Effect of Omega 3 Enriched Oral Nutritional Supplement on Nutritional Status of CRC and NSCLC Patients

Study Overview
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Brief Summary
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A single arm intervention study examining the effect of an omega 3 enriched oral nutritional supplement on nutritional status of CRC and NSCLC patients

Official Title
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Effect of Omega 3 Enriched Oral Nutritional Supplement on Nutritional Status of CRC and NSCLC Patients

Conditions
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Oncology, Malnutrition

Intervention / Treatment
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* Dietary Supplement: Oral Nutritional Supplement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically proven CRC or histologically or cytologically proven NSCLC Eligible and scheduled for at least 2 cycles of 4-week cycles of systemic treatment, 3 cycles of 3-week cycles of systemic treatment or 4 cycles of 2-week cycles of systemic treatment At risk of malnutrition or malnourished [PG-SGA-SF > 4] Performance status ECOG 0 or 1 Weight loss grade 0-3 according to Martin et al1 <11% weight loss in the past 6 months Age ≥ 18 years Written informed consent Exclusion Criteria: Presence of ileostoma or ileal pouch GI-related or major surgery in 30 days prior to baseline Severe hypercalcemia, i.e. total calcium level, corrected for albumin ≥ 14.0 mg/dL (3.5 mmol/L) Use of ONS, enteral nutrition or parenteral nutrition within 14 days prior to entry into the study Use of fish oil containing supplements, within 30 days prior to entry into the study or expected to use this during the study Use of more than 200 iU/day of vitamin D containing supplements within 30 days prior to entry into the study or expected to use this during the study Life expectancy of < 3 months Severe renal dysfunction (<29 ml/min/1.73m2 eGRF or albumin:creatinine (ACR) > 30) or hepatic encephalopathy Allergy to cow's milk protein or fish, known protein sensitivity or suffering galactosemia Known pregnancy or lactation Current alcohol or drug abuse in opinion of the investigator Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>twice daily serving of the study product | Dietary Supplement: Oral Nutritional Supplement<br>* twice daily serving of the study product<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in EPA concentration in the phospholipid fraction of the erythrocyte membrane [% of total fatty acids] |  | at end of first in-study treatment cycle compared to baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in protein intake [g/day] [key secondary outcome) |  | at end of first in-study treatment cycle compared to baseline | 
| Change in protein intake [g/kg bw/day] [key secondary outcome) |  | at end of first in-study treatment cycle compared to baseline | 
| Change in energy intake [kcal/day] |  | at end of first in-study treatment cycle compared to baseline | 
| Change in energy intake [kcal/kg bw/day] |  | at end of first in-study treatment cycle compared to baseline | 
| Provided vitamin D supplementation [µg/day] by the test product |  | Throughout total intervention period - about 2 months | 
| Change in fatty acid profile in the phospholipid fraction of the cell membrane of erythrocytes [% of total fatty acids] |  | at end of first in-study treatment cycle compared to baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oral nutritional supplement, Oncology, Omega 3