Can Protein Intake be Increased Using Whole Foods Post-treatment in Cancer Patients?

Trial Title: Can Protein Intake be Increased Using Whole Foods Post-treatment in Cancer Patients?

NCT ID: NCT05859100

Condition: Cancer
Other Malnutrition

Conditions: Official terms:
Malnutrition

Conditions: Keywords:
Cancer
Nutrition
Protein
post-chemotherapy
Recovery
food-related quality of life

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

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

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: ≥ 2 eggs in addition to usual diet for 8 weeks
Description: Participants are expected to consume≥ 2 eggs per day in addition to usual diet for 8 weeks in early intervention arm, beginning immediately post-treatment.
Arm group label: Early Intervention

Intervention type: Other
Intervention name: ≥ 2 eggs in addition to usual diet for 4 weeks
Description: Participants are expected to continue intake of regular diet beginning immediately at post-treatment recovery for a duration of 4 weeks, then crossover to nutritional intervention arm from weeks 5 to 8 of post-treatment recovery for a duration of 4 weeks.
Arm group label: Delayed Intervention

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.

Criteria for 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.)

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: University of Alberta

Address:
City: Edmonton
Zip: T6G 2C8
Country: Canada

Status: Recruiting

Start date: September 1, 2023

Completion date: April 2025

Lead sponsor:
Agency: University of Alberta
Agency class: Other

Collaborator:
Agency: Egg Farmers of Canada
Agency class: Other

Source: University of Alberta

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05859100