The Effect of a Mediterranean Diet Intervention on Cancer-related Fatigue and Mitochondrial Function During Chemotherapy

Cancer Clinical Trial

— DANICA  

Official title:

Diet And Nutrition In CAncer (The DANICA Study): The Effect of a Mediterranean Diet Intervention on Cancer-related Fatigue and Mitochondrial Function During Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04534738
• Other study ID #: UCCS20082
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: November 14, 2020
• Est. completion date: February 20, 2022

Study information

• Verified date: September 2023
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: February 20, 2022
• Est. primary completion date: December 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Cancer
• Fatigue

Intervention

Behavioral:
• Mediterranean Diet
The Mediterranean Diet is high in fruit, vegetables, legumes, nuts and seeds, whole grains, and olive oil; moderate in seafood, dairy products (e.g., cheese and yogurt but not whole milk or butter), eggs, poultry, and red wine with meals; and low consumption of sweet desserts, red meat, and highly processed foods.

Locations

Country	Name	City	State
United States	Pluta Cancer Center	Rochester	New York
United States	Wilmot Cancer Institute	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Number of Patients Who Enrolled Completed the Study.	To assess feasibility of the study, we will report what percentage of patients who enrolled completed the study.	8 weeks
Primary	Scores From the 14-item Mediterranean Diet Questionnaire	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.	8 weeks
Secondary	The Functional Assessment of Chronic Illness-Fatigue (FACIT-F) Questionnaire	Fatigue will be measured using the Functional Assessment of Chronic Illness-Fatigue (FACIT-F). This is a 40-item questionnaire in which a higher score indicates greater well-being. Scores range from 0-160.	8 weeks
Secondary	The Functional Assessment of Chronic Illness-Fatigue (FACIT-F) Questionnaire, Fatigue Subscale	Fatigue will be measured using the Functional Assessment of Chronic Illness-Fatigue (FACIT-F), fatigue subscale. This is a 13-item subscale of the FACIT-F questionnaire in which a higher score indicates less fatigue. Scores range from 0-52.	8 weeks