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| Name | Class |
|---|---|
| San Luigi Gonzaga Hospital | OTHER |
| Azienda Ospedaliera Universitaria Integrata Verona | OTHER |
| Humanitas Hospital, Italy | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immunonutrition | Experimental | 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 |
|
| Control dietary intervention | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immunonutrition | Dietary Supplement | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | A progression-free survival rate at 12 months will be calculated, with patients categorized in a dichotomous manner as alive and progression-free or in progression or dead at 12 months. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of response | Time to progression | 24 months |
| Overall survival | Overall survival | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Serum levels of immunologic markers | Change in levels of soluble effectors and immuno-regulatory cells during the study by cytofluorimetry and validated biochemical assays | 12 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Riccardo Caccialanza, MD | Contact | 0382501615 | 0039 | r.caccialanza@smatteo.pv.it |
| Alessandra Ferrari, PharmD | Contact | 0382503689 | 0039 | alessandra.ferrari@smatteo.pv.it |
| Name | Affiliation | Role |
|---|---|---|
| Riccardo Caccialanza, MD | Fondazione IRCCS Policlinico San Matteo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione IRCCS Policlinico San Matteo | Recruiting | Pavia | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36434615 | Derived | Caccialanza R, Cereda E, Agustoni F, Klersy C, Casirati A, Montagna E, Carnio S, Novello S, Milella M, Pilotto S, Trestini I, Buffoni L, Ferrari A, Pedrazzoli P. Multicentre, randomised, open-label, parallel-group, clinical phase II study to evaluate immunonutrition in improving efficacy of immunotherapy in patients with metastatic non-small cell lung cancer, undergoing systematic nutritional counseling. BMC Cancer. 2022 Nov 24;22(1):1212. doi: 10.1186/s12885-022-10296-x. |
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Depending on a specific research question and according to a study protocol to be approved by the Ethics Committee
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D000093702 | Immunonutrition Diet |
| ID | Term |
|---|---|
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Control dietary intervention | Other | 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. |
|
| Treatment-related moderate-severe adverse events as assessed by Common Terminology Criteria for Adverse Events [CTCAE v5.0] | Difference in the incidence of grade >=3 toxicity, according to CTCAE v5.0 | 4 months |
| Skeletal muscle mass | Change in skeletal muscle mass during the study evaluated with bioimpedance vectorial analysis and computed tomography scans | 12 months |
| Fatigue | Change in fatigue during the study as assessed by the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) questionnaire | 12 months |
| Self-perceived quality of life | Change in quality of life during the study as assessed by validated questionnaires | 12 months |
| Self-reported physical activity level | Change in self-reported physical activity level as assessed by the Godin's Shepard Leisure Time Exercise Questionnaire | 12 months |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |