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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2025
  • participants needed
    30
  • sponsor
    University of Alberta
Updated on 27 October 2022
adjuvant chemotherapy

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.

Details
Condition Colorectal Cancer, Breast Cancer
Treatment Phenylalanine intake
Clinical Study IdentifierNCT04144907
SponsorUniversity of Alberta
Last Modified on27 October 2022

Eligibility

Yes No Not Sure

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
Unable/unwilling to provide urine, breath and blood samples (e.g. oxygen tank, catheter, etc.)
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 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
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