NCT04144907

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for not_applicable colorectal-cancer

Timeline
53mo left

Started Apr 2021

Longer than P75 for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress54%
Apr 2021Sep 2030

First Submitted

Initial submission to the registry

October 28, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 30, 2019

Completed
1.5 years until next milestone

Study Start

First participant enrolled

April 26, 2021

Completed
9.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2030

Last Updated

May 12, 2026

Status Verified

May 1, 2026

Enrollment Period

9.4 years

First QC Date

October 28, 2019

Last Update Submit

May 7, 2026

Conditions

Colorectal CancerBreast Cancer

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Phenylalanine intake

EXPERIMENTAL
Dietary Supplement: Phenylalanine intake

Interventions

Phenylalanine intakeDIETARY_SUPPLEMENT

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.

Phenylalanine intake

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2R3, Canada

RECRUITING

MeSH Terms

Conditions

Colorectal NeoplasmsBreast Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Carla Prado, PhD, RD

    University of Alberta

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne Caretero, RD

CONTACT

780-492-7820caretero@ualberta.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2019

First Posted

October 30, 2019

Study Start

April 26, 2021

Primary Completion (Estimated)

September 30, 2030

Study Completion (Estimated)

September 30, 2030

Last Updated

May 12, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)