Prehabilitation for Colorectal Cancer Patients With Low Functional Capacity and Malnutrition
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorMcGill University
About this trial
Despite multi-modal prehabilitation (nutrition, exercise, and psychosocial interventions), 60% of older elective colorectal cancer surgery patients with poor physical function were unable to reach a minimum preoperative 400m six-minute walking distance (6MWD), a prognostic cut-point. Compared to the patients that attained \>400m 6MWD preoperatively, twice as many of \<400m patients were malnourished. Malnutrition has long been associated with worse functioning (e.g., physical, immune). The investigators hypothesize that for nutritionally deficient patients, the etiology for their poor physical function is malnutrition. Correction of malnutrition alone might thus be sufficient to achieve a 400m 6MWD before surgery and improve patient outcomes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged 65 years and older;
Patients with cancer scheduled for primary colorectal resection;
Patients with 6MWD at baseline less than 400 m;
Patients with Patient-Generated Subjective-Global Assessment (malnutrition assessment) score equal or greater than 9.
Disqualifiers
Patients with history of premorbid conditions that contraindicate exercise including dementia, -Parkinson's disease or previous stroke with paresis;
Metastatic cancer;
Patients who do not speak English or French and cannot be accompanied by someone who speaks English or French;
Trial design
Design model
Parallel
Treatments tested in this trial
Nutrition
BehavioralThe nutrition intervention will be based on needs assessed by indirect calorimetry, patient-generated subjective global assessment, and 24hr recall conducted at baseline, enabling individualized caloric and protein targets. Deficits in nutrient intake will be addressed with one-on-one dietary counselling and supplementation at baseline in a quantity that matches the estimated deficit in intake. Adherence will be monitored using 24-hr recalls and weight status by the dietitian weekly.
Exercise
BehavioralThe exercise intervention will include both a resistance and an aerobic component to be performed a total of 5 times a day, 5 times per week, 5 minutes each session, totaling 125 minutes per week. The ability to perform exercises as prescribed will be monitored with a weekly in-person or virtual supervised session.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Nutrition and exerciseOther 2 interventions
Group B: Nutrition onlyOther 1 intervention
Trial outcomes
Primary outcomes
1
Preoperative six-minute walking distance
Physical function will be measured with the six-minute walking test (6MWT). Patients will be instructed to walk back and forth along a 20m hallway, and the distance covered in 6 minutes (6MWD) will be recorded (meters).
Time frame
from date of baseline assessment until date of surgery, an average of 4 weeks, recorded in metersSecondary outcomes
1
Adherence to the exercise intervention
Adherence will be monitored by use of logbooks and a smart watch (FitBit), which records daily steps.
Time frame
from date of baseline assessment until date of surgery,an average of 4 weeks, recorded in steps2
Adherence to the nutrition intervention
Adherence to dietary targets (energy intake) will be carefully monitored by weekly in-person or virtual visit using 24hr recalls and supplement counts (energy consumption as compared to prescribed energy targets)
Time frame
from date of baseline assessment until date of surgery, an average of 4 weeks, recorded in % of prescription adherence3
Adherence to the nutrition intervention
Adherence to dietary targets (protein intake) will be carefully monitored by weekly in-person or virtual visit using 24hr recalls and supplement counts (protein consumption as compared to prescribed protein targets)
Time frame
from date of baseline assessment until date of surgery, an average of 4 weeks, recorded in % of prescription adherenceSponsors and contacts
Click on the lead sponsor to view all of their trials.
McGill University
Lead sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborator
Source ClinicalTrials.gov