Clinical TrialID 8260
The Effect of Prebiotic Inulin on Patients Affected by R/M HNSCC Treated With Immune Checkpoint Inhibitors
NCT05821751
Head and Neck Squamous Cell Carcinoma
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 8260
- Evidence Id
- 8260
- Core Evidence Id
- 8260
- Source Clinical Trial Id
- 8258
- Herb2 Clinical Trial Id
- HBCT008258
- Nct Id
- NCT05821751
- Title
- The Effect of Prebiotic Inulin on Patients Affected by R/M HNSCC Treated With Immune Checkpoint Inhibitors
- Status
- Recruiting
- Phase
- Study Result
- No
- Study Condition
- Head and Neck Squamous Cell Carcinoma
- Study Type
- Interventional
- Study Design
- Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
- Intervention
- DIETARY_SUPPLEMENT: inulin|DRUG: Pembrolizumab|DRUG: Nivolumab
- Intervention Allocation
- Non_Randomized
- Intervention Model
- Parallel
- Intervention Mask
- Intervention Purpose
- Treatment
- Gender
- All
- Age
- Adult, Older_Adult
- Enrollment
- 40
- Outcome Measure
- 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, 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., 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, 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, 12 month|Overall Survival Rate, OS and the correlation with GM diversity and circulating cytokines and immune cells dynamics., through study completion, an average of 1 year
- Sponsor Collaborator
- Fondazione del Piemonte per l'Oncologia|Ospedale Santa Croce-Carle Cuneo|Università degli Studi di Trento
- Funded By
- OTHER
- Location
- Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo, Candiolo, Turin, 10060, Italy
- Other Id
- CE IRCCS 301/2021
- Start Date
- 2021-12-02
- Primary Completion Date
- 2024-12-02
- Completion Date
- 2025-12-02
- First Posted
- 2023-04-20
- Results First Posted
- Last Update Posted
- 2023-04-20
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT05821751
- Title Cn
- Title En
- The Effect of Prebiotic Inulin on Patients Affected by R/M HNSCC Treated With Immune Checkpoint Inhibitors
- Bilingual Status
- semi_complete