Cancer
Conditions
Keywords
nutrition, diet
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.
Interventions
BEHAVIORALMediterranean 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.
Sponsors
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Number 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 at 8 weeks. Scores range from 0 to 14 points. A higher score indicates greater adherence to the Mediterranean Diet. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Functional Assessment of Chronic Illness-Fatigue (FACIT-F) Questionnaire | 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. |
| The Functional Assessment of Chronic Illness-Fatigue (FACIT-F) Questionnaire, Fatigue Subscale | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 23 |
| 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. | 10 |
| Total | 33 |
Baseline characteristics
| Characteristic | Mediterranean Diet | Total | Usual Care |
|---|---|---|---|
| Age, Continuous | 51.7 years STANDARD_DEVIATION 14.2 | 51.0 years STANDARD_DEVIATION 14.6 | 49.2 years STANDARD_DEVIATION 16.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 23 Participants | 33 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 20 Participants | 29 Participants | 9 Participants |
| Region of Enrollment United States | 23 participants | 33 participants | 10 participants |
| Sex: Female, Male Female | 21 Participants | 31 Participants | 10 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 0 Participants |
| Type of cancer Breast cancer | 20 Participants | 30 Participants | 10 Participants |
| Type of cancer Other | 3 Participants | 3 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 10 |
| other Total, other adverse events | 0 / 23 | 0 / 10 |
| serious Total, serious adverse events | 6 / 23 | 2 / 10 |
Outcome results
Primary
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.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mediterranean Diet | Scores From the 14-item Mediterranean Diet Questionnaire | 6.5 units on a scale | Standard Deviation 2.6 |
| Usual Care | Scores From the 14-item Mediterranean Diet Questionnaire | 5.2 units on a scale | Standard Deviation 3 |
Primary
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.
Time frame: 8 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mediterranean Diet | The Number of Patients Who Enrolled Completed the Study. | 23 Participants |
| Usual Care | The Number of Patients Who Enrolled Completed the Study. | 10 Participants |
Secondary
The Functional Assessment of Chronic Illness-Fatigue (FACIT-F) Questionnaire
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.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mediterranean Diet | The Functional Assessment of Chronic Illness-Fatigue (FACIT-F) Questionnaire | 114.1 units on a scale | Standard Deviation 28.4 |
| Usual Care | The Functional Assessment of Chronic Illness-Fatigue (FACIT-F) Questionnaire | 116.9 units on a scale | Standard Deviation 20.4 |
Secondary
The Functional Assessment of Chronic Illness-Fatigue (FACIT-F) Questionnaire, Fatigue Subscale
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.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mediterranean Diet | The Functional Assessment of Chronic Illness-Fatigue (FACIT-F) Questionnaire, Fatigue Subscale | 35.3 units on a scale | Standard Deviation 12.1 |
| Usual Care | The Functional Assessment of Chronic Illness-Fatigue (FACIT-F) Questionnaire, Fatigue Subscale | 36.0 units on a scale | Standard Deviation 9.8 |