Breast Cancer Clinical Trial

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

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.

View Eligibility Criteria

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

Study is for people with:

Breast Cancer

Estimated Enrollment:

150

Study ID:

NCT04293874

Recruitment Status:

Suspended

Sponsor:

University of Connecticut

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There is 1 Location for this study

See Locations Near You

Hartford HealthCare Cancer Institue
Hartford Connecticut, 06102, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

150

Study ID:

NCT04293874

Recruitment Status:

Suspended

Sponsor:


University of Connecticut

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.