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NCT04534738 · ClinicalTrials.gov registry record · Phase 1
The Effect of a Mediterranean Diet Intervention on Cancer-related Fatigue and Mitochondrial Function During Chemotherapy
A Phase 1 study, sponsored by University of Rochester.
- Completed
- Registry status
- Phase 1
- Development phase
- 33
- Enrollment target
NCT04534738 is a Phase 1 study that has completed, run by University of Rochester. The registered enrollment target is 33 participants.
The verdict
NCT04534738, a Phase 1 study, has completed, sponsored by University of Rochester.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 33 participants
- Enrollment target
Study Summary
This study will assess the feasibility of delivering an 8-week Mediterranean Diet intervention as well as the intervention's preliminary efficacy on cancer-related fatigue among patients undergoing chemotherapy, compared to usual care. In the first 4 weeks of the intervention, we will provide the participants with food and educate them on the principles and components of the Mediterranean Diet, while in the second 4 weeks participants will prepare their own food. In addition, we will evaluate changes in metabolism and mitochondrial function during 4 weeks of chemotherapy and determine how adherence to a Mediterranean diet modulates these changes during these 4 weeks. The hypothesis is that the intervention will promote adherence to the Mediterranean Diet. The second hypothesis is that adherence will be associated with alleviation of fatigue and improvements in metabolic and mitochondrial function.
Interventions
- BEHAVIORAL Mediterranean Diet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2020-11-14 |
| Est. Completion | 2022-02-20 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04534738
The ClinicalTrials.gov registry entry for NCT04534738 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Rochester, which has 636 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Mediterranean Diet is the first listed.
NCT04534738 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04534738 about?
NCT04534738 is a clinical study titled "The Effect of a Mediterranean Diet Intervention on Cancer-related Fatigue and Mitochondrial Function During Chemotherapy". This study will assess the feasibility of delivering an 8-week Mediterranean Diet intervention as well as the intervention's preliminary efficacy on cancer-related fatigue among patients undergoing chemotherapy, compared to usual care. In the first 4 weeks of the intervention, we will provide the pa...
What is the current status of trial NCT04534738?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2020-11-14. Estimated completion is 2022-02-20.
What interventions are being tested in trial NCT04534738?
The interventions under investigation include: Mediterranean Diet (BEHAVIORAL).
Who is sponsoring clinical trial NCT04534738?
This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.
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