Breast Cancer Diet Intervention Study
Condition: Early-stage Breast Cancer; Carbohydrate Engorgement; Proliferation; Insulin Resistance; Estrogen Receptor-positive Breast Cancer
MeSH terms: Breast Neoplasms; Insulin Resistance
Study type: Interventional

Summary: 
      The investigators have already proven that Mitotic Activity Index (MAI)is the most robust
      measure of proliferation in breast cancer tissue.

      The purpose was to study whether 18 and 2-4 hours pre-operative per-oral carbohydrate loading
      (often given in gastrointestinal surgery i.e. enhanced recovery after surgery=ERAS)
      influences proliferation in the tumor, serum insulin characteristics, metabolic profile and
      survival.
    

Detailed description: 
      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:

        1. 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;

        2. 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;

        3. 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*

        4. 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);

        5. 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.

        6. Estrogen Receptor positive tumors will be analyses separately.

        7. Relapse free survival

        8. 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

      1. Proliferation in the tumor as measured by MAI.

      Secondary Outcomes:

        1. Serum insulin characteristics (S-insulin, S- insulin c-peptide, S-IGF and S-IGFBP3) will
           be measured at various peri-surgical timepoints

        2. Changes in metabolic profile* in the tumor and in serum samples

        3. Patient Reported Outcome Measures (PROM) on well being

        4. Relapse free survival

        5. Breast Cancer Specific Survival

             -  Metabolic profile assessed by High Resolution Magnetic Resonance Spectroscopy
                (HR-MRS) in the tumor and in serum samples.
    

Intervention name(s): PreOP
Intervention type(s): Dietary Supplement
Intervention description(s): Mixture of Carbohydrates; standard amount designed for enhanced recovery after surgery (ERAS) i.e. preoperative carbohydrate loading before long standing surgery to enhance recovery.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Breast Cancer; Estrogen receptor positive; Proliferation; Insulin resistance; PROMs; NMRI; RFS; BCSS