Protein Needs Study

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Colorectal Cancer
• Intervention / Treatment: Dietary supplement: Phenylalanine intake

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anne Caretero, RD; Phone Number: 780-492-7820; Email: caretero@ualberta.ca

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2R3
      • Recruiting
      • University of Alberta
      • Contact: Anne Caretero, RD; Phone Number: 780-492-7820; Email: caretero@ualberta.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phenylalanine intake	Dietary supplement: Phenylalanine 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
13C Phenylalanine Oxidation	Breath, urine and blood samples will be collected during the study to measure the rate of oxidation of 13C phenylalanine.	8.5 hours

Collaborators and Investigators

• Sponsor: University of Alberta
• Investigators: Principal Investigator: Carla Prado, PhD, RD, University of Alberta

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2021
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: October 28, 2019
• First Submitted That Met QC Criteria: October 28, 2019
• First Posted (Actual): October 30, 2019

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: HREBA.CC-19-0354

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No