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Taking people in CanadaNo phase

Testing how much protein people with colorectal or breast cancer need

Tests phenylalanine intake, a dietary protein component, in adults with colorectal or breast cancer.

Plain-language title generated from the registry record
Registry title: Protein Needs Study

Key facts

Where
Edmonton, CanadaSee the site

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 45 and 80 years old?

Source: NCT04144907, who can take part

Where in Canada

  • University of AlbertaEdmonton, CanadaTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

Trial details

Who runs it
University of Alberta
Trial code
NCT04144907
Record updated
27 October 2026
Original description
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.Read full original descriptionShow less

Innovative Approaches to the Lack of Evidence-based Dietary Protein Requirements for Patients With Cancer

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.

Inclusion: 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.

Exclusion: 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; 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); 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; Premenopausal women due to impact on protein requirements; Unable/unwilling to provide urine, breath and blood samples (e.g. oxygen tank, catheter, etc.).

ClinicalTrials.gov NCT04144907