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NCT04293874 · ClinicalTrials.gov registry record · NA

Adaptive Symptom Care Using Fish-Based Nutritional Directives Post Breast Cancer

A NA study, sponsored by University of Connecticut.

Completed
Registry status
NA
Development phase
98
Enrollment target

NCT04293874 is a NA study that has completed, run by University of Connecticut. The registered enrollment target is 98 participants.

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The verdict

NCT04293874, a NA study, has completed, sponsored by University of Connecticut.

COMPLETED
Registry status
NA
Development phase
98 participants
Enrollment target

Study Summary

Inflammation has been consistently associated with psychoneurological symptoms (PNS) among breast cancer survivors (BCS). Evidence supporting interventional strategies promoting symptom-self management in reducing inflammation-induced PNS in BCS is limited. Current guidelines for BCS encourage the consumption of foods rich in omega-3 fatty acids. The omega-3 fatty acid docosahexaenoic acid (DHA), abundantly available in fish, has a role in inflammatory downregulation. Low dietary DHA has been associated with inflammation and fatigue in BCS. Dietary planning targeting increased fish consumption thereby reducing red and processed meats are components of the major nutritional recommendations for BCS. A critical gap exists in knowledge regarding interventions promoting adherence to dietary guidelines in BCS supporting PNS self-management. This investigation uses personalized meal planning among BCSs (n=150) who are 1-2 years post-treatment for early-stage breast cancer and experiencing PNS (pain, fatigue, depression, sleep disturbance, stress) to evaluate the feasibility of a personalized meal planning approach in supporting adherence to current dietary guidelines for BCS. As a first step in this program of research, we will evaluate the feasibility of an personalized meal planning approach in promoting adherence to dietary guidelines for BCS through evaluating the feasibility of a personalized meal planning approach in a cohort of BCSs with respect to recruitment, group allocation, salivary inflammatory quantification and receptivity to and adherence with dietary interventions. This investigation will also contribute to a preliminarily evaluation of the efficacy of high or low fish diet in reducing inflammation (IL-1β, IL-6, TNF-a) and PNS symptoms. Nationally, there is a priority for the development of personalized health strategies supporting self-management of adverse symptoms. This investigation focused on PNS in BCS is an initial step in generating new knowledge i

Interventions

  • BEHAVIORAL Personalized Meal Plan
  • BEHAVIORAL Dietary Omega-3LC intervention

Trial Details

FieldValue
Enrollment Target 98 participants
Start Date 2018-04-11
Est. Completion 2020-11-01
Phase NA

Sponsor

University of Connecticut

107 total trials

What the Registry Record Tells You About NCT04293874

The ClinicalTrials.gov registry entry for NCT04293874 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 98 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Connecticut, which has 107 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Personalized Meal Plan is the first listed.

NCT04293874 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04293874 about?

NCT04293874 is a clinical study titled "Adaptive Symptom Care Using Fish-Based Nutritional Directives Post Breast Cancer". Inflammation has been consistently associated with psychoneurological symptoms (PNS) among breast cancer survivors (BCS). Evidence supporting interventional strategies promoting symptom-self management in reducing inflammation-induced PNS in BCS is limited. Current guidelines for BCS encourage the c...

What is the current status of trial NCT04293874?

This trial is currently completed. It is a NA study. The enrollment target is 98 participants. The study started on 2018-04-11. Estimated completion is 2020-11-01.

What interventions are being tested in trial NCT04293874?

The interventions under investigation include: Personalized Meal Plan (BEHAVIORAL), Dietary Omega-3LC intervention (BEHAVIORAL).

Who is sponsoring clinical trial NCT04293874?

This trial is sponsored by University of Connecticut, which has 107 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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