The Effect of Prebiotic Inulin on Patients Affected by R/M HNSCC Treated With Immune Checkpoint I… (NCT05821751) | Clinical Trial Compass
UnknownNot Applicable
The Effect of Prebiotic Inulin on Patients Affected by R/M HNSCC Treated With Immune Checkpoint Inhibitors
Italy40 participantsStarted 2021-12-02
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
✕. 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;
What they're measuring
1
Alpha diversity and Beta diversity analysis in the Gut Microbiota
Timeframe: 12 month
2
Evaluation of circulating cytokines dynamics
Timeframe: 12 month
3
Rate and evaluation of modification of circulating immune-phenotype dynamics
Timeframe: 12 month
4
Evaluation of Immune-predictive molecules
Timeframe: 12 month
5
Overall Survival Rate
Timeframe: through study completion, an average of 1 year
✕. 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.