| NCT ID | NCT04144907 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Alberta |
| Condition | Colorectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2021-04-26 |
| Primary Completion | 2030-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2021-04-26 with a primary completion date of 2030-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Carla Prado, PhD, RD
PRINCIPAL INVESTIGATOR
University of Alberta
Frequently Asked Questions
Who can join the NCT04144907 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, up to 80 Years, studying Colorectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04144907 currently recruiting?
Yes, NCT04144907 is actively recruiting participants. Contact the research team at caretero@ualberta.ca for enrollment information.
Where is the NCT04144907 trial being conducted?
This trial is being conducted at Edmonton, Canada.
Who is sponsoring the NCT04144907 clinical trial?
NCT04144907 is sponsored by University of Alberta. The principal investigator is Carla Prado, PhD, RD at University of Alberta. The trial plans to enroll 40 participants.
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