Clinical trial NCT05495360: Effect of Omega 3 Enriched Oral Nutritional Supplement on Nutritional Status of CRC and NSCLC Patients
Official title: Effect of Omega 3 Enriched Oral Nutritional Supplement on Nutritional Status of CRC and NSCLC Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Oncology
Keywords: Oral nutritional supplement
Oncology
Omega 3
Lead sponsor: Nutricia Research
Sponsor class: INDUSTRY
First posted: 2022-08-10
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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


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

Primary outcomes:
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:
measure: Change in protein intake [g/day] [key secondary outcome)
timeFrame: at end of first in-study treatment cycle compared to baseline
measure: Change in protein intake [g/kg bw/day] [key secondary outcome)
timeFrame: at end of first in-study treatment cycle compared to baseline
measure: Change in energy intake [kcal/day]
timeFrame: at end of first in-study treatment cycle compared to baseline
measure: Change in energy intake [kcal/kg bw/day]
timeFrame: at end of first in-study treatment cycle compared to baseline
measure: Provided vitamin D supplementation [µg/day] by the test product
timeFrame: Throughout total intervention period - about 2 months
measure: Change in fatty acid profile in the phospholipid fraction of the cell membrane of erythrocytes [% of total fatty acids]
timeFrame: at end of first in-study treatment cycle compared to baseline
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Universitair Ziekenhuis Brussel
city: Roeselare
country: Belgium
facility: AZ Delta
city: Brno
country: Czechia
facility: Faculty Hospital Brno
city: Praha
country: Czechia
facility: Fakultní nemocnice Bulovka
city: Cork
country: Ireland
facility: Cork University Hospital
Study officials:
References: