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NCT05083416
Effect of Prolonged Nightly Fasting on Immunotherapy Outcomes in HNSCC - Role of Gut Microbiome
Completed
NA
Last updated 9 February 2026
What this trial tests
NA trial testing Prolonged Nightly Fasting in Head and Neck Cancer in 29 participants. Completed in 8 February 2024.
Timeline
20 October 2021
Primary endpoint
31 March 2023
31 March 2023
8 February 2024
Quick facts
| Lead sponsor | H. Lee Moffitt Cancer Center and Research Institute |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 29 |
| Start date | 20 October 2021 |
| Primary completion | 31 March 2023 |
| Estimated completion | 8 February 2024 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Prolonged Nightly Fasting
- Regular Eating pattern
Conditions studied
- Head and Neck Cancer — all drugs for Head and Neck Cancer →
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Who can join
18 and older, any sex, with Head and Neck Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study aims to evaluate if eating within an 8-10-hour window during the day, without any caloric restriction, can lead to better response rates to immunotherapy in head and neck cancer patients.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Role of the gut microbiota in anticancer therapy: from molecular mechanisms to clinical applications.
Zhao LY, Mei JX, Yu G, Lei L, et al · · 2023 · cited 211× · PMID 37179402 · DOI 10.1038/s41392-023-01406-7 -
Effects of dietary intervention on human diseases: molecular mechanisms and therapeutic potential.
Xiao YL, Gong Y, Qi YJ, Shao ZM, et al · · 2024 · cited 120× · PMID 38462638 · DOI 10.1038/s41392-024-01771-x -
Gut microbiome in modulating immune checkpoint inhibitors.
Li X, Zhang S, Guo G, Han J, et al · · 2022 · cited 113× · PMID 35841869 · DOI 10.1016/j.ebiom.2022.104163 -
Role of gut microbiome in cancer immunotherapy: from predictive biomarker to therapeutic target.
Zhang M, Liu J, Xia Q. · · 2023 · cited 77× · PMID 37770953 · DOI 10.1186/s40164-023-00442-x -
Modulating gut microbiome in cancer immunotherapy: Harnessing microbes to enhance treatment efficacy.
Kang X, Lau HC, Yu J. · · 2024 · cited 65× · PMID 38631285 · DOI 10.1016/j.xcrm.2024.101478 -
Effect of fasting on cancer: A narrative review of scientific evidence.
Tiwari S, Sapkota N, Han Z. · · 2022 · cited 39× · PMID 35848874 · DOI 10.1111/cas.15492 -
Gut microbiota shapes cancer immunotherapy responses.
Lei W, Zhou K, Lei Y, Li Q, et al · · 2025 · cited 33× · PMID 40715107 · DOI 10.1038/s41522-025-00786-8 -
The Role of the Gut Microbiome in Cancer Immunotherapy: Current Knowledge and Future Directions.
Kiousi DE, Kouroutzidou AZ, Neanidis K, Karavanis E, et al · · 2023 · cited 29× · PMID 37046762 · DOI 10.3390/cancers15072101
Verify or expand the search:
- PubMed search for NCT05083416
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Prolonged Nightly Fasting
Trials testing the same drug.
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- NCT05581849 — Prolonged Nightly Fasting in Fibromyalgia · NA · terminated
- NCT04708860 — Feasibility of Fasting & Exercise in Pts With HR+ MBC · NA · completed
Other recruiting trials for Head and Neck Cancer
Currently open trials in the same condition.
- NCT07318220 — Prehabilitation Protocol for Head and Neck Cancer Patients · NA · recruiting
- NCT07524114 — Study of High-Precision Evaluation of Molecular ResiduaL Disease Through a PlatfOrm for Cancer TracKing and Interception · recruiting
- NCT07467083 — Development and Application of a Nurse-Led Preemptive Symptom Management Protocol for Head and Neck Cancer Patients Unde · Phase 3 · recruiting
- NCT07209189 — Neoadjuvant Chemotherapy and Programmed Cell Death Protein 1(PD-1) Inhibition for Head and Neck Cancer Treatment De-esca · Phase 2 · recruiting
- NCT06837480 — Photobiomodulation in Head and Neck Cancer-Related Chronic Lymphedema · NA · recruiting
Other H. Lee Moffitt Cancer Center and Research Institute trials
Trials by the same sponsor.
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- NCT06047977 — Tumor Infiltrating Lymphocyte Therapy for Pediatric High Risk Solid Tumors · Phase 1 · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT05083416 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by H. Lee Moffitt Cancer Center and Research Institute
- Last refreshed: 9 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05083416.
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