Determining protein needs for cancer patients
Official title: Innovative Approaches to the Lack of Evidence-based Dietary Protein Requirements for Patients With Cancer
Run by University of Alberta · NCT04144907 · Data updated 2026-11-12
This study is testing how much protein cancer patients with colorectal or breast cancer need to help them stay healthy during treatment.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 45 Years to 80 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | University of Alberta Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Edmonton, Alberta) |
| Status | Recruiting |
| Started | April 26, 2021 |
| Main results expected | September 30, 2030 |
| Study ends | September 30, 2030 |
| Registry record updated | October 27, 2026 |
| Trial ID | NCT04144907 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are outpatients aged 45-80 with a diagnosis of stage II to III colorectal or breast cancer.
✕Probably not a fit
Patients who are premenopausal women or those with renal impairment or significant comorbidities may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to identify the specific protein requirements of patients diagnosed with colorectal or breast cancer, as severe muscle loss in these patients can lead to various health complications. Using a novel, non-invasive method, the research will assess protein needs to inform better nutritional guidelines. The ultimate goal is to enhance patient outcomes by ensuring adequate protein intake during treatment. Participants will be outpatients aged 45-80 who are able to complete baseline visits around the start of chemotherapy or post-surgery.
Why it matters
Potential benefit: If successful, this study could lead to improved nutritional recommendations that enhance the health and recovery of cancer patients.
How similar studies have gone: While this approach is novel, similar studies have indicated the importance of tailored nutritional interventions in cancer care.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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University of Alberta
Edmonton, Alberta, Canada Recruiting
Study contacts
- Principal investigator: Carla Prado, PhD, RD — University of Alberta
- Study coordinator: Barbara Chaves Santos, PhD
- Email: barbara.santos@ualberta.ca
- Phone: 780-492-7820
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.