RecruitingNCT05821751PRINCESSUpdated Apr 20, 2023

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

An interventional study of inulin and Pembrolizumab in Head and Neck Squamous Cell Carcinoma, sponsored by Fondazione del Piemonte per l'Oncologia. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-20.

Sponsored by Fondazione del Piemonte per l'Oncologia · Not applicable, Interventional, and Treatment

From the registry’s dates

Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as recruiting.
Registered 1 year 1 month after the study started (first participant enrolled Dec 2021, registered Jan 2023).
Started Dec 2021; still recruiting 4 years 10 months later.

Phase: Not applicable
Study type: Interventional
Enrollment: 40
Allocation: Non-randomized
Ages: 18 Years and older
Sex: All

Study 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 studied

Head and Neck Squamous Cell Carcinoma

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Keywords

microbiome
inulin
Immune Checkpoint Inhibitors
chemotherapy
cytokines
immune cells
HNSCC
Recurrent/Metastatic
Head and Neck Squamous Cell Carcinoma
Carcinoma
Head and Neck Carcinoma

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's planned enrollment of 40 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Fondazione del Piemonte per l'Oncologia is the lead sponsor of 39 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Written informed consent to study procedures;
Male or female, age > 18 years (at the time consent is obtained);
Histological or cytological documentation of HNSCC that was diagnosed as recurrent or metastatic and considered incurable by local therapies;
Indication to be treated with ICIs monotherapy, either pembrolizumab or nivolumab or in combination with chemotherapy, according to standard clinical practice;
ECOG Performance PS score \< 2;
Adequate kidney, liver and bone marrow function;
Will and ability to comply with the protocol.

Exclusion criteria

Exclusion Criteria:

Disease that is suitable for local therapy administered with curative intent;
Prior therapy with anti-PD-1 or anti-PD-L1 agents;
History of severe allergic reactions or hypersensitivity to trial drugs or any of their excipients;
Major surgery \< 28 days prior to receiving the first dose of study medication;
Toxicity from previous anticancer treatment that includes: Grade 3/4 toxicity considered related to prior therapy and that led to treatment discontinuation; toxicity related to prior treatment that has not resolved to > Grade 1;
Central nervous system (CNS) metastases and/or carcinomatous meningitis; with the following exception: patients with asymptomatic CNS metastases who are clinically stable and have no requirement for steroids for at least 14 days prior to the first dose of trial treatment. Patients with carcinomatous meningitis or leptomeningeal spread are excluded regardless of clinical stability.
Other additional malignancies that are progressing or require active treatment within the last 5 years with the exception of localized basal and squamous cell carcinoma of the skin or cervical cancer in situ.
Active autoimmune disease or syndrome that required systemic treatment within the past 2 years (with use of corticosteroids or immunosuppressive drugs). Replacement therapy (thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
Systemic steroid therapy (≥10 mg oral prednisone per day or equivalent) or other immunosuppressive agents within 7 days prior to the first dose of trial treatment.
Diagnosis of current pneumonitis or history of non-infectious pneumonitis that required steroids or other immunosuppressive agents;
Diagnosis of active infection that required systemic antibiotics therapy, orally or intravenous;.
Clinically significant cardiovascular disease within the 6 months prior to the first dose of trial treatment with a New York Heart Association (NYHA) grade II or greater congestive heart failure (CHF); symptomatic pericarditis.
Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness;
Any serious and/or unstable medical conditions, psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Receipt of any live vaccine within 30 days of planned start of study therapy.
Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 40 participants (estimated)

Study arms

Experimental
Arm A
Pembrolizumab in monotherapy or in combination with chemotherapy (platinum + 5 FU) in standard clinical practice according to the international and local guidelines + inulin
Dietary Supplement: inulin · Drug: Pembrolizumab
Experimental
Arm B
Nivolumab in monotherapy or in combination with chemotherapy (platinum + 5 FU) in standard clinical practice according to the international and local guidelines + inulin
Dietary Supplement: inulin · Drug: Nivolumab

Interventions

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

What researchers measure

Primary outcomes

Alpha diversity and Beta diversity analysis in the Gut Microbiota
Comparison of gut microbiota diversity with Shannon index in faeces samples. The analyses were conducted using QIIME software
Time frame: 12 month
Evaluation of circulating cytokines dynamics
Analysis of multiple cytokines for identify a cytokine signature related to a patient's outcome and be able to recognize patients who will benefit from treatment. Plasma Levels of 18 Cytokines TGF-, TNF-, VEGF, INF-, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, IL-12, IL-13, IL-15, CCL-2, CCL4, CCL-22, and CXCL-10 were evaluated with the Ella Simple Plex system (ProteinSimple™, San Jose, CA, USA)The concentrations were expressed in pg/mL. IL-21 was assessed with the ELISA method (R \& D System, Minneapolis, MN, USA). The measured optical densities were expressed as pg/mL.
Time frame: 12 month
Rate and evaluation of modification of circulating immune-phenotype dynamics
Rate and evaluation of modification of main circulating immune characters as T lymphocytes, B Lymphocytes, Tregs, neutrophils, Natural Killer, NKT, MDSC during study combination treatment
Time frame: 12 month
Evaluation of Immune-predictive molecules
Evaluation of immunomodulatory molecules (PD-1; PD-L1/2; HLA- E; TIM3; LAG3; OX40; VISTA; ICOS) will be assessed at each established time point
Time frame: 12 month
Overall Survival Rate
OS and the correlation with GM diversity and circulating cytokines and immune cells dynamics.
Time frame: through study completion, an average of 1 year

Study locations

1 of 1 sites recruiting

Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo
Candiolo, Turin 10060, Italy
- Annamaria Nuzzo, PhD · Contact · annamaria.nuzzo@ircc.it · +390119933398
- Danilo Galizia, MD · Principal investigator
Recruiting

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 20, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05821751
Lead sponsor: Fondazione del Piemonte per l'Oncologia
Collaborators: Ospedale Santa Croce-Carle Cuneo, Università degli Studi di Trento
Responsible party: Sponsor
First posted: Apr 20, 2023
Start date: Dec 2, 2021
Primary completion: Dec 2, 2024 (estimated)
Completion: Dec 2, 2025 (estimated)
Last update: Apr 20, 2023

Study contacts

Danilo Galizia

Contact

danilo.galizia@ircc.it

+39 011 993 3250

Marco Merlano

Contact

marcocarlo.merlano@ircc.it

+39 011 993 3250

Danilo Galizia

principal investigator · FPO IRCCS Candiolo

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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