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Clinical Trials/NCT05495360
NCT05495360CompletedNot Applicable

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

Nutricia Research5 sites in 3 countries48 target enrollmentStarted: January 17, 2023Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
48
Locations
5
Primary Endpoint
Change in EPA concentration in the phospholipid fraction of the erythrocyte membrane [% of total fatty acids]
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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

Arms & Interventions

Arm 1

Experimental

twice daily serving of the study product

Intervention: Oral Nutritional Supplement (Dietary Supplement)

Outcomes

Primary Outcomes

Change in EPA concentration in the phospholipid fraction of the erythrocyte membrane [% of total fatty acids]

Time Frame: at end of first in-study treatment cycle compared to baseline

Secondary Outcomes

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

Investigators

Sponsor
Nutricia Research
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (5)

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