Clinical trial · Interventional
Effect of Omega 3 Enriched Oral Nutritional Supplement on Nutritional Status of CRC and NSCLC Patients
NCT05495360CI-TRIAL-00086192OMENScompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malnutrition | — | UNRESOLVED | — |
| Oncology | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oral Nutritional Supplement | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm 1
- description
- twice daily serving of the study product
- interventionNames
- Dietary Supplement: Oral Nutritional Supplement
Primary outcomes (1)
- measure
- Change in EPA concentration in the phospholipid fraction of the erythrocyte membrane [% of total fatty acids]
- timeFrame
- at end of first in-study treatment cycle compared to baseline
Secondary outcomes (6)
- measure
- Change in protein intake [g/day] [key secondary outcome)
- timeFrame
- at end of first in-study treatment cycle compared to baseline
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.