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

Last updated: September 21, 2023
Sponsor: University of Rochester
Overall Status: Completed

Phase

1/2

Condition

Pain (Pediatric)

Cancer

Treatment

Mediterranean Diet

Clinical Study ID

NCT04534738
UCCS20082
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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).

Study Design

Total Participants: 33
Treatment Group(s): 1
Primary Treatment: Mediterranean Diet
Phase: 1/2
Study Start date:
November 14, 2020
Estimated Completion Date:
February 20, 2022

Connect with a study center

  • Pluta Cancer Center

    Rochester, New York 14623
    United States

    Site Not Available

  • Wilmot Cancer Institute

    Rochester, New York 14642
    United States

    Site Not Available

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