NCT04144907Recruiting
Protein Needs Study
Innovative Approaches to the Lack of Evidence-based Dietary Protein Requirements for Patients With Cancer
Source: ClinicalTrials.gov · Last updated 27 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 28 Oct 2019
- Start date
- 26 Apr 2021
- Primary completion date
- 30 Sept 2030
- Lead sponsor
- University of Alberta
- Diseases
- Colorectal cancer
- NCT number
- NCT04144907
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 26 Apr 2021 to the primary completion date, 30 Sept 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Received anti-cancer hormone treatment or immunotherapy in the 4 weeks before first baseline visit;
- 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.
Other illness
- 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);
Lab values
- 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;
Other
- Premenopausal women due to impact on protein requirements;
- Unable/unwilling to provide urine, breath and blood samples (e.g. oxygen tank, catheter, etc.);
Who the study is looking for
- 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.
Age in the registry: 45 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Alberta Coordinator of this site? Confirm its status | Edmonton | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.