Clinical trial Recruiting at 1 site Interventional Ages 45 to 80

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 typeInterventional
Ages45 Years to 80 Years
SexAll
Enrollment40 (estimated)
SponsorUniversity of Alberta
Academic / other
Drugs / interventionschemotherapy, immunotherapy
Locations1 site (Edmonton, Alberta)
StatusRecruiting
StartedApril 26, 2021
Main results expectedSeptember 30, 2030
Study endsSeptember 30, 2030
Registry record updatedOctober 27, 2026
Trial IDNCT04144907 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

  • University of Alberta
    Edmonton, Alberta, Canada
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.