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CompletedNCT05859100Updated Nov 18, 2025

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

An interventional study of ≥ 2 eggs in addition to usual diet for 8 weeks and ≥ 2 eggs in addition to usual diet for 4 weeks in Cancer and Other Malnutrition, sponsored by University of Alberta. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-18.

Sponsored by University of Alberta · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
2
Allocation
Randomized
Ages
18 Years and older
Sex
All
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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.

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Conditions studied

  • Cancer
  • Other Malnutrition

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Keywords

  • Cancer
  • Nutrition
  • Protein
  • post-chemotherapy
  • Recovery
  • food-related quality of life
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In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 2 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.

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Lead sponsor

University of Alberta is the lead sponsor of 800 studies on the registry; 168 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.)
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
2 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • 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.

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What researchers measure

Primary outcomes

  1. 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

    Time frame: From baseline at 8 weeks

  2. 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

    Time frame: From baseline at 8 weeks

Secondary outcomes

  1. Change in Energy Intake

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

    Time frame: From baseline at 8 weeks

  2. Change in Body weight

    in kilograms

    Time frame: From baseline at 8 weeks

  3. 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.

    Time frame: From baseline at 8 weeks

  4. 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)

    Time frame: From baseline at 8 weeks

  5. 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)

    Time frame: From baseline at 8 weeks

  6. Change in Physical performance

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

    Time frame: From baseline at 8 weeks

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Study locations

1 site
  • University of Alberta
    Edmonton, Alberta T6G 2C8, Canada
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05859100
Lead sponsor
University of Alberta
Collaborators
Egg Farmers of Canada
Responsible party
Sponsor
First posted
May 15, 2023
Start date
Sep 1, 2023
Primary completion
Jun 15, 2025
Completion
Jun 15, 2025
Last update
Nov 18, 2025

Study contacts

Vera Mazurak, PhD
principal investigator · University of Alberta

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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