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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: Completed Phase 1 study, sponsored by University of Rochester.
NCT04534738 is a Phase 1 study that has completed, run by University of Rochester. The registered enrollment target is 33 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To assess feasibility of the study, we will report what percentage of patients who enrolled completed the study.
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 |
What the finished NCT04534738 record still lists
NCT04534738 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower).
The record links to 0 conditions, and to 1 intervention - of which Mediterranean Diet is the first listed.
NCT04534738 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04534738's enrollment target sits among peer trials
33 1280th of 2000 higher than 705 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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