NCT05859100

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: University of Alberta · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer
• Other Malnutrition

Interventions

Type	Name	Description
OTHER	≥ 2 eggs in addition to usual diet for 8 weeks	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.
OTHER	≥ 2 eggs in addition to usual diet for 4 weeks	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.

Timeline

• Start date: 2023-09-01
• Primary completion: 2025-06-15
• Completion: 2025-06-15
• First posted: 2023-05-15
• Last updated: 2025-11-18

Locations

1 site across 1 country: Canada