Evidence map›Paper›PMID 26438237›Full record

Trial reportBMC cancer2015

The effects of short-term fasting on tolerance to (neo) adjuvant chemotherapy in HER2-negative breast cancer patients: a randomized pilot study.

Stefanie de Groot, Maaike P G Vreeswijk, Marij J P Welters, Gido Gravesteijn, Jan J W A Boei, Anouk Jochems, Daniel Houtsma, Hein Putter, Jacobus J M van der Hoeven, Johan W R Nortier and 2 more

6 registry-linked trialsOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC cancer, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 6 registered trials, which are not on this map. Cited by 139 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
139citing papers in PubMed, 9 pooled it
7.4field-weighted citation impact, top 2% 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.

NCT01304251 nacompletednot on this map

Effects of Short-term Fasting on Tolerance to Adjuvant Chemotherapy in Breast Cancer Patients

TypeinterventionalSponsorLeiden University Medical CenterRan2011 to 2015Enrolled13ConditionsBreast CancerArmsShort-term fasting, Healthy nutrition
NCT03340935 nacompletednot on this mapstarted 2017, after this paper: background citation

Safety, Feasibility and Metabolic Effects of the Fasting Mimicking Diet (FMD) in Cancer Patients

TypeinterventionalSponsorFilippo de BraudRan2017 to 2020Enrolled101ConditionsMalignant Neoplasm, CancerArmsFasting mimicking diet
NCT03454282 naunknown statusnot on this mapstarted 2018, after this paper: background citation

Impact of Dietary Intervention on Tumor Immunity: the DigesT Trial.

TypeinterventionalSponsorFondazione IRCCS Istituto Nazionale dei Tumori, MilanoRan2018 to 2020Enrolled100ConditionsBreast Cancer, Melanoma, MalignantArmsFMD
NCT03709147 phase2unknown statusnot on this mapstarted 2018, after this paper: background citation

Exploiting Metformin Plus/Minus Cyclic Fasting Mimicking Diet (FMD) to Improve the Efficacy of First Line Chemo-immunotherapy in Advanced LKB1-inactive Lung Adenocarcinoma

TypeinterventionalSponsorMarina GarassinoRan2018 to 2023Enrolled64ConditionsAdvanced LKB1-inactive Lung AdenocarcinomaArmsMetformin Hydrochloride, Cisplatin, Carboplatin, Pemetrexed, Fasting-mimicking diet
NCT04027478 naunknown statusnot on this mapstarted 2019, after this paper: background citation

Can Fasting Decrease the Side Effects of Chemotherapy?

TypeinterventionalSponsorSutter HealthRan2019 to 2021Enrolled39ConditionsChemotherapy Effect, Chemotherapeutic Toxicity, FastingArmsFMD
NCT04248998 phase2unknown statusnot on this mapstarted 2020, after this paper: background citation

Targeting Triple Negative BREAst Cancer Metabolism With a Combination of Chemotherapy and a Diet Mimicking FASTing Plus/Minus Metformin in the Preoperative Setting: the BREAKFAST Trial

TypeinterventionalSponsorFondazione IRCCS Istituto Nazionale dei Tumori, MilanoRan2020 to 2024Enrolled30ConditionsTriple-negative Breast CancerArmsFasting-mimicking diet, Metformin, Preoperative chemotherapy
3 · Its place in the literature

Who cites it

139 citing papers in PubMed, 9 syntheses or guidelines pooled it, 250 citations in OpenAlex.

  1. Pooled it
  2. Impact of intermittent fasting on patients with cancer undergoing chemotherapy and/or targeted therapies: a systematic review of the literature.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2025
    Pooled it
  3. Pooled it
  4. Pooled it
  5. Guideline
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  7. 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
  8. Pooled it
  9. Food Intake During Cancer Therapy: A Systematic Review.American journal of clinical oncology · 2020
    Pooled it
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79 more citing papers are in PubMed but not listed here.

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

12 authors at 2 institutions in 1 country.

Stefanie de GrootDepartment of Medical Oncology, Leiden University Medical Center, Albinusdreef 2, P.O. Box 9600, 2300, RC, Leiden, The Netherlands. S.de_Groot2@lumc.nl.
Maaike P G VreeswijkDepartment of Human Genetics, Leiden University Medical Center, Leiden, The Netherlands. M.P.G.Vreeswijk@lumc.nl.
Marij J P WeltersDepartment of Medical Oncology, Leiden University Medical Center, Albinusdreef 2, P.O. Box 9600, 2300, RC, Leiden, The Netherlands. M.J.P.SchoenmaekersWelters@lumc.nl.
Gido GravesteijnDepartment of Human Genetics, Leiden University Medical Center, Leiden, The Netherlands. G.Gravesteijn@lumc.nl.
Jan J W A BoeiDepartment of Human Genetics, Leiden University Medical Center, Leiden, The Netherlands. J.J.W.A.Boei@lumc.nl.
Anouk JochemsDepartment of Medical Oncology, Leiden University Medical Center, Albinusdreef 2, P.O. Box 9600, 2300, RC, Leiden, The Netherlands. A.Jochems@lumc.nl.
Daniel HoutsmaDepartment of Internal Medicine, Haga Hospital, The Hague, The Netherlands. D.Houtsma@lumc.nl.
Hein PutterDepartment of Medical Statistics, Leiden University Medical Center, Leiden, The Netherlands. H.Putter@lumc.nl.
Jacobus J M van der HoevenDepartment of Medical Oncology, Leiden University Medical Center, Albinusdreef 2, P.O. Box 9600, 2300, RC, Leiden, The Netherlands. J.J.M.van_der_Hoeven@lumc.nl.
Johan W R NortierDepartment of Medical Oncology, Leiden University Medical Center, Albinusdreef 2, P.O. Box 9600, 2300, RC, Leiden, The Netherlands. J.W.R.Nortier@lumc.nl.
Hanno PijlDepartment of Endocrinology, Leiden University Medical Center, Leiden, The Netherlands. H.Pijl@lumc.nl.
Judith R KroepDepartment of Medical Oncology, Leiden University Medical Center, Albinusdreef 2, P.O. Box 9600, 2300, RC, Leiden, The Netherlands. J.R.Kroep@lumc.nl.
Leiden University Medical Center · NLHaga Hospital · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPreclinical evidence shows that short-term fasting (STF) protects healthy cells against side effects of chemotherapy and makes cancer cells more vulnerable to it. This pilot study examines the feasibility of STF and its effects on tolerance of chemotherapy in a homogeneous patient group with early breast cancer (BC).

methodsEligible patients had HER2-negative, stage II/III BC. Women receiving (neo)-adjuvant TAC (docetaxel/doxorubicin/cyclophosphamide) were randomized to fast 24 h before and after commencing chemotherapy, or to eat according to the guidelines for healthy nutrition. Toxicity in the two groups was compared. Chemotherapy-induced DNA damage in peripheral blood mononuclear cells (PBMCs) was quantified by the level of γ-H2AX analyzed by flow cytometry.

resultsThirteen patients were included of whom seven were randomized to the STF arm. STF was well tolerated. Mean erythrocyte- and thrombocyte counts 7 days post-chemotherapy were significantly higher (P = 0.007, 95 % CI 0.106-0.638 and P = 0.00007, 95 % CI 38.7-104, respectively) in the STF group compared to the non-STF group. Non-hematological toxicity did not differ between the groups. Levels of γ-H2AX were significantly increased 30 min post-chemotherapy in CD45 + CD3- cells in non-STF, but not in STF patients.

conclusionsSTF during chemotherapy was well tolerated and reduced hematological toxicity of TAC in HER2-negative BC patients. Moreover, STF may reduce a transient increase in, and/or induce a faster recovery of DNA damage in PBMCs after chemotherapy. Larger studies, investigating a longer fasting period, are required to generate more insight into the possible benefits of STF during chemotherapy.

trial registrationClinicalTrials.gov: NCT01304251 , March 2011.

Indexed as

FastingAdultAgedAntineoplastic Combined Chemotherapy ProtocolsBiomarkersBreast NeoplasmsDNA DamageErb-b2 Receptor Tyrosine KinasesFemaleHistonesHumansLeukocytes, MononuclearMiddle AgedNeoadjuvant TherapyNeoplasm GradingNeoplasm StagingBiomarkersErb-b2 Receptor Tyrosine KinasesH2AX protein, humanHistones

Identifiers

PMID26438237
PMCPMC4595051
OpenAlexW1868131768

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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.