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Completed

NCT Number: NCT04534738

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

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Pluta Cancer Center, Rochester, New York, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

  1. The Number of Patients Who Enrolled Completed the Study.

    Time frame: 8 weeks

    To assess feasibility of the study, we will report what percentage of patients who enrolled completed the study.

  2. Scores From the 14-item Mediterranean Diet Questionnaire

    Time frame: 8 weeks

    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.

Secondary outcomes

  1. The Functional Assessment of Chronic Illness-Fatigue (FACIT-F) Questionnaire

    Time frame: 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. Scores range from 0-160.

  2. The Functional Assessment of Chronic Illness-Fatigue (FACIT-F) Questionnaire, Fatigue Subscale

    Time frame: 8 weeks

    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.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Official study 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

Acronym: DANICA

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Sep 1, 2020
Registry last updated
Sep 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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