Trials / Recruiting
RecruitingNCT05384873
Immunonutrition for Improving the Efficacy of Immunotherapy in Patients With Metastatic Non-small Cell Lung Cancer
Multicentre, Randomised, Open-label, Parallel-group Trial to Evaluate Immunonutrition in Improving Efficacy of Immunotherapy in Patients With Metastatic Non-small Cell Lung Cancer, Undergoing Systematic Nutritional Counseling
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 180 (estimated)
- Sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The present study was designed to evaluate the efficacy of the early systematic provision of oral nutritional supplements enriched in immunonutrients in non-small lung cancer patients undergoing immunotherapy and receiving nutritional counseling
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Immunonutrition | In addition to nutritional counseling, patients will receive two servings of an oral high-calorie-high-protein nutritional liquid supplement enriched in immunonutrients (Oral Impact®). The intervention will start approximately two weeks before anticancer treatment initiation and will continue up to first disease re-assessment (12-14 weeks) and prolonged according to patient's needs |
| OTHER | Control dietary intervention | Patients will receive nutritional counseling as standard of care. Nutritional counseling may comprise the use of oral nutritional supplements (ONS), which are usually prescribed when patients are unable to maintain satisfactory spontaneous food intake (less than 50% of the requirement for more than one week or only 50-75% of the requirement for more than two weeks). Therefore, in this arm the use of isonitrogenous standard blend ONS will be considered according to the regular assessment of food intake. |
Timeline
- Start date
- 2023-06-01
- Primary completion
- 2026-07-31
- Completion
- 2027-07-31
- First posted
- 2022-05-20
- Last updated
- 2025-05-01
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT05384873. Inclusion in this directory is not an endorsement.