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

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.

Study Overview

• Status: Completed
• Conditions: Cancer; Other Malnutrition
• Intervention / Treatment: Other: ≥ 2 eggs in addition to usual diet for 8 weeks; Other: ≥ 2 eggs in addition to usual diet for 4 weeks

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2C8
      • University of Alberta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early Intervention; Participants are expected to begin intervention immediately after the completion of treatment for a period of 8 weeks.	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: Delayed Intervention; Participants are expected to begin intervention 4 weeks after the completion of the treatment, for a period of 4 weeks (weeks 5-8).	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in mean cumulative protein intake between the two groups at 8 weeks.	Mean cumulative protein intake will be arrived at by normalizing protein intake in kilocalories by body weight in kilograms	From baseline at 8 weeks
Difference in mean cumulative protein intake within a group at 8 weeks for each group.	Mean cumulative protein intake will be arrived at by normalizing protein intake in kilocalories by body weight in kilograms	From baseline at 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Energy Intake	Energy intake can be described as energy intake in kilocalories normalized by body weight in kilograms.	From baseline at 8 weeks
Change in Body weight	in kilograms	From baseline at 8 weeks
Change in Quality of Life	Research and Development(RAND) Short Form 36-Item Health Survey 1.0 Minimum to Maximum score= 0 to 100 High Score indicates more favorable outcome.	From baseline at 8 weeks
Change in Nutritional status and Symptom severity.	Patient generated-subjective global assessment (PG-SGA), 0-9 point score, higher the score more severe the malnourishment. Edmonton Symptom Assessment Scale- Revised (ESAS-r, 0 to 10 Visual analog scale, higher the number more severe the symptom)	From baseline at 8 weeks
Change in Quality of Life related to malnutrition	Functional assessment of Anorexia-Cachexia Therapy 5 question Anorexia/ Cachexia subscale (FAACT A/C Subscale, Score Range= 0 to 20, Higher the score better the quality of life)	From baseline at 8 weeks
Change in Physical performance	Short physical performance battery (SPPB, Score range= 0 to 12, higher the score better the performance)	From baseline at 8 weeks

Collaborators and Investigators

• Sponsor: University of Alberta
• Collaborators: Egg Farmers of Canada
• Investigators: Principal Investigator: Vera Mazurak, PhD, University of Alberta

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Actual): June 15, 2025
• Study Completion (Actual): June 15, 2025

Study Registration Dates

• First Submitted: April 13, 2023
• First Submitted That Met QC Criteria: May 11, 2023
• First Posted (Actual): May 15, 2023

Study Record Updates

• Last Update Posted (Estimated): November 18, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Cancer; Recovery; Nutrition; Protein; post-chemotherapy; food-related quality of life
• Additional Relevant MeSH Terms: Nutrition Disorders; Neoplasms
• Other Study ID Numbers: HREBA.CC-22-0348

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No