Improving health in breast cancer survivors, a novel dietary approach

Not Applicable

Completed

• Conditions: Breast Cancer; Diet and Nutrition - Other diet and nutrition disorders; Cancer - Breast

• Registration Number: ACTRN12616000003471
• Lead Sponsor: The University of Auckland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-01-06
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 45

Inclusion Criteria

Those aged 50 or above, diagnosed with grade 1-3 breast cancer and three or more months following active treatment and a body mass index (BMI) >25 will be enrolled. Participants can be on hormonal therapy. Participants will need to provide medical information regarding their breast cancer grade. We request participants provide receptor expression and use of hormone therapy, but those who wish to keep this information private will still be eligible.

Exclusion Criteria

We will exclude those on anti-inflammatory medication; those who drink more than 2 standard alcoholic beverages per day; those diagnosed with diabetes mellitus or those who smoke tobacco.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Weight. Measured on calibrated, ISAK accredited body weight scales in the clinical centre by an ISAK accredited anthropometrist.[Completion of intervention (6 months), and 6 months post intervention (12 months)];Blood lipids (LDL-chol, Total cholesterol). [Completion of intervention (6 months), and 6 months post intervention (12 months)];HbA1c (whole blood), assessed using ion exchange chromotography[Completion of intervention (6 months), and 6 months post intervention (12 months)]

Secondary Outcome Measures

Name	Time	Method
DNA damage (The comet assay)[Completion of intervention (6 months), and 6 months post intervention (12 months)];Quality of life questionnaire (FACT-B)[Completion of intervention (6 months), and 6 months post intervention (12 months)];Dietary intake questionnaire (PREDIMED) [Completion of intervention (6 months), and 6 months post intervention (12 months)];C-RP (serum sample)[Completion of intervention (6 months) and 6 months post intervention (12 months)];Fatty acid profile (FAMES assay)[At completion of trial (6 months) and 6 months post intervention (12 months)]