Colon CancerNCT01919541
Mechanistic Prehabilitation
A study testing Prehabilitation, hyperinsulinemic euglycemic isoaminoacid clamp and hyperinsulinemic euglycemic hyperaminoacid clamp in people with Colon Cancer and Rectal Cancer, run by Franco Carli at 1 site in Canada.
Trial summary
The investigators hypothesize that individuals who receive a personalized 4 week prehabilitation program consisting of exercise and nutrition counselling with post-workout whey protein supplementation will show, before colorectal surgery, improved insulin sensitivity, inflammatory profile, and substrate utilization… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Colon Cancer, Rectal Cancer
- What is being tested?
- Prehabilitation, hyperinsulinemic euglycemic isoaminoacid clamp and hyperinsulinemic euglycemic hyperaminoacid clamp
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2016to Dec 2016
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients scheduled for elective colorectal surgery for cancer
- 65 years and older
Who cannot join
- American Society of Anesthesiologists (ASA) health status class 4-5
- disabling co-morbid physical and mental conditions (e.g. orthopedic and neuromuscular disease, dementia, psychosis)
- endocrine disorders (diabetes or hemoglobin A1C>6, hyper and hypothyrodisim)
- steroid consumption
- cardiac failure (New York Heart Association classes I-IV)
- chronic obstructive pulmonary disease
Show all 11Show fewer
- renal failure (creatinine > 115µmol/l)
- hepatic failure (liver aminotranferases >50% the normal range)
- morbid obesity (BMI >40)
- anemia (hematocrit < 30 %, haemoglobin <100 g/L, albumin < 25 g/L)
- poor comprehension of English or French
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Understanding How Exercise and Nutrition Enhance Preoperative Functional Capacity: a Mechanistic Study
The investigators hypothesize that individuals who receive a personalized 4 week prehabilitation program consisting of exercise and nutrition counselling with post-workout whey protein supplementation will show, before colorectal surgery, improved insulin sensitivity, inflammatory profile, and substrate utilization compared to baseline measures. These results will translate into a higher functional capacity before surgery as demonstrated by an improvement in 6-minute walking test.
Read the detailed description
Intervention Physical exercise program
At the baseline assessment all patients' physical fitness will be evaluated by the kinesiologist (exercise specialist). The exercise component will consist of approximately 60 min of resistance and aerobic training, for a minimum of 3 days per week. The exercise program will be individualized based upon the baseline fitness test (according to the American College of Sport Medicine, ACMS, standard)50 and will include: a 5 min warm-up, either 25 min of aerobic exercise (starting at 30- 40 % of heart rate reserve, HRR), and 25 min of resistance training (8 exercises targeting major muscle groups performed at moderate intensity), and a 5-10 min cool-down and stretching period. All exercises will be clearly explained and demonstrated by the kinesiologist at baseline. Patients will be asked to carry out this program at home, unsupervised, but will be monitored with weekly telephone calls. Training intensity progression will occur when the participant can complete aerobic exercise on mild exertion and/or when the participant can complete 15 repetitions of a given resistance exercise. Participants will be provided with resistance bands and an exercise mat, as well as a pedometer and a heart rate monitor, which can be used by the participant to monitor progress and by the kinesiologist to monitor daily compliance. A log book will also be completed to report all activities and frequency of exercises completed.
The kinesiologist will follow (by telephone call) all the participants on a weekly basis to ensure program compliance and address any barriers that may prevent ongoing participation.
Nutritional counseling The patients' nutritional status and adequacy of dietary intake will be assessed by a nutritionist using a three day food record, biological indices (e.g. glycated hemoglobin), clinical history, and the Patient-Generated Subjective Global Assessment tool51. Anthropometric measures, including percentage of lean body mass and fat, will be measured with bioelectrical impedance and skin calipers. Nutritional care plans will focus on meeting daily protein requirements (1.2g/kg), management of cancer-related symptoms (such as diarrhea, constipation), blood glucose control, optimization of body composition (i.e. weight loss/gain if necessary) and nutrient intake through providing practical suggestions, based on actual intake, to improve macronutrient distributions of protein, fat, and carbohydrates.
The type of dietary protein (amino acid composition), digestibility, amount, timing of intake, and co-ingestion with other macronutrients can be used to capitalize on post-exercise induced muscle protein synthesis52. Twenty (20) grams of protein, in liquid form, taken immediately after resistance exercise is regarded as sufficient to maximally stimulate muscle protein synthesis in healthy individuals52. Whey protein, in particular, is regarded as being especially effective when ingested after exercise54 because it is rapidly digested and contains all of the indispensable amino acids including leucine, which is believed to independently stimulate translation initiation of protein synthesis in skeletal muscle52. Post exercise co-ingestion with carbohydrate does not appear to provide any further anabolic effect, although does improve protein balance by blunting proteolysis and maximally stimulating insulin secretion55.
The nutritionist will provide patients with a post-workout nutrition prescription consisting of 20g of whey protein52 and 1g/kg carbohydrates53. Elderly patients require at least a 20g dose of dietary protein after resistance exercise and approximately 30g doses, in intervals, within the 24h "window of anabolic opportunity" in order to simulate an anabolic response 52.54,61. Ingestion of 1-1.5g carbohydrate/kg, within the "glycogen recovery window" of 15-30 minutes after exercise, replenishes glycogen stores53.
To ensure compliance, patients will be asked to complete daily logs and to return their empty sachets of whey protein.
Relaxation Strategies The kinesiologists will instruct patients to perform deep breathing exercises for relaxation purposes. Patients will be instructed to perform these exercises daily and as needed. Relaxation CD's, including soothing sounds, will also be given to patients.
- Conditions
- Colon Cancer, Rectal Cancer
- Being tested
- Prehabilitation, hyperinsulinemic euglycemic isoaminoacid clamp, hyperinsulinemic euglycemic hyperaminoacid clamp, whey protein supplementation
- Keywords
- Colorectal Surgery
- Medical subject headings
- Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrehabilitationOther
All patients will receive a prehabilitation program, which involves a personalized exercise component provided by a kinesiologist.
hyperinsulinemic euglycemic isoaminoacid clampDevice
A hyperinsulinemic euglycemic isoaminoacid clamp followed by a hyperinsulinemic euglycemic hyperaminoacid clamp performed at baseline and immediately before surgery will provide insight into insulin resistance of glucose and protein metabolism in colorectal cancer patients pre- and post-intervention. Similarly, simultaneous infusions of leucine and glucose stable isotopes will provide insight into baseline and interventional effects of the program on whole body leucine and glucose kinetics.
hyperinsulinemic euglycemic hyperaminoacid clampDevice
whey protein supplementationDietary supplement
PrehabilitationOther
All patients will receive nutrition guidance and a nutrition component with whey protein supplementation.
| Study group | Role | What they receive |
|---|---|---|
| Prehabilitation | Other | All patients will receive a prehabilitation program involving an individualized exercise and nutrition program 4 weeks before surgery. Whole body protein kinetics and insulin resistance will be determined at the beginning of the program and at the end of the program. Receives: Other: Prehabilitation; Device: hyperinsulinemic euglycemic isoaminoacid clamp; Device: hyperinsulinemic euglycemic hyperaminoacid clamp; Dietary Supplement: whey protein supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protein Synthesis
The change in whole body protein synthesis, measured using stable isotope technology, from baseline to date of surgery, will be documented, in response to hyperinsulinemia with the use of a hyperinsulinemic euglycemic hyperaminoacidemic clamp.
Measured: up to 4 weeks before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2013 (estimated)
- Study startDec 2016
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Why it stopped: difficulty in recruiting patients
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 Colon 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Franco Carli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Franco Carli, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Franco Carli, MD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01919541
- Sponsor's protocol ID
- 13-127-GEN
- Status last verified
- Sep 2015
- First submitted
- 31 Jul 2013
- Last updated
- 22 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Li C, Carli F, Lee L, Charlebois P, Stein B, Liberman AS, Kaneva P, Augustin B, Wongyingsinn M, Gamsa A, Kim DJ, Vassiliou MC, Feldman LS. Impact of a trimodal prehabilitation program on functional recovery after colorectal cancer surgery: a pilot study. Surg Endosc. 2013 Apr;27(4):1072-82. doi: 10.1007/s00464-012-2560-5. Epub 2012 Oct 9.
PubMed 23052535
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding How Exercise and Nutrition Enhance Preoperative Functional Capacity: a Mechanistic Study
- ClinicalTrials.gov ID
- NCT01919541
- Acronym / sponsor ID
- 13-127-GEN
- Conditions
- Colon Cancer, Rectal Cancer
- Keywords
- Colorectal Surgery
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: difficulty in recruiting patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Franco CarliUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 9 Aug 2013 (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 investigators hypothesize that individuals who receive a personalized 4 week prehabilitation program consisting of exercise and nutrition counselling with post-workout whey protein supplementation will show, before colorectal surgery, improved insulin sensitivity, inflammatory profile, and substrate utilization compared to baseline measures. These results will translate into a higher functional capacity before surgery as demonstrated by an improvement in 6-minute walking test.
Detailed description
Intervention Physical exercise program
At the baseline assessment all patients' physical fitness will be evaluated by the kinesiologist (exercise specialist). The exercise component will consist of approximately 60 min of resistance and aerobic training, for a minimum of 3 days per week. The exercise program will be individualized based upon the baseline fitness test (according to the American College of Sport Medicine, ACMS, standard)50 and will include: a 5 min warm-up, either 25 min of aerobic exercise (starting at 30- 40 % of heart rate reserve, HRR), and 25 min of resistance training (8 exercises targeting major muscle groups performed at moderate intensity), and a 5-10 min cool-down and stretching period. All exercises will be clearly explained and demonstrated by the kinesiologist at baseline. Patients will be asked to carry out this program at home, unsupervised, but will be monitored with weekly telephone calls. Training intensity progression will occur when the participant can complete aerobic exercise on mild exertion and/or when the participant can complete 15 repetitions of a given resistance exercise. Participants will be provided with resistance bands and an exercise mat, as well as a pedometer and a heart rate monitor, which can be used by the participant to monitor progress and by the kinesiologist to monitor daily compliance. A log book will also be completed to report all activities and frequency of exercises completed.
The kinesiologist will follow (by telephone call) all the participants on a weekly basis to ensure program compliance and address any barriers that may prevent ongoing participation.
Nutritional counseling The patients' nutritional status and adequacy of dietary intake will be assessed by a nutritionist using a three day food record, biological indices (e.g. glycated hemoglobin), clinical history, and the Patient-Generated Subjective Global Assessment tool51. Anthropometric measures, including percentage of lean body mass and fat, will be measured with bioelectrical impedance and skin calipers. Nutritional care plans will focus on meeting daily protein requirements (1.2g/kg), management of cancer-related symptoms (such as diarrhea, constipation), blood glucose control, optimization of body composition (i.e. weight loss/gain if necessary) and nutrient intake through providing practical suggestions, based on actual intake, to improve macronutrient distributions of protein, fat, and carbohydrates.
The type of dietary protein (amino acid composition), digestibility, amount, timing of intake, and co-ingestion with other macronutrients can be used to capitalize on post-exercise induced muscle protein synthesis52. Twenty (20) grams of protein, in liquid form, taken immediately after resistance exercise is regarded as sufficient to maximally stimulate muscle protein synthesis in healthy individuals52. Whey protein, in particular, is regarded as being especially effective when ingested after exercise54 because it is rapidly digested and contains all of the indispensable amino acids including leucine, which is believed to independently stimulate translation initiation of protein synthesis in skeletal muscle52. Post exercise co-ingestion with carbohydrate does not appear to provide any further anabolic effect, although does improve protein balance by blunting proteolysis and maximally stimulating insulin secretion55.
The nutritionist will provide patients with a post-workout nutrition prescription consisting of 20g of whey protein52 and 1g/kg carbohydrates53. Elderly patients require at least a 20g dose of dietary protein after resistance exercise and approximately 30g doses, in intervals, within the 24h "window of anabolic opportunity" in order to simulate an anabolic response 52.54,61. Ingestion of 1-1.5g carbohydrate/kg, within the "glycogen recovery window" of 15-30 minutes after exercise, replenishes glycogen stores53.
To ensure compliance, patients will be asked to complete daily logs and to return their empty sachets of whey protein.
Relaxation Strategies The kinesiologists will instruct patients to perform deep breathing exercises for relaxation purposes. Patients will be instructed to perform these exercises daily and as needed. Relaxation CD's, including soothing sounds, will also be given to patients.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prehabilitation | Other | Other: Prehabilitation, Device: hyperinsulinemic euglycemic isoaminoacid clamp, Device: hyperinsulinemic euglycemic hyperaminoacid clamp, Dietary Supplement: whey protein supplementationAll patients will receive a prehabilitation program involving an individualized exercise and nutrition program 4 weeks before surgery. Whole body protein kinetics and insulin resistance will be determined at the beginning of the program and at the end of the program. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Patients scheduled for elective colorectal surgery for cancer
- 65 years and older
Key exclusion criteria (11 listed)
- American Society of Anesthesiologists (ASA) health status class 4-5
- disabling co-morbid physical and mental conditions (e.g. orthopedic and neuromuscular disease, dementia, psychosis)
- endocrine disorders (diabetes or hemoglobin A1C>6, hyper and hypothyrodisim)
- steroid consumption
- cardiac failure (New York Heart Association classes I-IV)
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 |
|---|---|---|
| PrehabilitationAll patients will receive a prehabilitation program, which involves a personalized exercise component provided by a kinesiologist. | Other | Prehabilitation |
| hyperinsulinemic euglycemic isoaminoacid clampA hyperinsulinemic euglycemic isoaminoacid clamp followed by a hyperinsulinemic euglycemic hyperaminoacid clamp performed at baseline and immediately before surgery will provide insight into insulin resistance of glucose and protein metabolism in colorectal cancer patients pre- and post-intervention. Similarly, simultaneous infusions of leucine and glucose stable isotopes will provide insight into baseline and interventional effects of the program on whole body leucine and glucose kinetics. | Device | Prehabilitation |
| hyperinsulinemic euglycemic hyperaminoacid clamp | Device | Prehabilitation |
| whey protein supplementation | Dietary supplement | Prehabilitation |
| PrehabilitationAll patients will receive nutrition guidance and a nutrition component with whey protein supplementation. | Other | Prehabilitation |
Primary outcome
Protein Synthesis
Time frame: up to 4 weeks before surgery
The change in whole body protein synthesis, measured using stable isotope technology, from baseline to date of surgery, will be documented, in response to hyperinsulinemia with the use of a hyperinsulinemic euglycemic hyperaminoacidemic clamp.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2018.
- Background: PubMed 23052535Li C, Carli F, Lee L, Charlebois P, Stein B, Liberman AS, Kaneva P, Augustin B, Wongyingsinn M, Gamsa A, Kim DJ, Vassiliou MC, Feldman LS. Impact of a trimodal prehabilitation program on functional recovery after colorectal cancer surgery: a pilot study. Surg Endosc. 2013 Apr;27(4):1072-82. doi: 10.1007/s00464-012-2560-5. Epub 2012 Oct 9.
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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 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 Prehabilitation, hyperinsulinemic euglycemic isoaminoacid clamp and hyperinsulinemic euglycemic hyperaminoacid clamp in people with Colon Cancer and Rectal Cancer, run by Franco Carli 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 2 inclusion and 11 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: withdrawn, as of the sponsor's last update on 22 Mar 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 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 was withdrawn before enrolling participants, so there are no results.
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?
Protein Synthesis (time frame: up to 4 weeks before 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 NCT01919541, 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 22 Mar 2018.