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NCT Number: NCT04144907

Protein Needs Study

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.

Recruiting

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Key information

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alberta

Edmonton, Alberta, T6G 2R3, Canada

Location status: Recruiting

Location contact

Anne Caretero, RD

CONTACT

[email protected]

780-492-7820

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 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.

Treatment and study plan

Phenylalanine intake

Dietary Supplement

Oral 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.

Primary outcomes

  1. 13C Phenylalanine Oxidation

    Time frame: 8.5 hours

    Breath, urine and blood samples will be collected during the study to measure the rate of oxidation of 13C phenylalanine.

Study contacts

Contact information is provided by the study sponsor or research team.

Anne Caretero, RD

CONTACT

[email protected]

780-492-7820

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2030
Study completion
2030
First posted
Oct 30, 2019
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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