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

NCT ID: NCT05495360

Last Updated: 2025-02-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-17
• Study Completion Date: 2024-09-02

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

Conditions

Malnutrition; Oncology

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Arm 1

twice daily serving of the study product

Group Type: EXPERIMENTAL

Oral Nutritional Supplement

Intervention Type: DIETARY_SUPPLEMENT

twice daily serving of the study product

Interventions

Oral Nutritional Supplement

twice daily serving of the study product

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nutricia Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Universitair Ziekenhuis Brussel

Brussels, , Belgium

AZ Delta

Roeselare, , Belgium

Faculty Hospital Brno

Brno, , Czechia

Fakultní nemocnice Bulovka

Prague, , Czechia

Cork University Hospital

Cork, , Ireland

Countries

Belgium; Czechia; Ireland

Other Identifiers

SBB20R&35115

Identifier Type: -

Identifier Source: org_study_id