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| ID | Type | Description | Link |
|---|---|---|---|
| 20121102 | Other Grant/Funding Number | American Cancer Society |
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| Name | Class |
|---|---|
| American Cancer Society, Inc. | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A: Prolonged Nightly Fasting | Experimental | 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. |
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| B: Regular Eating pattern | Active Comparator | Participants will follow a traditional eating pattern with no time restrictions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prolonged Nightly Fasting | Behavioral | Limiting daily period of food intake to 10 hours and nightly fasting period to 14 hours. |
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| Measure | Description | Time Frame |
|---|---|---|
| Rates of Prolonged Nightly Fasting (PNF) compliance | Adherence to the 8-10 hour time restricted feeding window will be measured using "mycircadianclock" app ,which has been validated as a tool to conveniently and reliably track time of food intake and its correlation with timing of the day and sleep. It can be tailored to restrict feeding duration to specific set points. | at 3 months |
| Change in gut microbiome and microbial metabolites | Changes in gut microbiome composition/diversity as well as gut microbial metabolites in participants using PNF will be compared with participants that are not restricting eating times will be measured using stool samples. | Baseline and at 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christine Chung, MD | Moffitt Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
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| Label | URL |
|---|---|
| Moffitt Cancer Center Clinical Trials website | View source |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D000093763 | Intermittent Fasting |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005215 | Fasting |
| D005247 | Feeding Behavior |
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| Regular Eating pattern | Behavioral | Food intake not limited to a specific time during day/night. |
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| D001519 |
| Behavior |