Clinical Trial 21150

Cancer Type: Head & Neck
Study Type: Supportive Care
NCT#: NCT05083416

Phase: N/A
Principal Investigator: Muzaffar, Jameel

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Overview

Study Title

Effect of Prolonged Nightly Fasting (PNF) on Immunotherapy Treatment Outcomes in Patients with Advanced Head and Neck Cancer (HNSCC)-Role of Gut Microbiome

Summary

The purpose of this study is to determine if Prolonged nightly fast (PNF) /Time restricted eating leads to improved responses to ICB in patients with metastatic head and neck cancer.

Objective

Primary objective; Aim 1: Evaluate compliance to PNF in metastatic head and neck cancer patients, measured at 3 months. This is a pilot study in preparation of a larger RCT. The RCT will be considered feasible if our pilot study has >75 % retention rate of participants through the first 3 months. Aim 2: To evaluate dynamic changes in gut microbiome composition/diversity as well as gut microbial metabolites in patients on PNF and controls and corelate with response to ICB therapy. Response will be measured by objective response rate (ORR) of ICB using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 at 3 months

Treatments

Therapies

Medications

Inclusion Criteria

Inclusion Criteria:

Newly diagnosed recurrent /metastatic head and neck squamous cell cancer that is not amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy) and initiating standard of care immune checkpoint blocker- (Nivolumab, pembrolizumab, Atezolizumab, Avelumab or Durvalumab with or without chemotherapy), for the first time.

Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as outlined in RECIST version 1.1

Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.

18 years of age or older, able to understand and voluntarily consent.

Other criteria may apply

Exclusion Criteria

Exclusion Criteria:

BMI less than 18.5.

Diabetes mellitus, hyperthyroidism, pregnancy, any eating disorder including anorexia nervosa or bulimia, metabolic disorders that may affect gluconeogenesis or adaptation to short fasting periods.

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, autoimmune disease requiring systemic steroids, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Patients who have known leptomeningeal metastases or untreated or symptomatic brain metastases. Treated, asymptomatic brain metastasis can be included.