Breast Cancer Diet Intervention Study

It has been postulated that a "Western-style" diet, rich in carbohydrates (especially high glycemic carbohydrates) may have an effect on the incidence of breast cancer, and perhaps also prognosis. This may be mediated through the insulin-related pathways in breast cells which may show insulin-dependent proliferation, which may alter outcome.

Aims:

To study:

• The inter-patient variation in insulin and insulin-related characteristics in the blood taken just before the operation from breast cancer patients, on a usual pre-operative fasting schedule;
• The influence of the variation in insulin and insulin-related characteristics on proliferation and other cell biological features in the breast cancers of these patients;
• Whether 4 and 18-hours pre-operative hyperglycaemic glucose loading (to reduce postoperative insulin resistance) influences proliferation (Mitotic Activity Index (MAI) and other cell biological features in breast cancer*
• The influence of the short-term effect of a pre-operative low-glycaemic carbohydrate isocaloric diet on proliferation and other cell biological features of the primary breast cancer cells (Low-glycemic isocaloric diet intervention study);
• Epidemiological risk factors: The correlation between epidemiological risk factors, insulin and insulin-related characteristics, proliferation, cell biological features and other biomarkers in breast cancer patients.
• Estrogen Receptor positive tumors will be analyses separately.
• Relapse free survival
• Breast Cancer Specific Survival.

The Short-term effect of carbohydrates will be assessed in a randomized intervention study, where 30 patients receive oral carbohydrates 18 and 4 hours before surgery and 30 patients receive fasting procedure/water.

Primary Outcome

• Proliferation in the tumor as measured by MAI.

Secondary Outcomes:

• Serum insulin characteristics (S-insulin, S- insulin c-peptide, S-IGF and S-IGFBP3) will be measured at various peri-surgical timepoints
• Changes in metabolic profile* in the tumor and in serum samples
• Patient Reported Outcome Measures (PROM) on well being
• Relapse free survival
• Breast Cancer Specific Survival

• Metabolic profile assessed by High Resolution Magnetic Resonance Spectroscopy (HR-MRS) in the tumor and in serum samples.

Inclusion criteria

• All consecutive operable patients in 2009-2010, with a clinical and/or radiologic and/or cytologic diagnosis of primary breast cancer, unless the exclusion criteria apply.

Exclusion criteria

• Non-operable patients (i.e" patients with T3-4 (>5 cm) disease or distant metastases at the time of operation).
• All patients who refuse to participate.
• All patients with DCIS, micro-invasive cancer < 2mm diameter or tumors with histologic poor-quality material.
• Co-morbidity (Insulin dependent Diabetes Mellitus, Cushing syndrome, previous or concurrent cancers except CIN and non-melanomatous skin cancer.
• Mental inability to participate.
• Persons allergic to one of the compounds in any of the two diets.