Breast Cancer Diet Intervention Study

NCT03886389 | Completed DMC

• 1 other identifier: 59
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

Breast Cancer; Estrogen receptor positive; Proliferation; Insulin resistance; PROMs; NMRI; RFS; BCSS

Outcome Measures

Primary Outcomes (1)

• Mitotic Activity Index (MAI)

  Proliferation in invasive front in tumor

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

Secondary Outcomes (9)

• S-Insulin

  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

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

• High Resolution Magnetic Resonance Spectroscopy (HR-MRS) profiling of specific metabolites

  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

  Until 8 years (97 months of follow up)

• Breast Cancer Specific Survival

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

Study Arms (2)

Carbohydrate/intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

PreOP 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.

Carbohydrate/intervention group

Eligibility Criteria

• Age: 25 Years - 100 Years
• Gender Eligibility Details: Breast cancer is 100 x more frequent in women than in men.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Helse Stavanger HF: lead

Related Publications (4)

• 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.

  PMID: 16135467 BACKGROUND

• 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.

  PMID: 18665447 BACKGROUND

• 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.

  PMID: 31801490 DERIVED

• 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.

  PMID: 31703648 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Insulin Resistance

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Svein Skeie, PhD

  Helse Stavanger HF; Stavanger University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor PhD

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

Study Record Dates

• First Submitted: March 19, 2019
• First Posted: March 22, 2019
• Study Start: June 12, 2009
• Primary Completion: July 7, 2017
• Study Completion: July 7, 2017
• Last Updated: May 13, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share