The Effect of Prebiotic Inulin on Patients Affected by R/M HNSCC Treated With Immune Checkpoint Inhibitors

NARecruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

December 2, 2021

Primary Completion Date

December 2, 2024

Study Completion Date

December 2, 2025

Conditions
Head and Neck Squamous Cell Carcinoma
Interventions
DIETARY_SUPPLEMENT

inulin

"Inulin will be given to enrolled patients according to manufacturer label indications.~ICIs (i.e. nivolumab and pembrolizumab) alone or in combination with chemotherapy, if clinically indicated, and their administration scheduling will be planned as per international and local guidelines."

DRUG

Pembrolizumab

Pembrolizumab in monotherapy or in combination with chemotherapy (platinum + 5 FU) in standard clinical practice according to the international and local guidelines + inulin

DRUG

Nivolumab

Nivolumab in monotherapy or in combination with chemotherapy (platinum + 5 FU) in standard clinical practice according to the international and local guidelines + inulin

Trial Locations (1)

10060

RECRUITING

Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo, Candiolo

All Listed Sponsors
collaborator

Ospedale Santa Croce-Carle Cuneo

OTHER

collaborator

Università degli Studi di Trento

OTHER

lead

Fondazione del Piemonte per l'Oncologia

OTHER