Protein Needs Study (NCT04144907)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (4 items) and avoid the listed exclusions (9 items).
Location: University of Alberta — Edmonton, Alberta
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- 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;
- Comorbidities or medications that would interfere with the participants ability to follow the study protocol or the quality of the data(e.g. diabetes, class III obesity, hormone therapy, another active cancer diagnosis);
- Unable/unwilling to provide urine, breath and blood samples (e.g. oxygen tank, catheter, etc.);
- Unable to eat the meals provided (i.e. receiving parenteral or enteral nutrition, severe allergies);
- Substance dependent (e.g. alcohol, cigarettes, illicit drugs) and unable to follow study protocols.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- University of Alberta — Edmonton, Alberta
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.