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

NCT05495360 | Completed

• 1 other identifier: SBB20R&35115
• Study Type: interventional
• Target: 48
• Locations: 3 countries
• Sites: 5

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

Keywords

Oral nutritional supplement; Oncology; Omega 3

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

Study Arms (1)

Arm 1

EXPERIMENTAL

twice daily serving of the study product

Dietary Supplement: Oral Nutritional Supplement

Interventions

Oral Nutritional Supplement DIETARY_SUPPLEMENT

twice daily serving of the study product

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nutricia Research: lead

Study Sites (5)

Universitair Ziekenhuis Brussel

Brussels, Belgium

Location

AZ Delta

Roeselare, Belgium

Location

Faculty Hospital Brno

Brno, Czechia

Location

Fakultní nemocnice Bulovka

Prague, Czechia

Location

Cork University Hospital

Cork, Ireland

Location

MeSH Terms

Conditions

Malnutrition; Neoplasms

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2022
• First Posted: August 10, 2022
• Study Start: January 17, 2023
• Primary Completion: September 2, 2024
• Study Completion: September 2, 2024
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (2); IE (1); BE (2)