Clinical trial NCT05859100: Can Protein Intake be Increased Using Whole Foods Post-treatment in Cancer Patients?
Official title: Can Protein Intake be Increased Using Whole Foods Post-treatment in Cancer Patients?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Other Malnutrition
Keywords: Cancer
Nutrition
Protein
post-chemotherapy
Recovery
food-related quality of life
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Egg Farmers of Canada
First posted: 2023-05-15
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to one of the two parallel arms (i.e., egg intervention arm and no intervention arm) for the first 4 weeks. Starting from week 5, the participants in the egg intervention arm will continue with the intervention till week 8 and the participants in the control arm will crossover to the intervention arm for weeks 5 to 8.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Cancer and its treatments often result in severe toxicities and side effects that, over the course of treatment, results in weight loss and depletion of key nutrients. Loss of muscle mass and strength during cancer treatment is a critical problem because it negatively affects patient response and tolerance to therapy and post-treatment recovery. To restore the nutritional status, it is imperative to stimulate muscle protein anabolism. Eggs are high quality protein source, popular and well tolerated by cancer patients. Therefore, the objective of this study is to determine whether a nutritional intervention of ≥2 eggs can aid in restoring nutritional status and improving immune function and quality of life of cancer patients' post-treatment. It is an 8- week randomised clinical trial with parallel arm assignment. Half of the participants will receive the nutritional intervention (Early Intervention) and the other half will be on standard of care or usual diet for first 4 weeks. Starting from week 5, all participants will receive the nutrition intervention till week 8 (Delayed Intervention). Dietary intake (foods and nutrients), cumulative protein intake (g protein/kg body weight), immunological measures, physical performance and quality of life has been planned to be assessed over time and between groups to evaluate the feasibility of an egg intervention in meeting recommended protein intakes for patients with cancer.


Eligibility criteria: Inclusion Criteria:

* Patients must have the ability to read, understand, and sign an informed consent and must be willing to comply with study treatment and follow-up.
* ≥18 years of age
* Histopathologically confirmed cancer with receipt of a platinum chemotherapy during treatment; active treatment has concluded.
* Capable of volitional oral semi-solid intake at baseline; able to maintain oral intake over the trial.

Exclusion Criteria:

* Fed by nasogastric tube, gastrostomy, or total parenteral nutrition
* Cancer of the brain, Cancer of the regions which impact an individual's ability to consume food.
* A known hypersensitivity / allergy to eggs.
* Enrolment in any other clinical protocol or investigational study that may interfere with study procedures.
* Poorly controlled chronic illnesses or other inflammatory diseases (e.g. Chronic Obstructive Pulmonary Disease(COPD), uncontrolled non-insulin dependent diabetes, rheumatoid arthritis).
* In a clinician opinion, patients who have medical conditions that could interfere with nutrient metabolism or absorption (e.g., short bowel syndrome, Crohn's disease, etc.)

Primary outcomes:
measure: Difference in mean cumulative protein intake between the two groups at 8 weeks.
timeFrame: From baseline at 8 weeks
measure: Difference in mean cumulative protein intake within a group at 8 weeks for each group.
timeFrame: From baseline at 8 weeks
Secondary outcomes:
measure: Change in Energy Intake
timeFrame: From baseline at 8 weeks
measure: Change in Body weight
timeFrame: From baseline at 8 weeks
measure: Change in Quality of Life
timeFrame: From baseline at 8 weeks
measure: Change in Nutritional status and Symptom severity.
timeFrame: From baseline at 8 weeks
measure: Change in Quality of Life related to malnutrition
timeFrame: From baseline at 8 weeks
measure: Change in Physical performance
timeFrame: From baseline at 8 weeks
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: University of Alberta
name: Vera Mazurak, PhD
role: PRINCIPAL_INVESTIGATOR
References: