Lung Cancer, Nonsmall Cell
Conditions
Brief 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
Interventions
DIETARY_SUPPLEMENTImmunonutrition
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
OTHERControl 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.
Sponsors
San Luigi Gonzaga Hospital
Azienda Ospedaliera Universitaria Integrata Verona
Humanitas Hospital, Italy
Fondazione IRCCS Policlinico San Matteo di Pavia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Confirmed histological diagnosis of metastatic non-small cell lung cancer (both squamous and non-squamous histology); * First-line treatment with immunotherapy (alone or in combination with chemotherapy) for metastatic disease by investigators' choice within the framework of good clinical practice and in agreement with current guidelines; * Will to participate by providing written informed consent; * Availability to administer oral supplements and immunotherapy with or without chemotherapy; * Eastern Cooperative Oncology Group Performance Status ≤ 2; * Life expectancy ≥ 6 months.
Exclusion criteria
* Age \< 18 years; * Inability to sign an informed consent; * Indication to or ongoing artificial nutrition support (totally compromised spontaneous food-intake) and incapacity or unavailability to consume oral nutritional supplements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) | 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of response | 24 months | Time to progression |
| Overall survival | 24 months | Overall survival |
| Treatment-related moderate-severe adverse events as assessed by Common Terminology Criteria for Adverse Events [CTCAE v5.0] | 4 months | Difference in the incidence of grade \>=3 toxicity, according to CTCAE v5.0 |
| Fatigue | 12 months | Change in fatigue during the study as assessed by the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) questionnaire |
| Self-perceived quality of life | 12 months | Change in quality of life during the study as assessed by validated questionnaires |
| Self-reported physical activity level | 12 months | Change in self-reported physical activity level as assessed by the Godin's Shepard Leisure Time Exercise Questionnaire |
| Skeletal muscle mass | 12 months | Change in skeletal muscle mass during the study evaluated with bioimpedance vectorial analysis and computed tomography scans |
Other
| Measure | Time frame | Description |
|---|---|---|
| Serum levels of immunologic markers | 12 months | Change in levels of soluble effectors and immuno-regulatory cells during the study by cytofluorimetry and validated biochemical assays |
Countries
Italy
Contacts
Primary ContactRiccardo Caccialanza, MD
Backup ContactAlessandra Ferrari, PharmD
Outcome results
None listed