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

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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

  • 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

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

Trial contacts and locations

0

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Central trial contact

Danone Nutricia Research

Data sourced from clinicaltrials.gov

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