An interventional study of PreOP in Early-stage Breast Cancer, Carbohydrate Engorgement and Proliferation, sponsored by Helse Stavanger HF. Completed. Open to female participants aged 25 Years to 100 Years. Per ClinicalTrials.gov, last updated 2019-05-13.
Sponsored by Helse Stavanger HF · Not applicable, Interventional, and Basic science
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:
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
Secondary Outcomes:
Breast Cancer Specific Survival
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 80 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Helse Stavanger HF is the lead sponsor of 93 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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.
Mitotic Activity Index (MAI)
Proliferation in invasive front in tumor
Time frame: Trough completion of surgery of all included patients, an average of 1,5 years
S-Insulin
Secretion of insulin into serum; unit, mIE/L (milli international units pr liter)
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)
Well being after surgery
Patient Reported Outcome Measures (Questionaire)
Time frame: Day 1,2,3,4,5,6 and 7 after surgery
High Resolution Magnetic Resonance Spectroscopy (HR-MRS) profiling of specific metabolites
Metabolic profiling in the primary tumor and in the serum samples; measure content of lactate, glycine, choline, fatty acids and lipoproteins
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)
Relapse Free Survival
Time from surgery to a relapse (Loco-regional, contralateral and systemic) is experienced
Time frame: Until 8 years (97 months of follow up)
Breast Cancer Specific Survival
Time from surgery to dead of disease or all other causes of death.
Time frame: 8 years follow-up (97 months of follow up)
S-insulin c-peptide,
Measure of total insulin secreted; unit, nM (nano molar)
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)
S-IGF1
Measure of Insulin growth factor type 1; unit, nM (nano molar)
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)
S-IGFBP3
Measure of Insulin growth factor binding protein 3; unit mg/L (milligram per liter)
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)
PR
Expression of Progesteron Receptor in the primary tumor
Time frame: Trough completion of surgery of all included patients, an average of 1,5 years
No study locations are listed for this record.
Plan to share: No — All data will be available to all researches involved in the study included the statistician allocated to the study.
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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Helse Stavanger HF