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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 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

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 • NCT04534738
10%
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

Mediterranean Diet (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04534738 — Phase 1 & 2
Cancer Research Study Groups: Mediterranean Diet, Usual care
Cancer Clinical Trial 2023: Mediterranean Diet Highlights & Side Effects. Trial Name: NCT04534738 — Phase 1 & 2
Mediterranean Diet (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04534738 — Phase 1 & 2

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."

Answered by AI
~8 spots leftby Mar 2025