Determining protein needs for cancer patients
Innovative Approaches to the Lack of Evidence-based Dietary Protein Requirements for Patients With Cancer
This study is testing how much protein cancer patients with colorectal or breast cancer need to help them stay healthy during treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 45 Years to 80 Years |
| Sex | All |
| Sponsor | University of Alberta Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Edmonton, Alberta) |
| Trial ID | NCT04144907 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are outpatients aged 45-80 with a diagnosis of stage II to III colorectal or breast cancer.
Not a fit: Patients who are premenopausal women or those with renal impairment or significant comorbidities may not benefit from this study.
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 performed: While this approach is novel, similar studies have indicated the importance of tailored nutritional interventions in cancer care.
Eligibility criteria
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 this trial is running
Edmonton, Alberta
- University of Alberta — Edmonton, Alberta, Canada (Recruiting)
Study contacts
- Principal investigator: Carla Prado, PhD, RD — University of Alberta
- Study coordinator: Anne Caretero, RD
- Email: caretero@ualberta.ca
- Phone: 780-492-7820
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.