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

Sponsor

University of Rochester (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04534738

Collaborator

(none)

Enrollment

Locations

Arms

45.5

Anticipated Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer	Behavioral: Mediterranean Diet	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

42 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

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

Actual Study Start Date :

Nov 14, 2020

Anticipated Primary Completion Date :

Aug 30, 2023

Anticipated Study Completion Date :

Aug 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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.
No Intervention: 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.

Arm

Intervention/Treatment

Experimental: 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.

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.

No Intervention: 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.

Outcome Measures

Primary Outcome Measures

The percentage of patients who enrolled completed the study. [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 [8 weeks]
In order to assess adherence to the diet, we will report scores from the 14-item Mediterranean Diet questionnaire. A higher score indicates greater adherence to the Mediterranean Diet.

Secondary Outcome Measures

The Functional Assessment of Chronic Illness-Fatigue (FACIT-F) questionnaire [baseline, 4 weeks, and 8 weeks]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pluta Cancer Center	Rochester	New York	United States	14623
2	Wilmot Cancer Institute	Rochester	New York	United States	14642

Sponsors and Collaborators

University of Rochester

Investigators

Principal Investigator: Amber S. Kleckner, PhD, University of Rochester

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Luke Peppone, Associate Professor, University of Rochester

ClinicalTrials.gov Identifier:

NCT04534738

Other Study ID Numbers:

UCCS20082

First Posted:

Sep 1, 2020

Last Update Posted:

Apr 8, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Luke Peppone, Associate Professor, University of Rochester

nutrition

diet

Additional relevant MeSH terms:

Fatigue

Study Results

No Results Posted as of Apr 8, 2022