Evidence map›Paper›PMID 31703648›Full record

Trial reportBMC cancer2019

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

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

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC cancer, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03886389 (The Effects of Insulin and Insulin-related Characteristics, and Short-Term Low-glycemic and High-glycemic Carbohydrate Intervention on Breast Cancer Biomarkers and Survival), which is not on this map. Cited by 14 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 4 pooled it
1.3field-weighted citation impact, top 19% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03886389 nacompletednot on this map

The Effects of Insulin and Insulin-related Characteristics, and Short-Term Low-glycemic and High-glycemic Carbohydrate Intervention on Breast Cancer Biomarkers and Survival

TypeinterventionalSponsorHelse Stavanger HFRan2009 to 2017Enrolled80ConditionsEarly-stage Breast Cancer, Carbohydrate Engorgement, Proliferation, Insulin ResistanceArmsPreOP
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 4 syntheses or guidelines pooled it, 21 citations in OpenAlex.

  1. Pooled it
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  4. Fasting during cancer treatment: a systematic review.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2023
    Pooled it
  5. Trial
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  8. The effect of preoperative oral carbohydrate on the perioperative period of fibula free flap surgery in patients with oral cancer: a retrospective study.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2025
    Article
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  10. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 2 institutions in 2 countries.

Tone Hoel LendeDepartment of Breast & Endocrine Surgery, Stavanger University Hospital, Helse Stavanger HF, P.O. Box 8100, N-4068, Stavanger, Norway. leth@sus.no.ORCID http://orcid.org/0000-0002-7829-8885
Marie AustdalDepartment of Research, Stavanger University Hospital, Helse Stavanger HF, P.O. Box 8100, N-4068, Stavanger, Norway.
Anne Elin VarhaugvikDepartment of Pathology, Stavanger University Hospital, Helse Stavanger HF, P.O. Box 8100, N-4068, Stavanger, Norway.
Ivar SkalandDepartment of Pathology, Stavanger University Hospital, Helse Stavanger HF, P.O. Box 8100, N-4068, Stavanger, Norway.
Einar GudlaugssonDepartment of Pathology, Stavanger University Hospital, Helse Stavanger HF, P.O. Box 8100, N-4068, Stavanger, Norway.
Jan Terje KvaløyDepartment of Research, Stavanger University Hospital, Helse Stavanger HF, P.O. Box 8100, N-4068, Stavanger, Norway.
Lars A AkslenCentre for Cancer Biomarkers CCBIO, Department of Clinical Medicine, Faculty of Medicine and Dentistry, University of Bergen, Jonas Lies vei 87, N-5012, Bergen, Norway.
Håvard SøilandDepartment of Breast & Endocrine Surgery, Stavanger University Hospital, Helse Stavanger HF, P.O. Box 8100, N-4068, Stavanger, Norway.
Emiel A M JanssenDepartment of Pathology, Stavanger University Hospital, Helse Stavanger HF, P.O. Box 8100, N-4068, Stavanger, Norway.
Jan P A BaakDepartment of Pathology, Stavanger University Hospital, Helse Stavanger HF, P.O. Box 8100, N-4068, Stavanger, Norway.
Stavanger University Hospital · NOUniversity of Bergen · NO

Funding

Folke Hermansen Foundation (N) 2012Inge Steensland Foundation, Stavanger (N) 2011Marathon Oil 2009
6 · The paper itself

Abstract

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

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

designRandomized controlled trial.

settingUniversity hospital with primary and secondary care functions in South-West Norway. PATIENTS: Sixty-one patients with operable breast cancer from a population-based cohort.

interventionPer-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).

resultsIn 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.

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

trial registrationCliniTrials.gov; NCT03886389. Retrospectively registered March 22, 2019.

Indexed as

Cell ProliferationPreoperative PeriodBlood GlucoseBreast NeoplasmsDiet, Carbohydrate LoadingDisease-Free SurvivalFastingFemaleFollow-Up StudiesHospitals, UniversityHumansInsulinMiddle AgedNorwayPrognosisQuality of LifeBlood GlucoseInsulinReceptors, EstrogenReceptors, ProgesteroneBreast cancerBreast cancer-specific survivalCarbohydrate loadIGF-1IGFBP3InsulinInsulin c-peptideProliferationRelapse-free survivalTumor size

Identifiers

PMID31703648
PMCPMC6842165
OpenAlexW2983285015

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.