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Fish-Based Nutrition for Breast Cancer Survivorship

N/A
Waitlist Available
Led By Michelle P Judge, PhD
Research Sponsored by University of Connecticut
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No diagnosis of dementia or active psychosis
Completed chemotherapy (except tamoxifen/aromatase inhibitors) and/or radiation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

Study Summary

This trial will look into whether personalized meal planning can help reduce inflammation-induced psychoneurological symptoms in breast cancer survivors by targeting increased fish consumption.

Who is the study for?
This trial is for breast cancer survivors aged 30-75, who finished treatment (except certain hormone therapies) 1-2 years ago and are experiencing symptoms like pain, fatigue, or sleep issues. They shouldn't have immune system conditions, a history of other cancers or dementia, and must be able to consent.Check my eligibility
What is being tested?
The study tests if personalized meal plans rich in omega-3 fatty acids from fish can help manage symptoms caused by inflammation in breast cancer survivors. It aims to see if these diets are feasible and effective at reducing inflammatory markers and improving well-being.See study design
What are the potential side effects?
Since the intervention involves dietary changes rather than medication, side effects may include digestive adjustments to new eating habits. However, no specific side effects are detailed as it's focused on nutrition.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I do not have dementia or active psychosis.
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I have finished chemotherapy or radiation, but may still be on hormone therapy.
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I don't have chronic immune conditions or take immunosuppressive drugs.
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I have never had chemotherapy or cancer before.
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My cancer has not come back.
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I am between 30 and 75 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline depressive symptom at week 10
Change from baseline fatigue at week 10
Change from baseline pain at week 10
+2 more
Secondary outcome measures
Change from baseline salivary inflammatory markers at week 10

Trial Design

2Treatment groups
Experimental Treatment
Group I: Low Omega-3LC groupExperimental Treatment2 Interventions
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.
Group II: High Omega-3LC groupExperimental Treatment2 Interventions
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.

Find a Location

Who is running the clinical trial?

University of ConnecticutLead Sponsor
186 Previous Clinical Trials
160,163 Total Patients Enrolled
Hartford HealthCareOTHER
8 Previous Clinical Trials
1,186 Total Patients Enrolled
Seafood Industry Research FundUNKNOWN
1 Previous Clinical Trials
107 Total Patients Enrolled
~3 spots leftby Aug 2024
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