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

NCT ID: NCT04534738

Last Updated: 2023-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-14
• Study Completion Date: 2022-02-20

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.

Conditions

Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Mediterranean Diet

Intervention Type: BEHAVIORAL

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

• 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Luke Peppone

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amber S. Kleckner, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

Pluta Cancer Center

Rochester, New York, United States

Wilmot Cancer Institute

Rochester, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

UCCS20082

Identifier Type: -

Identifier Source: org_study_id