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

Phase

N/A

Condition

Weight Loss

Diet And Nutrition

Neoplasms

Treatment

≥ 2 eggs in addition to usual diet for 4 weeks

≥ 2 eggs in addition to usual diet for 8 weeks

Clinical Study ID

NCT05859100

HREBA.CC-22-0348

Ages > 18
All Genders

Study 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

Inclusion Criteria:

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

Exclusion

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 toconsume food.
A known hypersensitivity / allergy to eggs.
Enrolment in any other clinical protocol or investigational study that may interferewith study procedures.
Poorly controlled chronic illnesses or other inflammatory diseases (e.g. ChronicObstructive Pulmonary Disease(COPD), uncontrolled non-insulin dependent diabetes,rheumatoid arthritis).
In a clinician opinion, patients who have medical conditions that could interferewith nutrient metabolism or absorption (e.g., short bowel syndrome, Crohn's disease,etc.)

Study Design