RecruitingNot ApplicableNCT04144907

Protein Needs Study

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


Sponsor

University of Alberta

Enrollment

40 participants

Start Date

Apr 26, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 45 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is examining how much protein people need while undergoing treatment for colorectal or breast cancer. It aims to better understand protein requirements during cancer treatment to help improve nutrition guidance for cancer patients. **You may be eligible if...** - You are between 45 and 80 years old - You have been diagnosed with colorectal or breast cancer (stages II or III) - You are receiving treatment at the Cross Cancer Institute in Canada - You are ambulatory (able to walk and move around) and an outpatient - You can start study visits within about 4 weeks of starting chemotherapy, or at least 4 weeks after surgery if not on chemotherapy **You may NOT be eligible if...** - You are a premenopausal woman - You have received hormone therapy or immunotherapy in the 4 weeks before the first study visit - You have kidney problems (low eGFR) - You have uncontrolled high blood sugar (diabetes) - You have other significant health conditions or take medications that would interfere with the study - You are unable or unwilling to provide blood, urine, and breath samples, or to eat the study meals provided - You are substance dependent and unable to follow study protocols Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTPhenylalanine intake

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.


Locations(1)

University of Alberta

Edmonton, Alberta, Canada

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NCT04144907


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