Immunonutrition for Improving the Efficacy of Immunotherapy in Patients With Metastatic Non-small Cell Lung Cancer
- Conditions
- Lung Cancer, Nonsmall Cell
- Interventions
- Dietary Supplement: ImmunonutritionOther: Control dietary intervention
- Registration Number
- NCT05384873
- Lead Sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 180
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Immunonutrition 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 Control dietary intervention 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Overall survival 24 months Overall survival
Duration of response 24 months Time to progression
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
Skeletal muscle mass 12 months Change in skeletal muscle mass during the study evaluated with bioimpedance vectorial analysis and computed tomography scans
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
Trial Locations
- Locations (1)
Fondazione IRCCS Policlinico San Matteo
🇮🇹Pavia, Italy