To hear about similar clinical trials, please enter your email below
Trial Title:
Effect of Omega 3 Enriched Oral Nutritional Supplement on Nutritional Status of CRC and NSCLC Patients
NCT ID:
NCT05495360
Condition:
Malnutrition
Oncology
Conditions: Official terms:
Malnutrition
Conditions: Keywords:
Oral nutritional supplement
Oncology
Omega 3
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Dietary Supplement
Intervention name:
Oral Nutritional Supplement
Description:
twice daily serving of the study product
Arm group label:
Arm 1
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
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Universitair Ziekenhuis Brussel
Address:
City:
Brussels
Country:
Belgium
Status:
Not yet recruiting
Facility:
Name:
AZ Delta
Address:
City:
Roeselare
Country:
Belgium
Status:
Not yet recruiting
Facility:
Name:
Faculty Hospital Brno
Address:
City:
Brno
Country:
Czechia
Status:
Not yet recruiting
Facility:
Name:
Fakultní nemocnice Bulovka
Address:
City:
Praha
Country:
Czechia
Status:
Not yet recruiting
Facility:
Name:
Cork University Hospital
Address:
City:
Cork
Country:
Ireland
Status:
Recruiting
Start date:
January 17, 2023
Completion date:
December 2023
Lead sponsor:
Agency:
Nutricia Research
Agency class:
Industry
Source:
Nutricia Research
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05495360
