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AzTrials

Early-stage Breast CancerBCDISNCT03886389

Breast Cancer Diet Intervention Study

A study testing PreOP in people with Early-stage Breast Cancer and Carbohydrate Engorgement, run by Helse Stavanger HF.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 25 to 100 years, women only
What is being tested?
PreOP
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
No sites listed yet
Study dates
12 Jun 2009to 7 Jul 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 100 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

About this study

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

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.

Read the 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.
Being tested
PreOP
Keywords
Breast Cancer, Estrogen receptor positive, Proliferation, Insulin resistance, PROMs, NMRI, RFS, BCSS
Medical subject headings
Breast Neoplasms, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PreOPDietary supplement

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

Study groups in NCT03886389
Study groupRoleWhat they receive
Carbohydrate/intervention groupExperimentalBreast 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.
Receives: Dietary Supplement: PreOP
Control groupNo interventionBreast 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mitotic Activity Index (MAI)

    Proliferation in invasive front in tumor

    Measured: Trough completion of surgery of all included patients, an average of 1,5 years

Secondary outcomes (9)

  1. S-Insulin

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

    Measured: 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)

  2. Well being after surgery

    Patient Reported Outcome Measures (Questionaire)

    Measured: Day 1,2,3,4,5,6 and 7 after surgery

  3. 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

    Measured: 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)

  4. Relapse Free Survival

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

    Measured: Until 8 years (97 months of follow up)

  5. Breast Cancer Specific Survival

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

    Measured: 8 years follow-up (97 months of follow up)

  6. S-insulin c-peptide,

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

    Measured: 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)

  7. S-IGF1

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

    Measured: 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)

  8. S-IGFBP3

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

    Measured: 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)

  9. PR

    Expression of Progesteron Receptor in the primary tumor

    Measured: Trough completion of surgery of all included patients, an average of 1,5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2019
  2. Study start12 Jun 2009
  3. Primary completion7 Jul 2017
  4. Study completion7 Jul 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Model description
Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03886389
Sponsor's protocol ID
59
Acronym
BCDIS
Status last verified
May 2019
First submitted
19 Mar 2019
Last updated
13 May 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: All data will be available to all researches involved in the study included the statistician allocated to the study.

Publications

  • Baak JP, van Diest PJ, Voorhorst FJ, van der Wall E, Beex LV, Vermorken JB, Janssen EA. Prospective multicenter validation of the independent prognostic value of the mitotic activity index in lymph node-negative breast cancer patients younger than 55 years. J Clin Oncol. 2005 Sep 1;23(25):5993-6001. doi: 10.1200/JCO.2005.05.511.

    PubMed 16135467

  • Baak JP, Gudlaugsson E, Skaland I, Guo LH, Klos J, Lende TH, Soiland H, Janssen EA, Zur Hausen A. Proliferation is the strongest prognosticator in node-negative breast cancer: significance, error sources, alternatives and comparison with molecular prognostic markers. Breast Cancer Res Treat. 2009 May;115(2):241-54. doi: 10.1007/s10549-008-0126-y. Epub 2008 Jul 30.

    PubMed 18665447

  • Lende TH, Austdal M, Bathen TF, Varhaugvik AE, Skaland I, Gudlaugsson E, Egeland NG, Lunde S, Akslen LA, Jonsdottir K, Janssen EAM, Soiland H, Baak JPA. Metabolic consequences of perioperative oral carbohydrates in breast cancer patients - an explorative study. BMC Cancer. 2019 Dec 4;19(1):1183. doi: 10.1186/s12885-019-6393-7.

    PubMed 31801490

  • Lende TH, Austdal M, Varhaugvik AE, Skaland I, Gudlaugsson E, Kvaloy JT, Akslen LA, Soiland H, Janssen EAM, Baak JPA. Influence of pre-operative oral carbohydrate loading vs. standard fasting on tumor proliferation and clinical outcome in breast cancer patients horizontal line a randomized trial. BMC Cancer. 2019 Nov 8;19(1):1076. doi: 10.1186/s12885-019-6275-z.

    PubMed 31703648

Questions about this trial

What is this clinical trial studying?

A study testing PreOP in people with Early-stage Breast Cancer and Carbohydrate Engorgement, run by Helse Stavanger HF.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 May 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mitotic Activity Index (MAI) (time frame: Trough completion of surgery of all included patients, an average of 1,5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03886389, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2019.

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