Immunnutrition för att förbättra effektiviteten av immunterapi hos patienter med metastaserad icke-småcellig lungcancer (MURAL)
Multicenter, randomiserad, öppen, parallellgruppsförsök för att utvärdera immunnutrition för att förbättra effektiviteten av immunterapi hos patienter med metastaserad icke-småcellig lungcancer, som genomgår systematisk näringsrådgivning
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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Riccardo Caccialanza, MD
- Telefonnummer: 0039 0382501615
- E-post: r.caccialanza@smatteo.pv.it
Studera Kontakt Backup
- Namn: Alessandra Ferrari, PharmD
- Telefonnummer: 0039 0382503689
- E-post: alessandra.ferrari@smatteo.pv.it
Studieorter
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Pavia, Italien
- Rekrytering
- Fondazione IRCCS Policlinico San Matteo
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Kontakt:
- Riccardo Caccialanza, MD
- Telefonnummer: +390382501615
- E-post: r.caccialanza@smatteo.pv.it
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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 |
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 |
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Aktiv komparator: 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. |
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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Progression-Free Survival (PFS)
Tidsram: 12 months
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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
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Overall survival
Tidsram: 24 months
|
Overall survival |
24 months
|
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Duration of response
Tidsram: 24 months
|
Time to progression |
24 months
|
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Treatment-related moderate-severe adverse events as assessed by Common Terminology Criteria for Adverse Events [CTCAE v5.0]
Tidsram: 4 months
|
Difference in the incidence of grade >=3 toxicity, according to CTCAE v5.0 |
4 months
|
|
Skeletal muscle mass
Tidsram: 12 months
|
Change in skeletal muscle mass during the study evaluated with bioimpedance vectorial analysis and computed tomography scans |
12 months
|
|
Fatigue
Tidsram: 12 months
|
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
Tidsram: 12 months
|
Change in quality of life during the study as assessed by validated questionnaires |
12 months
|
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Self-reported physical activity level
Tidsram: 12 months
|
Change in self-reported physical activity level as assessed by the Godin's Shepard Leisure Time Exercise Questionnaire |
12 months
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Serum levels of immunologic markers
Tidsram: 12 months
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Change in levels of soluble effectors and immuno-regulatory cells during the study by cytofluorimetry and validated biochemical assays |
12 months
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Huvudutredare: Riccardo Caccialanza, MD, Fondazione IRCCS Policlinico San Matteo
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 0020364/22
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Depending on a specific research question and according to a study protocol to be approved by the Ethics Committee
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