Diet And Nutrition In CAncer (The DANICA Study): The Effect of a Mediterranean Diet Intervention on Cancer-related Fatigue and Mitochondrial Function During Chemotherapy
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- University of Rochester
- Enrollment
- 33
- Locations
- 2
- Primary Endpoint
- The Number of Patients Who Enrolled Completed the Study.
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Arms & Interventions
Mediterranean Diet
Participants in the Mediterranean Diet arm are asked to follow a Mediterranean Diet for 8 weeks. The diet is ad libitum. A combination of fresh, frozen, and shelf-stable meals are provided for the first 4 weeks. Also during the first 4 weeks, participants receive an education session to discuss how to effectively implement a Mediterranean Diet into their daily routine.
Intervention: Mediterranean Diet (Behavioral)
Usual care
Participants in the usual care are will complete all the same study assessments as those in the intervention group. They will not receive any specific dietary advice, but they will be permitted to seek dietary advice outside the study. Data from this group are indispensable in understanding the nutritional habits and preferences of patients undergoing chemotherapy, and these data will be used to optimize nutritional interventions in future studies. At the end of the 8-week intervention, the participants in the usual care group will be provided the intervention materials gratis, including one-week of Mediterranean Diet food and education materials.
Outcomes
Primary Outcomes
The Number of Patients Who Enrolled Completed the Study.
Time Frame: 8 weeks
To assess feasibility of the study, we will report what percentage of patients who enrolled completed the study.
Scores From the 14-item Mediterranean Diet Questionnaire
Time Frame: 8 weeks
In order to assess adherence to the diet, we will report scores from the 14-item Mediterranean Diet questionnaire at 8 weeks. Scores range from 0 to 14 points. A higher score indicates greater adherence to the Mediterranean Diet.
Secondary Outcomes
- The Functional Assessment of Chronic Illness-Fatigue (FACIT-F) Questionnaire(8 weeks)
- The Functional Assessment of Chronic Illness-Fatigue (FACIT-F) Questionnaire, Fatigue Subscale(8 weeks)
Investigators
Luke Peppone
Associate Professor
University of Rochester