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Protein Needs Study

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

NCT04144907•University of Alberta

Summary

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

Age

45 - 80 years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

University of Alberta

Edmonton, Alberta, Canada

Key Dates

Start Date

April 26, 2021

Primary Completion Date

December 31, 2025

Completion Date

December 31, 2025

Last Updated

December 16, 2024

Enrollment

ESTIMATED participants

Conditions

Colorectal CancerBreast Cancer

Interventions

Phenylalanine intake

DIETARY_SUPPLEMENT

Contacts

Anne Caretero, RD

CONTACT

780-492-7820 caretero@ualberta.ca

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 16, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Protein Needs Study

Inclusion Criteria

Exclusion Criteria

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