CancerNCT05859100
Can Protein Intake be Increased Using Whole Foods Post-treatment in Cancer Patients?
A study testing ≥ 2 eggs in addition to usual diet for 8 weeks and ≥ 2 eggs in addition to usual diet for 4 weeks in people with Cancer and Other Malnutrition, run by University of Alberta at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Other Malnutrition
- What is being tested?
- ≥ 2 eggs in addition to usual diet for 8 weeks and ≥ 2 eggs in addition to usual diet for 4 weeks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2023to 15 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- ≥ 2 eggs in addition to usual diet for 8 weeks, ≥ 2 eggs in addition to usual diet for 4 weeks
- Keywords
- Cancer, Nutrition, Protein, post-chemotherapy, Recovery, food-related quality of life
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
≥ 2 eggs in addition to usual diet for 8 weeksOther
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 weeksOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Early Intervention | Experimental | Participants are expected to begin intervention immediately after the completion of treatment for a period of 8 weeks. Receives: Other: ≥ 2 eggs in addition to usual diet for 8 weeks |
| Delayed Intervention | Other | Participants are expected to begin intervention 4 weeks after the completion of the treatment, for a period of 4 weeks (weeks 5-8). Receives: Other: ≥ 2 eggs in addition to usual diet for 4 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: From baseline at 8 weeks
Secondary outcomes (6)
Change in Energy Intake
Energy intake can be described as energy intake in kilocalories normalized by body weight in kilograms.
Measured: From baseline at 8 weeks
Change in Body weight
in kilograms
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: From baseline at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2023
- Study start1 Sep 2023
- Primary completion15 Jun 2025
- Study completion15 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of the two parallel arms (i.e., egg intervention arm and no intervention arm) for the first 4 weeks. Starting from week 5, the participants in the egg intervention arm will continue with the intervention till week 8 and the participants in the control arm will crossover to the intervention arm for weeks 5 to 8.
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Egg Farmers of Canada
- Responsible party
- Sponsor
- Investigators
- Vera Mazurak, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05859100
- Sponsor's protocol ID
- HREBA.CC-22-0348
- Status last verified
- Nov 2025
- First submitted
- 13 Apr 2023
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Protein Intake be Increased Using Whole Foods Post-treatment in Cancer Patients?
- ClinicalTrials.gov ID
- NCT05859100
- Acronym / sponsor ID
- HREBA.CC-22-0348
- Conditions
- Cancer, Other Malnutrition
- Keywords
- Cancer, Nutrition, Protein, post-chemotherapy, Recovery, food-related quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Egg Farmers of Canada
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 15 Jun 2025 (actual)
- Study completion
- 15 Jun 2025 (actual)
- First posted
- 15 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of the two parallel arms (i.e., egg intervention arm and no intervention arm) for the first 4 weeks. Starting from week 5, the participants in the egg intervention arm will continue with the intervention till week 8 and the participants in the control arm will crossover to the intervention arm for weeks 5 to 8.
| Arm | Type | Receives |
|---|---|---|
| Early Intervention | Experimental | Other: ≥ 2 eggs in addition to usual diet for 8 weeksParticipants are expected to begin intervention immediately after the completion of treatment for a period of 8 weeks. |
| Delayed Intervention | Other | Other: ≥ 2 eggs in addition to usual diet for 4 weeksParticipants are expected to begin intervention 4 weeks after the completion of the treatment, for a period of 4 weeks (weeks 5-8). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ≥ 2 eggs in addition to usual diet for 8 weeksParticipants 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 | Early Intervention |
| ≥ 2 eggs in addition to usual diet for 4 weeksParticipants 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. | Other | Delayed Intervention |
Primary outcome
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
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
6 secondary outcomes
Change in Energy Intake
Time frame: From baseline at 8 weeks
Change in Body weight
Time frame: From baseline at 8 weeks
Change in Quality of Life
Time frame: From baseline at 8 weeks
Change in Nutritional status and Symptom severity.
Time frame: From baseline at 8 weeks
Change in Quality of Life related to malnutrition
Time frame: From baseline at 8 weeks
Change in Physical performance
Time frame: From baseline at 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vera Mazurak, PhD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ≥ 2 eggs in addition to usual diet for 8 weeks and ≥ 2 eggs in addition to usual diet for 4 weeks in people with Cancer and Other Malnutrition, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in mean cumulative protein intake between the two groups at 8 weeks. (time frame: From baseline at 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.