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Completed

NCT Number: NCT05859100

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.

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Key information

Conditions

Cancer Neoplasms Other Malnutrition

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alberta

Edmonton, Alberta, T6G 2C8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

≥ 2 eggs in addition to usual diet for 8 weeks

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.

≥ 2 eggs in addition to usual diet for 4 weeks

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.

Primary outcomes

  1. Difference in mean cumulative protein intake between the two groups at 8 weeks.

    Time frame: From baseline at 8 weeks

    Mean cumulative protein intake will be arrived at by normalizing protein intake in kilocalories by body weight in kilograms

  2. Difference in mean cumulative protein intake within a group at 8 weeks for each group.

    Time frame: From baseline at 8 weeks

    Mean cumulative protein intake will be arrived at by normalizing protein intake in kilocalories by body weight in kilograms

Secondary outcomes

  1. Change in Energy Intake

    Time frame: From baseline at 8 weeks

    Energy intake can be described as energy intake in kilocalories normalized by body weight in kilograms.

  2. Change in Body weight

    Time frame: From baseline at 8 weeks

    in kilograms

  3. Change in Quality of Life

    Time frame: From baseline at 8 weeks

    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.

  4. Change in Nutritional status and Symptom severity.

    Time frame: From baseline at 8 weeks

    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)

  5. Change in Quality of Life related to malnutrition

    Time frame: From baseline at 8 weeks

    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)

  6. Change in Physical performance

    Time frame: From baseline at 8 weeks

    Short physical performance battery (SPPB, Score range= 0 to 12, higher the score better the performance)

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • Egg Farmers of Canada

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 15, 2023
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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