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

Nutricia

Status: Enrolling

Conditions: Oncology; Malnutrition

Treatments: Dietary Supplement: Oral Nutritional Supplement

Study type: Interventional

Funder types: Industry

Identifiers

NCT05495360

SBB20R&35115

Details and patient eligibility

About

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

Enrollment: 48 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

48 participants in 1 patient group

Arm 1

Experimental group

Description:

twice daily serving of the study product

Treatment:

Dietary Supplement: Oral Nutritional Supplement