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Protein Needs Study

Primary Purpose

Colorectal Cancer, Breast Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Phenylalanine intake
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Colorectal Cancer

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • University of AlbertaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Phenylalanine intake

Arm Description

Outcomes

Primary Outcome Measures

13C Phenylalanine Oxidation
Breath, urine and blood samples will be collected during the study to measure the rate of oxidation of 13C phenylalanine.

Secondary Outcome Measures

Full Information

First Posted
October 28, 2019
Last Updated
February 27, 2023
Sponsor
University of Alberta
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1. Study Identification

Unique Protocol Identification Number
NCT04144907
Brief Title
Protein Needs Study
Official Title
Innovative Approaches to the Lack of Evidence-based Dietary Protein Requirements for Patients With Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 26, 2021 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Breast Cancer

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Phenylalanine intake
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Phenylalanine intake
Intervention Description
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.
Primary Outcome Measure Information:
Title
13C Phenylalanine Oxidation
Description
Breath, urine and blood samples will be collected during the study to measure the rate of oxidation of 13C phenylalanine.
Time Frame
8.5 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne Caretero, RD
Phone
780-492-7820
Email
caretero@ualberta.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carla Prado, PhD, RD
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2R3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Caretero, RD
Phone
780-492-7820
Email
caretero@ualberta.ca

12. IPD Sharing Statement

Plan to Share IPD
No

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Protein Needs Study

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