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Prolonged Nightly Fasting for Head and Neck Cancer
N/A
Waitlist Available
Led By Jameel Muzzaffar, MD
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
Newly diagnosed recurrent/metastatic head and neck squamous cell cancer not amenable to local therapy with curative intent and initiating standard of care immune checkpoint blocker for the first time
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 3 months
Awards & highlights
Study Summary
This trial will see if eating only during an 8-10 hour window each day, without cutting calories, can improve how well cancer patients respond to immunotherapy.
Who is the study for?
This trial is for adults with newly diagnosed, recurrent or metastatic head and neck cancer that can't be treated with surgery or radiation. They should be starting immunotherapy (like Nivolumab) for the first time, have a measurable tumor, and be in good physical condition. People underweight, with uncontrolled illnesses, diabetes, thyroid issues, pregnancy, eating disorders or certain brain metastases cannot join.Check my eligibility
What is being tested?
The study tests if eating only during an 8-10 hour window each day without reducing calories improves the effectiveness of immunotherapy in treating head and neck cancer compared to regular eating patterns.See study design
What are the potential side effects?
Potential side effects are not directly from the fasting intervention but may include hunger pangs or discomfort due to changes in usual eating habits. Immunotherapies like Nivolumab can cause immune-related reactions affecting various organs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
Select...
My head and neck cancer has returned or spread and cannot be cured with surgery or radiation, and I am starting immunotherapy for the first time.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in gut microbiome and microbial metabolites
Rates of Prolonged Nightly Fasting (PNF) compliance
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: A: Prolonged Nightly FastingExperimental Treatment1 Intervention
Participants will be educated on Prolonged Nightly Fasting (PNF) and the "mycircadianapp". Participants be allowed to choose any 10-hr period that falls between 6 AM- 6 PM, as feeding period. Participants will be recommended to follow study diet guidelines, eat to satiety and not count calories. Participants will be allowed to have water, beverages (<4 kcal) during the fasting period.
Group II: B: Regular Eating patternActive Control1 Intervention
Participants will follow a traditional eating pattern with no time restrictions.
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Who is running the clinical trial?
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
548 Previous Clinical Trials
135,599 Total Patients Enrolled
American Cancer Society, Inc.OTHER
224 Previous Clinical Trials
110,426 Total Patients Enrolled
Jameel Muzzaffar, MDPrincipal InvestigatorMoffitt Cancer Center
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active or can carry out light work.My head and neck cancer has returned or spread and cannot be cured with surgery or radiation, and I am starting immunotherapy for the first time.I do not have any severe illnesses or conditions that are not under control.I have brain metastases but they are treated and not causing symptoms.I do not have diabetes, thyroid issues, an eating disorder, or a metabolic disorder.
Research Study Groups:
This trial has the following groups:- Group 1: A: Prolonged Nightly Fasting
- Group 2: B: Regular Eating pattern
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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