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

Study Overview
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Brief Summary
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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.

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

Conditions
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Other Malnutrition, Cancer

Intervention / Treatment
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* Other: ≥ 2 eggs in addition to usual diet for 8 weeks
* Other: ≥ 2 eggs in addition to usual diet for 4 weeks


Participation Criteria
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Eligibility Criteria
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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.)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early Intervention<br>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<br>* 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.<br>|
| Other: Delayed Intervention<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Nutrition, Protein, post-chemotherapy, Recovery, food-related quality of life