OMENS: Effect of Omega 3 Enriched Oral Nutritional Supplement on Nutritional Status of CRC and NSCLC Patients
Study Details
Study Description
Brief Summary
A single arm intervention study examining the effect of an omega 3 enriched oral nutritional supplement on nutritional status of CRC and NSCLC patients
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm 1 twice daily serving of the study product |
Dietary Supplement: Oral Nutritional Supplement
twice daily serving of the study product
|
Outcome Measures
Primary Outcome Measures
- 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
- 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]
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Universitair Ziekenhuis Brussel | Brussels | Belgium | ||
| 2 | AZ Delta | Roeselare | Belgium | ||
| 3 | Cork University Hospital | Cork | Ireland |
Sponsors and Collaborators
- Nutricia Research
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SBB20R&35115