Immunernæring for å forbedre effekten av immunterapi hos pasienter med metastatisk ikke-småcellet lungekreft (MURAL)
Multisenter, randomisert, åpent, parallellgruppeforsøk for å evaluere immunernæring for å forbedre effektiviteten av immunterapi hos pasienter med metastatisk ikke-småcellet lungekreft, som gjennomgår systematisk ernæringsrådgivning
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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Riccardo Caccialanza, MD
- Telefonnummer: 0039 0382501615
- E-post: r.caccialanza@smatteo.pv.it
Studer Kontakt Backup
- Navn: Alessandra Ferrari, PharmD
- Telefonnummer: 0039 0382503689
- E-post: alessandra.ferrari@smatteo.pv.it
Studiesteder
-
-
-
Pavia, Italia
- Rekruttering
- Fondazione IRCCS Policlinico San Matteo
-
Ta kontakt med:
- Riccardo Caccialanza, MD
- Telefonnummer: +390382501615
- E-post: r.caccialanza@smatteo.pv.it
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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 |
|
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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Progression-Free Survival (PFS)
Tidsramme: 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. |
12 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall survival
Tidsramme: 24 months
|
Overall survival |
24 months
|
|
Duration of response
Tidsramme: 24 months
|
Time to progression |
24 months
|
|
Treatment-related moderate-severe adverse events as assessed by Common Terminology Criteria for Adverse Events [CTCAE v5.0]
Tidsramme: 4 months
|
Difference in the incidence of grade >=3 toxicity, according to CTCAE v5.0 |
4 months
|
|
Skeletal muscle mass
Tidsramme: 12 months
|
Change in skeletal muscle mass during the study evaluated with bioimpedance vectorial analysis and computed tomography scans |
12 months
|
|
Fatigue
Tidsramme: 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
Tidsramme: 12 months
|
Change in quality of life during the study as assessed by validated questionnaires |
12 months
|
|
Self-reported physical activity level
Tidsramme: 12 months
|
Change in self-reported physical activity level as assessed by the Godin's Shepard Leisure Time Exercise Questionnaire |
12 months
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Serum levels of immunologic markers
Tidsramme: 12 months
|
Change in levels of soluble effectors and immuno-regulatory cells during the study by cytofluorimetry and validated biochemical assays |
12 months
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Riccardo Caccialanza, MD, Fondazione IRCCS Policlinico San Matteo
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Neoplasmer etter nettsted
- Neoplasmer
- Sykdommer i luftveiene
- Lungesykdommer
- Neoplasmer i luftveiene
- Thoracale neoplasmer
- Lungeneoplasmer
- Karsinom, bronkogent
- Bronkiale neoplasmer
- Karsinom, ikke-småcellet lunge
- Kosthold, mat og ernæring
- Fysiologiske fenomener
- Ernæringsfysiologiske fenomener
- Kosthold
- Immunonæringsdiett
Andre studie-ID-numre
- 0020364/22
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Depending on a specific research question and according to a study protocol to be approved by the Ethics Committee
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .