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Prolonged Nightly Fasting for Head and Neck Cancer

Q: How many participants have been recruited into this trial thus far?

<p>Affirmative, clinicaltrials.gov data verifies that this trial is currently recruiting volunteers. This investigation was initially posted on October 20th 2021 and the most recent revision occurred on August 11th 2022. The research necessitates 52 individuals from 1 centre.</p>

Q: Do any opportunities remain for participants to join this experiment?

<p>Affirmative. The information hosted on clinicaltrials.gov confirms that this research project, which was initially advertised in October 2021, is presently looking for participants to enrol. Currently 52 volunteers are needed from 1 medical centre.</p>

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 below

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I am fully active or can carry out light work.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 3 months for reporting.

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.

0 / 2Eligibility criteria met

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Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor

542 Previous Clinical Trials

135,463 Total Patients Enrolled

American Cancer Society, Inc.OTHER

224 Previous Clinical Trials

110,426 Total Patients Enrolled

Jameel Muzzaffar, MDPrincipal InvestigatorMoffitt Cancer Center

Media Library

Prolonged Nightly Fasting Clinical Trial Eligibility Overview. Trial Name: NCT05083416 — N/A

Head and Neck Cancers Research Study Groups: A: Prolonged Nightly Fasting, B: Regular Eating pattern

Head and Neck Cancers Clinical Trial 2023: Prolonged Nightly Fasting Highlights & Side Effects. Trial Name: NCT05083416 — N/A

Prolonged Nightly Fasting 2023 Treatment Timeline for Medical Study. Trial Name: NCT05083416 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have been recruited into this trial thus far?

"Affirmative, clinicaltrials.gov data verifies that this trial is currently recruiting volunteers. This investigation was initially posted on October 20th 2021 and the most recent revision occurred on August 11th 2022. The research necessitates 52 individuals from 1 centre."

Answered by AI

Do any opportunities remain for participants to join this experiment?

"Affirmative. The information hosted on clinicaltrials.gov confirms that this research project, which was initially advertised in October 2021, is presently looking for participants to enrol. Currently 52 volunteers are needed from 1 medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effect of Prolonged Nightly Fasting on Immunotherapy Outcomes in HNSCC - Role of Gut Microbiome

2021. "Effect of Prolonged Nightly Fasting on Immunotherapy Outcomes in HNSCC - Role of Gut Microbiome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05083416.

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