Immunonutrition for Improving the Efficacy of Immunotherapy in Patients With Metastatic Non-small Cell Lung Cancer

Lung Cancer, Nonsmall Cell Clinical Trial

— MURAL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05384873
• Other study ID #: 0020364/22
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: July 31, 2026

Study information

• Verified date: November 2023
• Source: IRCCS Policlinico S. Matteo
• Contact: Riccardo Caccialanza, MD
• Phone: 0382501615
• Email: r.caccialanza[@]smatteo.pv.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: July 31, 2026
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer, Nonsmall Cell
• Lung Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Policlinico San Matteo	Pavia

Sponsors (4)

Lead Sponsor	Collaborator
IRCCS Policlinico S. Matteo	Azienda Ospedaliera Universitaria Integrata Verona, Humanitas Hospital, Italy, San Luigi Gonzaga Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Secondary	Duration of response	Time to progression	24 months
Secondary	Overall survival	Overall survival	24 months
Secondary	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
Secondary	Skeletal muscle mass	Change in skeletal muscle mass during the study evaluated with bioimpedance vectorial analysis and computed tomography scans	12 months
Secondary	Fatigue	Change in fatigue during the study as assessed by the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) questionnaire	12 months
Secondary	Self-perceived quality of life	Change in quality of life during the study as assessed by validated questionnaires	12 months
Secondary	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