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

NCT04534738 | Completed Phase 1 Results

• 1 other identifier: UCCS20082
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 2

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

Keywords

nutrition; diet

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• 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

Study Arms (2)

Mediterranean Diet

EXPERIMENTAL

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

Usual care

NO INTERVENTION

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.

Interventions

Mediterranean Diet 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.

Mediterranean Diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (2)

Pluta Cancer Center

Rochester, New York, 14623, United States

Location

Wilmot Cancer Institute

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Diet, Mediterranean

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Results Point of Contact

• Title: Amber Kleckner, PhD
• Organization: University of Maryland Baltimore

amber.kleckner@umaryland.edu

410-706-5961

Study Officials

• Amber S. Kleckner, PhD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 17, 2020
• First Posted: September 1, 2020
• Study Start: November 14, 2020
• Primary Completion: December 9, 2021
• Study Completion: February 20, 2022
• Last Updated: September 22, 2023
• Results First Posted: September 22, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)