None listed
Conditions
Brief summary
Background: Breast cancer is the most common cancer amongst women in western countries, including New Zealand. Following the introduction of the national breast screening programme and increased breast cancer awareness, mortality rates in New Zealand have dropped. Despite this, more than 600 women die each year from the disease. Age, gender and genotype have been identified as risk factors for breast cancer, but are beyond individual control. Fortunately, modifiable factors such as diet, weight, alcohol consumption, tobacco use and physical activity have been shown to reduce breast cancer risk. Many of these modifiable factors influence inflammation, and chronic inflammation is associated with an increased risk of cancer development, progression and recurrence. Recent studies demonstrate that cancers are associated with an inflammatory microenvironment that promotes tumour growth. In addition to the microenvironment, there is also a connection between obesity, metabolic syndrome, and poor outcomes in breast cancer patients. Excess weight at diagnosis, weight gain following diagnosis and android body fat distribution all negatively impacts disease-free survival and local recurrence of breast cancer. Our hypothesis is: the Mediterranean diet will reduce excess weight, metabolic syndrome and improve the inflammatory profile, and therefore may offer the breast cancer survivor specific benefits.
Interventions
Dietary education will occur monthly for 6 months at the Clinical Research Centre in Grafton (85 Park Road, Grafton). Both BC-Med and Healthy Diet intervention will receive education (conducted by a Registered Dietitian and Dietetic student) and newsletters (sent by email). Face-to-face group education will occur once-monthly, with the newsletter sent two weeks thereafter.
Questionnaires will be administered and bloods taken at baseline, at completion of intervention (6 months) and 6 months
Dietary education will occur monthly for 6 months at the Clinical Research Centre in Grafton (85 Park Road, Grafton). Both BC-Med and Healthy Diet intervention will receive education (conducted by a Registered Dietitian and Dietetic student) and newsletters (sent by email). Face-to-face group education will occur once-monthly, with the newsletter sent two weeks thereafter. Questionnaires will be administered and bloods taken at baseline, at completion of intervention (6 months) and 6 months post intervention (12 months). Body weight, a blood test and questionnaires will be measured at baseline, post intervention and follow-up. Participants will be placed into one of three arms of a dietary intervention study. Each arm will consist of 15 women. Women on Arm 1 will be asked to adhere to a BC-MED diet and will receive dietary support and education. The BC-Med diet will consist of increasing the intake of olive oil, flaxseed oil, vegetables, fruit, legumes, fish, nuts, onions, leeks, garlic and turmeric while limiting the intake of red meat, butter, margarine, cream, carbonated drinks and pastries. The treatment diet will not restrict food volumes, just alter food types. Those placed in Arm 2 will be asked to adhere to a New Zealand healthy eating diet and will receive dietary support and education. The healthy eating diet will follow guidelines from the Nutrition Guidelines and will advocate fruit and vegetable consumption, low fat dairy, low fat meat, wholegrains and adequate hydration. The treatment diet will not restrict food volumes. An educational newsletter will be provided to the BC-MED and healthy eating groups once a month during the intervention. The intervention period will be 6 months. Changes in gene expression levels will be calculated and used to determine the pathways and networks affected by the change in dietary intake. Study participants will be genotyped in order to account for some of the risk associated with hereditary factors and differences in response to the diet. Diet adherance will be determined via attendance at education sessions, and on analysis of the food diaries completed mid way through the intervention, and change in PREDIMED questionnaire. Participants in each group will be matched for receptor expression and histology, breast cancer grade and use of hormone therapy. Research will be conducted at the Clinical Research Centre at Grafton campus of The University of Auckland.
Sponsors
The University of Auckland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Healthy volunteers
No
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.
Outcome results
None listed