Protein Needs Study

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04144907
• Other study ID #: HREBA.CC-19-0354
• Status: Recruiting
• Phase: N/A
• Start date: April 26, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: November 2023
• Source: University of Alberta
• Contact: Anne Caretero, RD
• Phone: 780-492-7820
• Email: caretero[@]ualberta.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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