Breast Cancer Diet Intervention Study

NCT ID: NCT03886389

Last Updated: 2019-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-12
• Study Completion Date: 2017-07-07

Brief 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.

Conditions

Early-stage Breast Cancer; Carbohydrate Engorgement; Proliferation; Insulin Resistance; Estrogen Receptor-positive Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

PreOP

Intervention Type: DIETARY_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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Exclusion Criteria

1. Non-operable patients (i.e" patients with T3-4 (>5 cm) disease or distant metastases at the time of operation).

2. All patients who refuse to participate.

3. All patients with DCIS, micro-invasive cancer < 2mm diameter or tumors with histologic poor-quality material.

4. Co-morbidity (Insulin dependent Diabetes Mellitus, Cushing syndrome, previous or concurrent cancers except CIN and non-melanomatous skin cancer.

5. Mental inability to participate.

6. Persons allergic to one of the compounds in any of the two diets.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Helse Stavanger HF

OTHER_GOV

Sponsor Role: lead

Responsible Party

Haavard Soiland

Professor PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Svein Skeie, PhD

Role: STUDY_DIRECTOR

Helse Stavanger HF; Stavanger University Hospital

References

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.

Reference Type: BACKGROUND

PMID: 16135467 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18665447 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31801490 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31703648 (View on PubMed)

Other Identifiers

59

Identifier Type: -

Identifier Source: org_study_id