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Trial registered on ANZCTR


Registration number
ACTRN12616000003471
Ethics application status
Approved
Date submitted
14/12/2015
Date registered
6/01/2016
Date last updated
8/12/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Improving health in breast cancer survivors, a novel dietary approach
Scientific title
Will an adapted Mediterranean diet (BC-MED) improve health in breast cancer survivors?
Secondary ID [1] 288118 0
None
Universal Trial Number (UTN)
U1111-1174-8542
Trial acronym
BC-Med
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 296993 0
Condition category
Condition code
Diet and Nutrition 297245 297245 0 0
Other diet and nutrition disorders
Cancer 297307 297307 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 293426 0
Treatment: Other
Intervention code [2] 293427 0
Lifestyle
Comparator / control treatment
Women in Arm 3 will be asked to continue as usual and will receive no education or support until study completion. The no treatment control will be provided all the education material of the most successful group once the study has been completed.
Control group
Active

Outcomes
Primary outcome [1] 296825 0
Weight. Measured on calibrated, ISAK accredited body weight scales in the clinical centre by an ISAK accredited anthropometrist.
Timepoint [1] 296825 0
Completion of intervention (6 months), and 6 months post intervention (12 months)
Primary outcome [2] 296826 0
Blood lipids (LDL-chol, Total cholesterol).
Timepoint [2] 296826 0
Completion of intervention (6 months), and 6 months post intervention (12 months)
Primary outcome [3] 296827 0
HbA1c (whole blood), assessed using ion exchange chromotography
Timepoint [3] 296827 0
Completion of intervention (6 months), and 6 months post intervention (12 months)
Secondary outcome [1] 319473 0
DNA damage (The comet assay)
Timepoint [1] 319473 0
Completion of intervention (6 months), and 6 months post intervention (12 months)
Secondary outcome [2] 319474 0
Quality of life questionnaire (FACT-B)
Timepoint [2] 319474 0
Completion of intervention (6 months), and 6 months post intervention (12 months)
Secondary outcome [3] 319475 0
Dietary intake questionnaire (PREDIMED)
Timepoint [3] 319475 0
Completion of intervention (6 months), and 6 months post intervention (12 months)
Secondary outcome [4] 319588 0
C-RP (serum sample)
Timepoint [4] 319588 0
Completion of intervention (6 months) and 6 months post intervention (12 months)
Secondary outcome [5] 319589 0
Fatty acid profile (FAMES assay)
Timepoint [5] 319589 0
At completion of trial (6 months) and 6 months post intervention (12 months)

Eligibility
Key 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.
Minimum age
50 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Each participant will be allocated an identification number from 1-45. The participants will be block allocated to one of three groups. Set 1 will be arm 1, set 2 arm 2 and set 3 no treatment control. Allocation to treatment will occur via central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
On-line randomiser (www.randomizer.org) will be used to perform a block allocation, ensuring (to our best effect) equal weighting to breast cancer grade, receptor expression and use of hormone therapy.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The study is powered for the primary outcome, weight loss, at 80% power to detect a 3% weight loss (p<0.05) in the intervention group, yielding a target sample size of ten participants per group. Studies of similar design have experienced 25% drop out, therefore 15 participants per group will be recruited. Randomisation will be determined a priori by a researcher not involved with the intervention. Group assignment will not be revealed to the participant until the completion of all baseline testing.
Data will be analysed following log transformation to reduce the effects of non-uniformity of error and express outcomes as percent. The two-tailed Student’s t distribution will be used to analyse pre-post changes. We will use the standardised (Cohen) change of 0.20 times the between-subject standard deviation for the baseline measure in the control condition as the substantial threshold; a modified classification system (trivial, 0.0–0.2; small, 0.2–0.6; moderate, 0.6–1.2; large, 1.2–2.0; very large, >2.0) will be used to interpret the magnitude of the standardized change. An effect will be deemed unclear if the confidence interval overlapped both the upper and the lower thresholds for substantiveness. Otherwise, the likelihood of a substantial increase or decrease will be classified as follows: <0.5%, almost certainly not; 0.5%–5%, very unlikely; 5%–25%, unlikely; 25%–75%, possible; 75%–95%, likely; 95%–99.5%, very likely; and >99.5%, almost certain. When the majority (>50%) of the confidence interval lies between the threshold for substantially positive and negative effects, the likelihood of the effect being trivial (negligible) will be qualified.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
14/12/2015
Date of last participant enrolment
Anticipated
31/03/2016
Actual
5/02/2016
Date of last data collection
Anticipated
Actual
1/09/2016
Sample size
Target
45
Accrual to date
Final
38
Recruitment outside Australia
Country [1] 7418 0
New Zealand
State/province [1] 7418 0
Auckland

Funding & Sponsors
Funding source category [1] 292553 0
University
Name [1] 292553 0
Health Programme Seeding Fund, The University of Auckland
Country [1] 292553 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
85 Park Road,
Grafton, Auckland
New Zealand, 1142
Country
New Zealand
Secondary sponsor category [1] 291272 0
None
Name [1] 291272 0
None
Address [1] 291272 0
N/A
Country [1] 291272 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294029 0
Health and Disability Northern Ethics Committee
Ethics committee address [1] 294029 0
Ethics committee country [1] 294029 0
New Zealand
Date submitted for ethics approval [1] 294029 0
06/10/2015
Approval date [1] 294029 0
06/11/2015
Ethics approval number [1] 294029 0
15/STH/184

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 62114 0
Dr Andrea Braakhuis
Address 62114 0
The University of Auckland
Faculty of Medical and Health Science
85 Park Road
Grafton, Auckland,
New Zealand, 1142
Country 62114 0
New Zealand
Phone 62114 0
+64 22 350 2926
Fax 62114 0
Email 62114 0
[email protected]
Contact person for public queries
Name 62115 0
Andrea Braakhuis
Address 62115 0
The University of Auckland
Faculty of Medical and Health Science
85 Park Road
Grafton, Auckland,
New Zealand, 1142
Country 62115 0
New Zealand
Phone 62115 0
+64223502926
Fax 62115 0
Email 62115 0
[email protected]
Contact person for scientific queries
Name 62116 0
Andrea Braakhuis
Address 62116 0
The University of Auckland
Faculty of Medical and Health Science
85 Park Road
Grafton, Auckland,
New Zealand, 1142
Country 62116 0
New Zealand
Phone 62116 0
+64223502926
Fax 62116 0
Email 62116 0
[email protected]

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