Protein Needs Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-80
SponsorUniversity of Alberta
About this trial
Severe muscle loss in patients with cancer has been associated with increased physical disability, extended hospitalization, infectious and noninfectious complications, increased risk of severe toxicity during cancer treatment, poor quality of life and shortened survival. Adequate protein is key to sustain muscle mass and overall health. However, current nutritional recommendations are not specific or evidence-based. The aim of this project is to determine the protein needs of patients with colorectal or breast cancer. Protein needs will be determined using a novel, non-invasive approach. Our results will inform nutritional recommendations and guidelines with the ultimate goal of improving outcomes for people with cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Outpatients age 45-80 years;
Patients attending the new patient clinic at the Cross Cancer Institute with a diagnosis of colorectal cancer or breast cancer (stages II to III);
Able to complete baseline visits within approximately 4 weeks of starting chemotherapy OR after a minimum of 4 weeks post-surgery if not undergoing chemotherapy;
Ambulatory.
Disqualifiers
Premenopausal women due to impact on protein requirements;
Received anti-cancer hormone treatment or immunotherapy in the 4 weeks before first baseline visit;
Renal impairment based on a creatinine clearance for estimated glomerular filtration rate (eGFR) of <60 mL/min
Abnormal glucose metabolism based on a fasting glucose level >6mmol/L and an HbA1c >5.7% or as reviewed by study team;
Trial design
Design model
Single group
Treatments tested in this trial
Phenylalanine intake
Dietary supplementOral consumption of eight hourly experimental meals- Includes 4 tracer-free experimental meals containing a mixture of free amino acids, calories from a flavored liquid and protein-free cookies and 4 labeled amino acid experimental meals.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Phenylalanine intakeExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
13C Phenylalanine Oxidation
Breath, urine and blood samples will be collected during the study to measure the rate of oxidation of 13C phenylalanine.
Time frame
8.5 hoursSponsors and contacts
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Source ClinicalTrials.gov