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

Malnutrition Clinical Trial

— OMENS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05495360
• Other study ID #: SBB20R&35115
• Status: Recruiting
• Phase: N/A
• Start date: January 17, 2023
• Est. completion date: December 2023

Study information

• Verified date: January 2023
• Source: Nutricia Research
• Contact: Danone Nutricia Research
• Phone: +31 30 2095 000
• Email: register.clinicalresearchnutricia[@]danone.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Histologically proven CRC or histologically or cytologically proven NSCLC

2. 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

3. At risk of malnutrition or malnourished [PG-SGA-SF > 4]

4. Performance status ECOG 0 or 1

5. Weight loss grade 0-3 according to Martin et al1

6. <11% weight loss in the past 6 months

7. Age = 18 years

8. Written informed consent

Exclusion Criteria:

1. Presence of ileostoma or ileal pouch

2. GI-related or major surgery in 30 days prior to baseline

3. Severe hypercalcemia, i.e. total calcium level, corrected for albumin = 14.0 mg/dL (3.5 mmol/L)

4. Use of ONS, enteral nutrition or parenteral nutrition within 14 days prior to entry into the study

5. Use of fish oil containing supplements, within 30 days prior to entry into the study or expected to use this during the study

6. 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

7. Life expectancy of < 3 months

8. Severe renal dysfunction (<29 ml/min/1.73m2 eGRF or albumin:creatinine (ACR) > 30) or hepatic encephalopathy

9. Allergy to cow's milk protein or fish, known protein sensitivity or suffering galactosemia

10. Known pregnancy or lactation

11. Current alcohol or drug abuse in opinion of the investigator

12. Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements

13. Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study

Related Conditions & MeSH terms

• Malnutrition
• Oncology

Intervention

Dietary Supplement:
• Oral Nutritional Supplement
twice daily serving of the study product

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Brussel	Brussels
Belgium	AZ Delta	Roeselare
Czechia	Faculty Hospital Brno	Brno
Czechia	Fakultní nemocnice Bulovka	Praha
Ireland	Cork University Hospital	Cork

Sponsors (1)

Lead Sponsor	Collaborator
Nutricia Research

Countries where clinical trial is conducted

Belgium,  Czechia,  Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in protein intake [g/day] [key secondary outcome)		at end of first in-study treatment cycle compared to baseline
Secondary	Change in protein intake [g/kg bw/day] [key secondary outcome)		at end of first in-study treatment cycle compared to baseline
Secondary	Change in energy intake [kcal/day]		at end of first in-study treatment cycle compared to baseline
Secondary	Change in energy intake [kcal/kg bw/day]		at end of first in-study treatment cycle compared to baseline
Secondary	Provided vitamin D supplementation [µg/day] by the test product		Throughout total intervention period - about 2 months
Secondary	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