Clinical trial NCT04293874: Adaptive Symptom Care Using Fish-Based Nutritional Directives Post Breast Cancer
Official title: Association Between Dietary Omega-3 Fatty Acid Intake Patterns and Psychoneurological Symptoms in Women Following Treatment for Early-stage Breast Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Fatigue
Depression
Pain
Sleep Disturbance
Stress
Survivorship
Breast Cancer
Dietary Habits
Keywords: breast cancer survivor
dietary omega-3 intervention
psychoneurological symptoms
Lead sponsor: University of Connecticut
Sponsor class: OTHER
Collaborators: name: Hartford HealthCare
name: Seafood Industry Research Fund
name: Alaskan Seafood Marketing Institute
name: Academy of Nutrition and Dietetics
First posted: 2020-03-03
Enrollment: 98
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline depressive symptom at week 10
timeFrame: baseline, Week 3 and Week 10
measure: Change from baseline pain at week 10
timeFrame: baseline, Week 3 and Week 10
measure: Change from baseline fatigue at week 10
timeFrame: baseline, Week 3 and Week 10
measure: Change from baseline sleep disturbance at week 10
timeFrame: baseline, Week 3 and Week 10
measure: Change from baseline perceived stress at week 10
timeFrame: baseline, Week 3 and Week 10
Secondary outcomes:
measure: Change from baseline salivary inflammatory markers at week 10
timeFrame: 3 years
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Hartford HealthCare Cancer Institue
state: Connecticut
Study officials:
affiliation: University of Connecticut
name: Michelle P Judge, PhD
role: PRINCIPAL_INVESTIGATOR
References: