Clinical Trial Finder
Effect of Omega 3 Enriched Oral Nutritional Supplement on Nutritional Status of CRC and NSCLC Patients
Study Purpose
A single arm intervention study examining the effect of an omega 3 enriched oral nutritional supplement on nutritional status of CRC and NSCLC patients
Recruitment Criteria
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
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 studyTrial Details
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
Arms
Experimental: Arm 1
twice daily serving of the study product
Interventions
Dietary Supplement: - Oral Nutritional Supplement
twice daily serving of the study product
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
International Sites
Status
Not yet recruiting
Address
Universitair Ziekenhuis Brussel
Brussels, ,
Site Contact
[email protected]
+31 30 2095 000
Status
Not yet recruiting
Address
AZ Delta
Roeselare, ,
Site Contact
[email protected]
+31 30 2095 000
Status
Not yet recruiting
Address
Faculty Hospital Brno
Brno, ,
Site Contact
[email protected]
+31 30 2095 000
Status
Not yet recruiting
Address
Fakultní nemocnice Bulovka
Praha, ,
Site Contact
[email protected]
+31 30 2095 000
Status
Recruiting
Address
Cork University Hospital
Cork, ,
Site Contact
[email protected]
+31 30 2095 000
Privacy Overview