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Breast cancer patients receive 2 x preoperative carbohydrate loading \[PreOP(TM)\] before surgery; the 1st dose 18 hours before and 2nd dose 2-4 hours before surgery.

Breast cancer patients receive standard prep fasting procedure with nil food per os 8-10 hours before surgery, drinking tap water until 2 hours before surgery.

Mixture of Carbohydrates; standard amount designed for enhanced recovery after surgery (ERAS) i.e. preoperative carbohydrate loading before long standing surgery to enhance recovery.

PreOP

Svein Skeie, PhD

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.

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.

Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment

Breast cancer is 100 x more frequent in women than in men.

Breast Cancer Diet Intervention Study

The Effects of Insulin and Insulin-related Characteristics, and Short-Term Low-glycemic and High-glycemic Carbohydrate Intervention on Breast Cancer Biomarkers and Survival

All data will be available to all researches involved in the study included the statistician allocated to the study.

Secretion of insulin into serum; unit, mIE/L (milli international units pr liter)

Patient Reported Outcome Measures (Questionaire)

Metabolic profiling in the primary tumor and in the serum samples; measure content of lactate, glycine, choline, fatty acids and lipoproteins

Time from surgery to a relapse (Loco-regional, contralateral and systemic) is experienced

Time from surgery to dead of disease or all other causes of death.

Measure of total insulin secreted; unit, nM (nano molar)

Measure of Insulin growth factor type 1; unit, nM (nano molar)

Measure of Insulin growth factor binding protein 3; unit mg/L (milligram per liter)

Expression of Progesteron Receptor in the primary tumor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Breast Cancer Diet Intervention Study	NCT03886389	Early-stage Bre... Carbohydrate En... Proliferation Insulin Resista... Estrogen Recept...	PreOP	25 Years - 100 Years	Helse Stavanger HF
Breast Cancer Diet Intervention Study	NCT03886389	Early-stage Bre... Carbohydrate En... Proliferation Insulin Resista... Estrogen Recept...	PreOP	25 Years - 100 Years	Helse Stavanger HF

Spots Global Cancer Trial Database for carbohydrate engorgement