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Protein Needs Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04144907
Recruitment Status : Recruiting
First Posted : October 30, 2019
Last Update Posted : March 1, 2023
Sponsor:
Information provided by (Responsible Party):
University of Alberta

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Breast Cancer Dietary Supplement: Phenylalanine intake Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Innovative Approaches to the Lack of Evidence-based Dietary Protein Requirements for Patients With Cancer
Actual Study Start Date : April 26, 2021
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04144907


Contacts
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Contact: Anne Caretero, RD 780-492-7820 caretero@ualberta.ca

Locations
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Canada, Alberta
University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G 2R3
Contact: Anne Caretero, RD    780-492-7820    caretero@ualberta.ca   
Sponsors and Collaborators
University of Alberta
Investigators
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Principal Investigator: Carla Prado, PhD, RD University of Alberta
More Information
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Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT04144907    
Other Study ID Numbers: HREBA.CC-19-0354
First Posted: October 30, 2019    Key Record Dates
Last Update Posted: March 1, 2023
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases