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Mediterranean Diet for Cancer (DANICA Trial)
Phase 1 & 2
Waitlist Available
Led By Amber S. Kleckner, PhD
Research Sponsored by University of Rochester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights
DANICA Trial Summary
This trial will assess whether an 8-week Mediterranean Diet intervention can help cancer patients with fatigue and whether it improves their metabolism and mitochondrial function.
Eligible Conditions
- Cancer
DANICA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Scores From the 14-item Mediterranean Diet Questionnaire
The Number of Patients Who Enrolled Completed the Study.
Secondary outcome measures
The Functional Assessment of Chronic Illness-Fatigue (FACIT-F) Questionnaire
The Functional Assessment of Chronic Illness-Fatigue (FACIT-F) Questionnaire, Fatigue Subscale
Side effects data
From 2022 Phase 1 & 2 trial • 33 Patients • NCT0453473810%
Deep vein thrombosis
10%
Dental infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Usual Care
Mediterranean Diet
DANICA Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Mediterranean DietExperimental Treatment1 Intervention
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 II: Usual careActive Control1 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mediterranean Diet
2013
Completed Phase 4
~2350
Find a Location
Who is running the clinical trial?
University of RochesterLead Sponsor
833 Previous Clinical Trials
518,111 Total Patients Enrolled
Amber S. Kleckner, PhDPrincipal InvestigatorUniversity of Rochester
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a tumor in your brain.You have specific dietary restrictions, such as allergies to nuts or gluten intolerance, that cannot be accommodated by a Mediterranean diet.You are planning to have radiation therapy to your head.You are already eating a diet similar to the Mediterranean diet, which includes foods like fruits, vegetables, whole grains, and healthy fats.
Research Study Groups:
This trial has the following groups:- Group 1: Mediterranean Diet
- Group 2: Usual care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there opportunities for volunteers to take part in this scientific experiment?
"Evidently, this study is not seeking further enrolment based on the information available through clinicaltrials.gov; it was first posted in November of 2020 and its last update occurred in March of 2022. Nevertheless, there are 677 other medical trials currently recruiting patients at present."
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