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

University of Connecticut

Status: Active, not recruiting

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

Treatments: Behavioral: Personalized Meal Plan; Behavioral: Dietary Omega-3LC intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04293874

E-HHC-2016-0245

Details and patient eligibility

About

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.

Enrollment: 98 patients

Sex: Female

Ages: 35 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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98 participants in 2 patient groups

Low Omega-3LC group

Experimental group

Description:

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.

Treatment:

Behavioral: Personalized Meal Plan

Behavioral: Dietary Omega-3LC intervention

High Omega-3LC group

Experimental group

Description:

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.

Treatment:

Behavioral: Personalized Meal Plan

Behavioral: Dietary Omega-3LC intervention