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

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Enrolling

Conditions: Lung Cancer, Nonsmall Cell

Treatments: Dietary Supplement: Immunonutrition; Other: Control dietary intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05384873

0020364/22

Details and patient eligibility

About

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

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

Immunonutrition

Experimental group

Description:

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

Treatment:

Dietary Supplement: Immunonutrition

Control dietary intervention

Active Comparator group

Description:

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:

Other: Control dietary intervention