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

NCT04293874 | Completed

• 1 other identifier: E-HHC-2016-0245
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief 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 in efficacious approaches toward guiding decisions on dietary behavior change strategies that are personalized, cost-effective, and sustainable.

Conditions

Fatigue; Depression; Pain; Sleep Disturbance; Stress; Survivorship; Breast Cancer; Dietary Habits

Keywords

breast cancer survivor; dietary omega-3 intervention; psychoneurological symptoms

Outcome Measures

Primary Outcomes (5)

• Change from baseline depressive symptom at 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

  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

  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

  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

  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 Outcomes (1)

• Change from baseline salivary inflammatory markers at week 10

  3 years

Study Arms (2)

Low Omega-3LC group

EXPERIMENTAL

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; Behavioral: Dietary Omega-3LC intervention

High Omega-3LC group

EXPERIMENTAL

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; Behavioral: Dietary Omega-3LC intervention

Interventions

Personalized Meal Plan BEHAVIORAL

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.

High Omega-3LC group; Low Omega-3LC group

Dietary Omega-3LC intervention BEHAVIORAL

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.

High Omega-3LC group; Low Omega-3LC group

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• years of age
• Able/willing to sign informed consent.

You may not qualify if:

• Non English-speaking

Sponsors & Collaborators

• University of Connecticut: lead
• Hartford HealthCare: collaborator
• Seafood Industry Research Fund: collaborator
• Alaskan Seafood Marketing Institute: collaborator
• Academy of Nutrition and Dietetics: collaborator

Study Sites (1)

Hartford HealthCare Cancer Institue

Hartford, Connecticut, 06102, United States

Location

MeSH Terms

Conditions

Fatigue; Depression; Pain; Parasomnias; Breast Neoplasms; Feeding Behavior

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Neurologic Manifestations; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior, Animal

Study Officials

• Michelle P Judge, PhD

  University of Connecticut

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 27, 2020
• First Posted: March 3, 2020
• Study Start: April 11, 2018
• Primary Completion: November 1, 2020
• Study Completion: November 1, 2020
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)