailed description
Patients scheduled for elective liver resection be will be approached andrandomized to one of two groups using a computer generated block randomisation scheme. The first group (pre-hab) will receive both nutritional supplementation and a prehabilitation program as outlined below. The second group (nutrition) will receive only nutritional supplementation. Both groups will be given a post-operative exercise program.
Once randomized, the subjects will be called by the research co-ordinator and an appointment will be made for the initial assessment. After the study is explained and consent obtained, subjects will be tested on 6MWT, followed by a 30 minute rest period during which various questionnaires assessing physical activity, quality of life, fatigue and nutritional status will be completed with the aid of the coordinator.
The prehabilitation program will last a minimum of four weeks and a maximum of 8 weeks.
Surgery will be performed by one of the HPB surgeons at the McGill University Health Center. Surgical approach, including laparoscopic or open surgery will be at the discretion of the surgeon. Perioperative care will follow an Enhanced Recovery After Surgery (ERAS)-based clinical care pathway27, 28, a fast-track care plan including patient education, afferent neural blockade, multimodal analgesia, early oral intake and mobilization, early removal of catheters and drains, and a planned 6-8 day hospital admission. This pathway has already been implemented at the Royal Victoria Hospital as part of standard patient care.
- Conditions
- Colorectal Neoplasm, Biliary Tract Neoplasm, Liver Neoplasm
- Being tested
- Whey protein and dietary supplements, prehab exercise
- Keywords
- liver resection, hepatectomy, pre-habilitation
- Medical subject headings
- Colorectal Neoplasms, Biliary Tract Neoplasms, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whey protein and dietary supplementsDietary supplement
Whey protein and dietary supplements in addition to pre-hab exercise
prehab exerciseOther
Also called weight training , walking, cycling etc.
minimum 4 weeks and maximum 8 weeks; 3 times a week
| Study group | Role | What they receive |
|---|---|---|
| Nutritional supplementation and prehab | Experimental | The first group (pre-hab) will receive both nutritional supplementation and a prehabilitation program. Receives: Dietary Supplement: Whey protein and dietary supplements |
| Prehab exercise | Active comparator | Not described Receives: Other: prehab exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in six minute walk test
The primary outcome is patient-relevant, functional walking capacity as measured by the six-minute walk test (6MWT). The 6MWT evaluates the ability of an individual to maintain a moderate level of physical activity over a time period reflective of the activities of daily living
Measured: 8 weeks pre-op and 1 week pre-op
Secondary outcomes (6)
post-operative complications
Postoperative complications including surgical site infection, other infectious complications (such as pneumonia, urinary tract infection, line sepsis), bile leak, hemmorrhage, deep vein thrombosis, etc., will be recorded and scored using the Clavien Classification.
Measured: 30 days
Health-related quality of life (HRQL)
Health-related quality of life (HRQL) as measured by the acute (1 week recall period) SF-36 health survey. The SF-36 is the most widely used HRQL measure and has been validated for surgical population; Canadian norms are also available.
Measured: 8 and 1 week pre-operatively, 4 and 8 weeks post-operatively
Physical activity level
Physical activity level will be measured through the Community Health Activities Model Program for Seniors (CHAMPS) questionnaire. The CHAMPS is a self-reported measure of physical activity, comprising 41 activities evaluated according to the total number of hours done during an average week.
Measured: 8 and 1 weeks pre-operatively, 4 and 8 weeks post-operatively
Depression and anxiety
Depression and anxiety will be assessed by The Hospital Anxiety and Depression Scale (HADS), a 14-question measure with seven items each for depression and anxiety. HADS generates separate scores for anxiety and depression as well as a combined score of psychological distress.
Measured: 8 and 1 weeks pre-operatively, 4 and 8 weeks post-operatively
Fatigue
Fatigue will be assessed using a visual analog scale (1-10) and the Brief Fatigue Inventory (BFI). The BFI assesses the level of fatigue and its impact on activities of daily living44
Measured: 8 and 1 weeks pre-operatively, 4 and 8 weeks post-operatively
Nutritional status
Nutritional status will be assessed through subjective and objective evaluations.Body composition will be measured by bioimpedance assay.Assessment of usual food intake will be performed using the 3-day, 24-hour food recall method. The scored Patient Generated Subjective Global Assessment (sPG-SGA) is a validated questionnaire used to assess the nutritional and functional status of cancer patients.
Measured: 8 and 1 weeks pre-operatively, 4 and 8 weeks post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2012 (estimated)
- Study startJan 2012
- Primary completionJan 2014 (estimated)
- Study completionJan 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmStudies 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
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prosanto Chaudhury, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Prosanto Chaudhury, MD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01542281
- Sponsor's protocol ID
- BMA-10-375
- Status last verified
- Feb 2012
- First submitted
- 16 Feb 2012
- Last updated
- 2 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Outcomes in Patients With Hepatobiliary Cancers With a Nutritional and Physical Conditioning Pre-habilitation Program
- ClinicalTrials.gov ID
- NCT01542281
- Acronym / sponsor ID
- BMA-10-375
- Conditions
- Colorectal Neoplasm, Biliary Tract Neoplasm, Liver Neoplasm
- Keywords
- liver resection, hepatectomy, pre-habilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Jan 2015 (estimated)
- First posted
- 2 Mar 2012 (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.
- To determine whether a combined nutritional support program and exercise-based prehabilitation is superior to nutritional support alone in increasing functional recovery and reducing post-operative morbidity after surgery for HPB malignancy.
- To understand which measures of immediate surgical recovery are sensitive to prehabilitation interventions and predict change in later outcome measures.
Detailed description
Patients scheduled for elective liver resection be will be approached andrandomized to one of two groups using a computer generated block randomisation scheme. The first group (pre-hab) will receive both nutritional supplementation and a prehabilitation program as outlined below. The second group (nutrition) will receive only nutritional supplementation. Both groups will be given a post-operative exercise program.
Once randomized, the subjects will be called by the research co-ordinator and an appointment will be made for the initial assessment. After the study is explained and consent obtained, subjects will be tested on 6MWT, followed by a 30 minute rest period during which various questionnaires assessing physical activity, quality of life, fatigue and nutritional status will be completed with the aid of the coordinator.
The prehabilitation program will last a minimum of four weeks and a maximum of 8 weeks.
Surgery will be performed by one of the HPB surgeons at the McGill University Health Center. Surgical approach, including laparoscopic or open surgery will be at the discretion of the surgeon. Perioperative care will follow an Enhanced Recovery After Surgery (ERAS)-based clinical care pathway27, 28, a fast-track care plan including patient education, afferent neural blockade, multimodal analgesia, early oral intake and mobilization, early removal of catheters and drains, and a planned 6-8 day hospital admission. This pathway has already been implemented at the Royal Victoria Hospital as part of standard patient care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutritional supplementation and prehab | Experimental | Dietary Supplement: Whey protein and dietary supplementsThe first group (pre-hab) will receive both nutritional supplementation and a prehabilitation program. |
| Prehab exercise | Active comparator | Other: prehab exercise |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects eligible to enter the prehabilitation program will include those aged 18 and above and referred electively for resection of malignancies.
Key exclusion criteria (2 listed)
- Excluded will be persons with American Society of Anesthesiologists (ASA) health status class 4-5 or co-morbid medical, physical and mental conditions (e.g. dementia, disabling orthopedic and neuromuscular disease, psychosis), cardiac abnormalities, severe end-organ disease such as cardiac failure, COPD, and hepatic failure (ALT and AST >50% over the normal range), and sepsis), morbid obesity (BMI >40), anemia (hematocrit < 30 %) and other conditions interfering with the ability to perform exercise at home or to complete the testing procedures.
- Patients will be excluded if they have poor English or French comprehension.
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 |
|---|---|---|
| Whey protein and dietary supplementsWhey protein and dietary supplements in addition to pre-hab exercise | Dietary supplement | Nutritional supplementation and prehab |
| prehab exerciseAlso: weight training , walking, cycling etc.minimum 4 weeks and maximum 8 weeks; 3 times a week | Other | Prehab exercise |
Primary outcome
Change in six minute walk test
Time frame: 8 weeks pre-op and 1 week pre-op
The primary outcome is patient-relevant, functional walking capacity as measured by the six-minute walk test (6MWT). The 6MWT evaluates the ability of an individual to maintain a moderate level of physical activity over a time period reflective of the activities of daily living
6 secondary outcomes
post-operative complications
Time frame: 30 days
Health-related quality of life (HRQL)
Time frame: 8 and 1 week pre-operatively, 4 and 8 weeks post-operatively
Physical activity level
Time frame: 8 and 1 weeks pre-operatively, 4 and 8 weeks post-operatively
Depression and anxiety
Time frame: 8 and 1 weeks pre-operatively, 4 and 8 weeks post-operatively
Fatigue
Time frame: 8 and 1 weeks pre-operatively, 4 and 8 weeks post-operatively
Nutritional status
Time frame: 8 and 1 weeks pre-operatively, 4 and 8 weeks post-operatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2012.
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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.
Prosanto Chaudhury, MD principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whey protein and dietary supplements and prehab exercise in people with Colorectal Neoplasm and Biliary Tract Neoplasm, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site 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 1 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: status not confirmed, as of the sponsor's last update on 2 Mar 2012. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ayat Salman, MSccandidate (5149341934 ext. 36237, ayat.salman@muhc.mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in six minute walk test (time frame: 8 weeks pre-op and 1 week pre-op). 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 2 Mar 2012.