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

NCT ID: NCT05859100

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2025-06-15

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.

Conditions

Cancer; Other Malnutrition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Early Intervention

Participants are expected to begin intervention immediately after the completion of treatment for a period of 8 weeks.

Group Type: EXPERIMENTAL

≥ 2 eggs in addition to usual diet for 8 weeks

Intervention Type: OTHER

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.

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).

Group Type: OTHER

≥ 2 eggs in addition to usual diet for 4 weeks

Intervention Type: OTHER

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.

Interventions

≥ 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.

Intervention Type: 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.

Intervention Type: OTHER

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.)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Egg Farmers of Canada

UNKNOWN

Sponsor Role: collaborator

University of Alberta

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vera Mazurak, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

University of Alberta

Edmonton, Alberta, Canada

Countries

Canada

Other Identifiers

HREBA.CC-22-0348

Identifier Type: -

Identifier Source: org_study_id