Effect of prebiotic inulin on patients with advanced head and neck cancer receiving immune therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the impact of prebiotic inulin on gut microbiota and immune response in patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) who are being treated with immune checkpoint inhibitors, specifically pembrolizumab or nivolumab. It is an open-label, interventional trial that aims to explore how inulin may influence circulating cytokines and immune cell dynamics during treatment. The study will enroll patients who meet specific eligibility criteria, including those with a performance status of less than 2 and adequate organ function. The findings could provide insights into the role of gut microbiota in enhancing cancer treatment outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

Exclusion Criteria:

1. Disease that is suitable for local therapy administered with curative intent;
2. Prior therapy with anti-PD-1 or anti-PD-L1 agents;
3. History of severe allergic reactions or hypersensitivity to trial drugs or any of their excipients;
4. Major surgery \< 28 days prior to receiving the first dose of study medication;
5. 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;
6. 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.
7. 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.
8. 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.
9. 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.
10. Diagnosis of current pneumonitis or history of non-infectious pneumonitis that required steroids or other immunosuppressive agents;
11. Diagnosis of active infection that required systemic antibiotics therapy, orally or intravenous;.
12. 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.
13. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness;
14. Any serious and/or unstable medical conditions, psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
15. Receipt of any live vaccine within 30 days of planned start of study therapy.
16. 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.

Where it's running

• Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo
  Candiolo, Turin, Italy Recruiting

Study contacts

• Principal investigator: Danilo Galizia — FPO IRCCS Candiolo
• Study coordinator: Danilo Galizia
• Email: danilo.galizia@ircc.it
• Phone: +39 011 993 3250

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Neoadjuvant therapy with nimotuzumab, toripalimab, nab-paclitaxel, and cisplatin for locally advanced head and neck cancer

  This study tests a pre-surgery treatment combining targeted therapy, immunotherapy, and chemotherapy to see if it helps patients with locally advanced, resectable head and neck squamous cell carcinoma.

  Recruiting Phase 2 Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Hebei, Hebei · NCT07906587

• ICG with near-infrared imaging to visualize head and neck cancer during surgery

  This study tests whether first-window indocyanine green fluorescence seen during surgery matches the cancer extent seen on pathology in patients with head and neck squamous cell carcinoma.

  Recruiting Phase 2 Washington University School of Medicine · St Louis, Missouri · NCT07825597

• ABBV-253 in adults with advanced solid tumors

  This study tests ABBV-253 to see if it is safe, how it affects the cancer, and how the drug moves in the body for adults with advanced solid tumors.

  Recruiting at 3 sites Phase 1 AbbVie · Grand Rapids, Michigan and 2 other locations · NCT07807956

• Online Sharing for Head & Neck Cancer Support

  A mobile app designed for adults with head and neck cancer undergoing radiotherapy to see if daily social sharing and peer interaction can help reduce psychological distress.

  Recruiting West China Hospital · Chengdu, Sichuan · NCT07766226

• Telisotuzumab Adizutecan with Pembrolizumab as first-line treatment for recurrent or metastatic head and neck cancer

  This study tests a combination treatment to see if it helps people with newly diagnosed recurrent or metastatic head and neck squamous cell carcinoma who express the c-Met protein.

  Recruiting at 5 sites Phase 2 AbbVie · Duarte, California and 4 other locations · NCT07744126

• Mild heat therapy added to standard treatment for locally advanced head and neck cancer

  This early-stage trial tests whether mild hyperthermia can be safely added to standard radiotherapy with or without chemotherapy for locally advanced head and neck cancer.

  Recruiting Phase 1 Erasmus Medical Center · Rotterdam, South Holland · NCT07690618

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.