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BMC Cancer
Published in: BMC Cancer 1/2019

Open Access 01-12-2019 | Breast Cancer | Research article

Influence of pre-operative oral carbohydrate loading vs. standard fasting on tumor proliferation and clinical outcome in breast cancer patients ─ a randomized trial

Authors: Tone Hoel Lende, Marie Austdal, Anne Elin Varhaugvik, Ivar Skaland, Einar Gudlaugsson, Jan Terje Kvaløy, Lars A. Akslen, Håvard Søiland, Emiel A. M. Janssen, Jan P. A. Baak

Published in: BMC Cancer | Issue 1/2019

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Abstract

Background

Conflicting results have been reported on the influence of carbohydrates in breast cancer.

Objective

To determine the influence of pre-operative per-oral carbohydrate load on proliferation in breast tumors.

Design

Randomized controlled trial.

Setting

University hospital with primary and secondary care functions in South-West Norway.

Patients

Sixty-one patients with operable breast cancer from a population-based cohort.

Intervention

Per-oral carbohydrate load (preOp™) 18 and 2–4 h before surgery (n = 26) or standard pre-operative fasting with free consumption of tap water (n = 35).

Measurements

The primary outcome was post-operative tumor proliferation measured by the mitotic activity index (MAI). The secondary outcomes were changes in the levels of serum insulin, insulin-c-peptide, glucose, IGF-1, and IGFBP3; patients’ well-being, and clinical outcome over a median follow-up of 88 months (range 33–97 months).

Results

In the estrogen receptor (ER) positive subgroup (n = 50), high proliferation (MAI ≥ 10) occurred more often in the carbohydrate group (CH) than in the fasting group (p = 0.038). The CH group was more frequently progesterone receptor (PR) negative (p = 0.014). The CH group had a significant increase in insulin (+ 24.31 mIE/L, 95% CI 15.34 mIE/L to 33.27 mIE/L) and insulin c-peptide (+ 1.39 nM, 95% CI 1.03 nM to 1.77 nM), but reduced IGFBP3 levels (− 0.26 nM; 95% CI − 0.46 nM to − 0.051 nM) compared to the fasting group. CH-intervention ER-positive patients had poorer relapse-free survival (73%) than the fasting group (100%; p = 0.012; HR = 9.3, 95% CI, 1.1 to 77.7). In the ER-positive patients, only tumor size (p = 0.021; HR = 6.07, 95% CI 1.31 to 28.03) and the CH/fasting subgrouping (p = 0.040; HR = 9.30, 95% CI 1.11 to 77.82) had independent prognostic value. The adverse clinical outcome of carbohydrate loading occurred only in T2 patients with relapse-free survival of 100% in the fasting group vs. 33% in the CH group (p = 0.015; HR = inf). The CH group reported less pain on days 5 and 6 than the control group (p <  0.001) but otherwise exhibited no factors related to well-being.

Limitation

Only applicable to T2 tumors in patients with ER-positive breast cancer.

Conclusions

Pre-operative carbohydrate load increases proliferation and PR-negativity in ER-positive patients and worsens clinical outcome in ER-positive T2 patients.

Trial registration

CliniTrials.gov; NCT03886389. Retrospectively registered March 22, 2019.
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Metadata
Title
Influence of pre-operative oral carbohydrate loading vs. standard fasting on tumor proliferation and clinical outcome in breast cancer patients ─ a randomized trial
Authors
Tone Hoel Lende
Marie Austdal
Anne Elin Varhaugvik
Ivar Skaland
Einar Gudlaugsson
Jan Terje Kvaløy
Lars A. Akslen
Håvard Søiland
Emiel A. M. Janssen
Jan P. A. Baak
Publication date
01-12-2019
Publisher
BioMed Central
Published in
BMC Cancer / Issue 1/2019
Electronic ISSN: 1471-2407
DOI
https://doi.org/10.1186/s12885-019-6275-z

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