Breast Cancer Diet Intervention Study (BCDIS)
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|ClinicalTrials.gov Identifier: NCT03886389|
Recruitment Status : Completed
First Posted : March 22, 2019
Last Update Posted : May 13, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Early-stage Breast Cancer Carbohydrate Engorgement Proliferation Insulin Resistance Estrogen Receptor-positive Breast Cancer||Dietary Supplement: PreOP||Not Applicable|
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.
- 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.
1. Proliferation in the tumor as measured by MAI.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|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|
|Official Title:||The Effects of Insulin and Insulin-related Characteristics, and Short-Term Low-glycemic and High-glycemic Carbohydrate Intervention on Breast Cancer Biomarkers and Survival|
|Actual Study Start Date :||June 12, 2009|
|Actual Primary Completion Date :||July 7, 2017|
|Actual Study Completion Date :||July 7, 2017|
Experimental: Carbohydrate/intervention group
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.
Dietary Supplement: PreOP
Mixture of Carbohydrates; standard amount designed for enhanced recovery after surgery (ERAS) i.e. preoperative carbohydrate loading before long standing surgery to enhance recovery.
No Intervention: Control group
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.
- Mitotic Activity Index (MAI) [ Time Frame: Trough completion of surgery of all included patients, an average of 1,5 years ]Proliferation in invasive front in tumor
- S-Insulin [ Time Frame: Analysed in serum samples at 5 time points; At inclusion (day 0), admission (day 10), preoperatively (day 11), postoperatively (day12) and at post operative visit (day 30) ]Secretion of insulin into serum; unit, mIE/L (milli international units pr liter)
- Well being after surgery [ Time Frame: Day 1,2,3,4,5,6 and 7 after surgery ]Patient Reported Outcome Measures (Questionaire)
- High Resolution Magnetic Resonance Spectroscopy (HR-MRS) profiling of specific metabolites [ Time Frame: Immediately after surgery: tumor is fresh frozen. High Resolution Magnetic Resonance Spectroscopy (HR-MRS) will be done in the fresh frozen tumor and deep frozen serum samples (=as for insulin characteristics) ]Metabolic profiling in the primary tumor and in the serum samples; measure content of lactate, glycine, choline, fatty acids and lipoproteins
- Relapse Free Survival [ Time Frame: Until 8 years (97 months of follow up) ]Time from surgery to a relapse (Loco-regional, contralateral and systemic) is experienced
- Breast Cancer Specific Survival [ Time Frame: 8 years follow-up (97 months of follow up) ]Time from surgery to dead of disease or all other causes of death.
- S-insulin c-peptide, [ Time Frame: Analysed in serum samples at 5 time points; At inclusion (day 0), admission (day 10), preoperatively (day 11), postoperatively (day12) and at post operative visit (day 30) ]Measure of total insulin secreted; unit, nM (nano molar)
- S-IGF1 [ Time Frame: Analysed in serum samples at 5 time points; At inclusion (day 0), admission (day 10), preoperatively (day 11), postoperatively (day12) and at post operative visit (day 30) ]Measure of Insulin growth factor type 1; unit, nM (nano molar)
- S-IGFBP3 [ Time Frame: Analysed in serum samples at 5 time points; At inclusion (day 0), admission (day 10), preoperatively (day 11), postoperatively (day12) and at post operative visit (day 30) ]Measure of Insulin growth factor binding protein 3; unit mg/L (milligram per liter)
- PR [ Time Frame: Trough completion of surgery of all included patients, an average of 1,5 years ]Expression of Progesteron Receptor in the primary tumor
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03886389
|Study Director:||Svein Skeie, PhD||Helse Stavanger HF; Stavanger University Hospital|