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

September 2, 2025 updated by: Michelle Judge, University of Connecticut

Association Between Dietary Omega-3 Fatty Acid Intake Patterns and Psychoneurological Symptoms in Women Following Treatment for Early-stage 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 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 in efficacious approaches toward guiding decisions on dietary behavior change strategies that are personalized, cost-effective, and sustainable.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
98

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Hartford HealthCare Cancer Institue

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

35 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • diagnosed with BCA between 1 and 2 years prior to study enrollment
  • completed chemotherapy (except tamoxifen/aromatase inhibitors) and/or radiation
  • no evidence of cancer recurrence;
  • no chronic medical conditions involving the immune system or regular use of immunosuppressive medications;
  • no history of previous chemotherapy or cancer
  • no diagnosis of dementia or active psychosis;
  • 30-75 years of age
  • Able/willing to sign informed consent.

Exclusion Criteria:

  • Women not meeting the inclusion criteria above;
  • Non English-speaking

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Low Omega-3LC group
Participants will consume a personalized meal plan for 2 weeks and consume an increased quantity of fish to 6 oz. wild salmon (1 steak, 6oz /steak)or 14.3 oz. (5.5 packs, 2.6 oz/pack) of chunk light tuna (1020 mg Omega-3LC/week) for 6 weeks.
Behavioral: Personalized Meal Plan
Personalized dietary plans will be developed incorporating the NPAGCS, while personalizing the plan based upon anthropometric characteristics, gender, age and self-reported activity level upon entry into the investigation, goals, typical dietary consumption patterns, and food preferences. A trained research assistant will use the USDA MyPlate88 site (www.choosemyplate.gov) to enter participant characteristics and determine the appropriate calorie level. A daily checklist will be then generated outlining the number of daily servings that should be consumed for each food group. Information will also be provided regarding serving sizes for different foods in the respective food groups and education will be provided regarding tailoring personal dietary preferences to meet the guidelines. Participants will be provided with a printed copy of their meal plan and instructed to initiate it for a 8-week period.
Behavioral: Dietary Omega-3LC intervention
Following randomization, participants will be provided with fish to be consumed for 6 weeks. As a component of the dietary intervention, participants in high and low omega-3LC group will be provided with frozen, wild caught salmon (or if they dislike salmon, prepackaged, individual use foil packs of chunk light tuna). Salmon and chunk light tuna were chosen due to high omega-3LC content, low methylmercury content, low cost and ease of use. Vacuum packed, frozen salmon will be delivered to participants in large freezer bags and instructed to arrange visit times to ensure they can go directly home following the visit. Instructions for safe storage, fish handling and recipes to avoid fatigue of fish will be also be provided to participants when they receive the fish.
Experimental: High Omega-3LC group
Participants will consume a personalized meal plan for 2 weeks and consume an increased quantity of fish to 12 oz. wild salmon (2 steak,12 oz /steak)or 28.6 oz. (11 packs, 2.6 oz/pack) of chunk light tuna (2040 mg Omega-3LC/week) for 6 weeks.
Behavioral: Personalized Meal Plan
Personalized dietary plans will be developed incorporating the NPAGCS, while personalizing the plan based upon anthropometric characteristics, gender, age and self-reported activity level upon entry into the investigation, goals, typical dietary consumption patterns, and food preferences. A trained research assistant will use the USDA MyPlate88 site (www.choosemyplate.gov) to enter participant characteristics and determine the appropriate calorie level. A daily checklist will be then generated outlining the number of daily servings that should be consumed for each food group. Information will also be provided regarding serving sizes for different foods in the respective food groups and education will be provided regarding tailoring personal dietary preferences to meet the guidelines. Participants will be provided with a printed copy of their meal plan and instructed to initiate it for a 8-week period.
Behavioral: Dietary Omega-3LC intervention
Following randomization, participants will be provided with fish to be consumed for 6 weeks. As a component of the dietary intervention, participants in high and low omega-3LC group will be provided with frozen, wild caught salmon (or if they dislike salmon, prepackaged, individual use foil packs of chunk light tuna). Salmon and chunk light tuna were chosen due to high omega-3LC content, low methylmercury content, low cost and ease of use. Vacuum packed, frozen salmon will be delivered to participants in large freezer bags and instructed to arrange visit times to ensure they can go directly home following the visit. Instructions for safe storage, fish handling and recipes to avoid fatigue of fish will be also be provided to participants when they receive the fish.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline depressive symptom at week 10
Time Frame: baseline, Week 3 and Week 10
Epidemiological Studies Depression Scale is 20-item self-report instrument. Each item is scored 0-4 at a 4-point scale, yielding a total between 0 and 80. A higher score indicates a worse depressive symptom.
baseline, Week 3 and Week 10
Change from baseline pain at week 10
Time Frame: baseline, Week 3 and Week 10
Brief Pain Inventory short form assesses the severity of pain, location of pain, pain medications, amount of pain relief in the past 24 hours or the past week, and the impact of pain on daily functions. Each item is scored 0-10 at a 10-point scale, with 0 representing no pain or no pain interference and 10 representing worst pain or complete pain interference. The mean of 4 severity items will be used as a measure of pain severity, and the mean of the 7 interference items will be used as a measure of pain interference.
baseline, Week 3 and Week 10
Change from baseline fatigue at week 10
Time Frame: baseline, Week 3 and Week 10
Brief Fatigue Inventory short form is a 9-item scale to assess cancer-related fatigue and its impact on daily functioning. Each item score 0-10 at a 10-point scale. On the BFI, severe fatigue can be defined as a mean score of 7 or higher.
baseline, Week 3 and Week 10
Change from baseline sleep disturbance at week 10
Time Frame: baseline, Week 3 and Week 10
The 21-item General Sleep Disturbance Scale consists of items evaluating various aspects of sleep disturbance (quality and quantity of sleep, sleep onset latency, number of awakenings, excessive daytime sleepiness, and medication use) over the past week. Items are rated on a scale ranging from 0 (never) to 7 (every day). All items are summed to produce a total score ranging from 0 (no sleep disturbance) to 147 (extreme sleep disturbance).
baseline, Week 3 and Week 10
Change from baseline perceived stress at week 10
Time Frame: baseline, Week 3 and Week 10
Levels of stress will be measured by the 10-item Perceived Stress Scale. Each item is rated on a 5-point scale ranging from 0 (never) to 4 (very often). The final score is obtained by reversing responses to the four positively stated items and then summing across all scale items. A higher score represents a higher perceived stress.
baseline, Week 3 and Week 10

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline salivary inflammatory markers at week 10
Time Frame: 3 years
To quantify salivary inflammatory markers (CRP, IL-1β, IL-6, TNFα), salivary samples will be collected at baseline, week 3, and 10 during the study period. Salivary assay kits (multiplex) specific to the inflammatory markers of interest will be used to quantify salivary samples according to established protocols.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Connecticut

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Academy of Nutrition and Dietetics
Hartford HealthCare
Seafood Industry Research Fund
Alaskan Seafood Marketing Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michelle P Judge, PhD, University of Connecticut

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 11, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 27, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 3, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 9, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • E-HHC-2016-0245

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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