Phase 2
N=33
The Effect of a Mediterranean Diet Intervention on Cancer-related Fatigue and Mitochondrial Function During Chemotherapy
Cancer
Bottom Line
View on ClinicalTrials.gov: NCT04534738 ↗Enrolled (actual)
33
Serious AEs
24.2%
Results posted
Sep 2023
Primary outcome: Primary: The Number of Patients Who Enrolled Completed the Study. — 23; 10 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Mediterranean Diet (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Rochester
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Patients Who Enrolled Completed the Study. |
23; 10 | — |
| PRIMARY Scores From the 14-item Mediterranean Diet Questionnaire |
6.5; 5.2 | — |
| SECONDARY The Functional Assessment of Chronic Illness-Fatigue (FACIT-F) Questionnaire |
114.1; 116.9 | — |
| SECONDARY The Functional Assessment of Chronic Illness-Fatigue (FACIT-F) Questionnaire, Fatigue Subscale |
35.3; 36.0 | — |
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.
Eligibility Criteria
Inclusion Criteria (Participants must…):
- Have a diagnosis of cancer,
- Be scheduled to receive chemotherapy and have at least 6 weeks remaining,
- Be able to speak English,
- Be willing to adhere to study procedures, and
- Be able to provide written informed consent.
Exclusion Criteria (Participants must not…):
- Be on enteral or parenteral nutrition,
- Be pregnant,
- Have distant metastases,
- Have a brain tumor,
- Have any plan to get radiation to the head,
- Have specific dietary needs that a Mediterranean diet cannot meet (e.g., allergies to nuts, gluten intolerance), or already be following the Mediterranean diet (i.e., have a score ≥10 on a modified 14-item Mediterranean Diet questionnaire).
Data sourced from ClinicalTrials.gov (NCT04534738). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.