Evidence map›Paper›PMID 33179154›Full record

Trial reportBreast cancer research and treatment2021

Quality of life and illness perceptions in patients with breast cancer using a fasting mimicking diet as an adjunct to neoadjuvant chemotherapy in the phase 2 DIRECT (BOOG 2013-14) trial.

Rieneke T Lugtenberg, Stefanie de Groot, Ad A Kaptein, Maarten J Fischer, Elma Meershoek-Klein Kranenbarg, Marjolijn Duijm-de Carpentier, Danielle Cohen, Hiltje de Graaf, Joan B Heijns, Johanneke E A Portielje and 12 more

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Breast cancer research and treatment, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 41 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
41citing papers in PubMed, 9 pooled it
3.6field-weighted citation impact, top 6% 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.

NCT02126449 phase2 / phase3completednot on this map

DIetary REstriction as an Adjunct to Neoadjuvant ChemoTherapy for HER2 Negative Breast Cancer

TypeinterventionalSponsorLeiden University Medical CenterRan2014 to 2018Enrolled131ConditionsFasting Mimicking Diet, Breast Cancer, Neoadjuvant Chemotherapy, Pathological Complete ResponseArmsFasting mimicking diet
NCT05503108 phase3suspendednot on this mapstarted 2023, after this paper: background citation

DIRECT-2: Fasting Mimicking Diet Program to ImpRovE ChemoTherapy in HR+, HER2- Breast Cancer

TypeinterventionalSponsorLeiden University Medical CenterRan2023 to 2024Enrolled10ConditionsFasting Mimicking Diet, HER2-negative Breast Cancer, Hormone Receptor-positive Breast Cancer, Pathological Complete ResponseArmsFasting Mimicking diet program
3 · Its place in the literature

Who cites it

41 citing papers in PubMed, 9 syntheses or guidelines pooled it, 58 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
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  4. Effects of food-based interventions in the management of chemoradiotherapy-induced nausea and vomiting: a systematic review.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2023
    Pooled it
  5. Pooled it
  6. Pooled it
  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. Pooled it
  10. Trial
  11. Article
  12. Article
  13. Article
  14. Article
  15. Article
  16. [The Role of Fasting-Mimicking Diet in Cancer Therapy: Mechanisms, Challenges, and Clinical Prospects].Sichuan da xue xue bao. Yi xue ban = Journal of Sichuan University. Medical science edition · 2025
    Review
  17. Review
  18. Review
  19. Review
  20. Charting cancer's course: revealing the role of diet, exercise, and the microbiome in cancer evolution and immunotherapy response.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2025
    Review
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

22 authors at 8 institutions in 3 countries.

Rieneke T Lugtenberg *Department of Medical Oncology, Leiden University Medical Center, Albinusdreef 2, Leiden, P.O. Box 9600, 2300 RC, Leiden, The Netherlands.
Stefanie de Groot *Department of Medical Oncology, Leiden University Medical Center, Albinusdreef 2, Leiden, P.O. Box 9600, 2300 RC, Leiden, The Netherlands.
Ad A KapteinDepartment of Medical Psychology, Leiden University Medical Center, P.O. Box 9600, 2300 RC, Leiden, The Netherlands.
Maarten J FischerDepartment of Medical Psychology, Leiden University Medical Center, P.O. Box 9600, 2300 RC, Leiden, The Netherlands.
Elma Meershoek-Klein KranenbargDepartment of Surgery, Leiden University Medical Center, P.O. Box 9600, 2300 RC, Leiden, The Netherlands.
Marjolijn Duijm-de CarpentierDepartment of Surgery, Leiden University Medical Center, P.O. Box 9600, 2300 RC, Leiden, The Netherlands.
Danielle CohenDepartment of Pathology, Leiden University Medical Center, P.O. Box 9600, 2300 RC, Leiden, The Netherlands.
Hiltje de GraafDepartment of Medical Oncology, Medical Center Leeuwarden, P.O. Box 888, 8901 NR, Leeuwarden, The Netherlands.
Joan B HeijnsDepartment of Medical Oncology, Amphia, P.O. Box 90157, 4800 RL, Breda, The Netherlands.
Johanneke E A PortieljeDepartment of Medical Oncology, Leiden University Medical Center, Albinusdreef 2, Leiden, P.O. Box 9600, 2300 RC, Leiden, The Netherlands.
Agnes J van de WouwDepartment of Medical Oncology, Viecuri, 5912 BL, Venlo, The Netherlands.
Alex L T ImholzDepartment of Medical Oncology, Deventer Hospital, P.O. Box 5001, 7416 SE, Deventer, The Netherlands.
Lonneke W KesselsDepartment of Medical Oncology, Deventer Hospital, P.O. Box 5001, 7416 SE, Deventer, The Netherlands.
Suzan VrijaldenhovenDepartment of Medical Oncology, Noordwest Hospital Group, Location Alkmaar, P.O. Box 501, 1815 JD, Alkmaar, The Netherlands.
Arnold BaarsDepartment of Medical Oncology, Hospital Gelderse Vallei, 6710 HN, Ede, The Netherlands.
Marta FioccoDepartment of Medical Statistics and Bioinformatics, Leiden University Medical Center, P.O. Box 9600, 2300RC, Leiden, The Netherlands.
Jacobus J M van der HoevenDepartment of Medical Oncology, Leiden University Medical Center, Albinusdreef 2, Leiden, P.O. Box 9600, 2300 RC, Leiden, The Netherlands.
Hans GelderblomDepartment of Medical Oncology, Leiden University Medical Center, Albinusdreef 2, Leiden, P.O. Box 9600, 2300 RC, Leiden, The Netherlands.
Valter D LongoDepartment of Biological Sciences, Longevity Institute, School of Gerontology, University of Southern California, Los Angeles, CA, 90089, USA.
Hanno PijlDepartment of Endocrinology, Leiden University Medical Center, P.O. Box 9600, 2300 RC, Leiden, The Netherlands.
Judith R KroepDepartment of Medical Oncology, Leiden University Medical Center, Albinusdreef 2, Leiden, P.O. Box 9600, 2300 RC, Leiden, The Netherlands. j.r.kroep@lumc.nl.ORCID http://orcid.org/0000-0003-2671-1903
Dutch Breast Cancer Research Group (BOOG)
Leiden University Medical Center · NLDeventer Ziekenhuis · NLAmphia Ziekenhuis · NLMedisch Centrum Leeuwarden · NLNoordwest Ziekenhuisgroep · NLUniversity of Southern California · USVieCuri Medisch Centrum · NLZiekenhuis Gelderse Vallei · NL

Funding

Amgen Nederland 20139098Pink Ribbon Foundation 2012.WO31.C155
6 · The paper itself

Abstract

purposeIn the phase II DIRECT study a fasting mimicking diet (FMD) improved the clinical response to neoadjuvant chemotherapy as compared to a regular diet. Quality of Life (QoL) and illness perceptions regarding the possible side effects of chemotherapy and the FMD were secondary outcomes of the trial.

methods131 patients with HER2-negative stage II/III breast cancer were recruited, of whom 129 were randomly assigned (1:1) to receive either a fasting mimicking diet (FMD) or their regular diet for 3 days prior to and the day of neoadjuvant chemotherapy. The European Organisation for Research and Treatment of Cancer (EORTC) questionnaires EORTC-QLQ-C30 and EORTC-QLQ-BR23; the Brief Illness Perception Questionnaire (BIPQ) and the Distress Thermometer were used to assess these outcomes at baseline, halfway chemotherapy, before the last cycle of chemotherapy and 6 months after surgery.

resultsOverall QoL and distress scores declined during treatment in both arms and returned to baseline values 6 months after surgery. However, patients' perceptions differed slightly over time. In particular, patients receiving the FMD were less concerned and had better understanding of the possible adverse effects of their treatment in comparison with patients on a regular diet. Per-protocol analyses yielded better emotional, physical, role, cognitive and social functioning scores as well as lower fatigue, nausea and insomnia symptom scores for patients adherent to the FMD in comparison with non-adherent patients and patients on their regular diet.

conclusionsFMD as an adjunct to neoadjuvant chemotherapy appears to improve certain QoL and illness perception domains in patients with HER2-negative breast cancer. Trialregister ClinicalTrials.gov Identifier: NCT02126449.

Indexed as

Breast NeoplasmsQuality of LifeDietFastingFemaleHumansNeoadjuvant TherapyPerceptionSurveys and QuestionnairesBreast cancerChemotherapyDistress thermometerFasting mimicking dietIllness perceptionsQuality of lifeShort-term fasting

Identifiers

PMID33179154
PMCPMC7921018
OpenAlexW3103236395

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

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.