NCT05821751

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

The Effect of Prebiotic Inulin on Patients Affected by Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) Treated With Immune Checkpoint Inhibitors (ICIs): Princess Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Fondazione del Piemonte per l'Oncologia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The PRINCESS study is a hypothesis-generating, interventional, open-label, non pharmacological trial designed to characterize the translational and clinical implications of the regular assumptions of inulin on Gut Microbiota, circulating cytokines and immune cells dynamics during ICIs +/- chemotherapy on patients affected by R/M HNSCC.

Conditions

• Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-12-02
• Primary completion: 2024-12-02
• Completion: 2025-12-02
• First posted: 2023-04-20
• Last updated: 2023-04-20

Locations

1 site across 1 country: Italy