Fasting mimicking diet as an adjunct to neoadjuvant chemotherapy for breast cancer in the multicentre randomized phase 2 DIRECT trial

Stefanie Groot, Rieneke T. Lugtenberg, Danielle Cohen, Marij J. P. Welters, Ilina Ehsan, Maaike P. G. Vreeswijk, Vincent T. H. B. M. Smit, Hiltje Graaf, Joan B. Heijns, Johanneke E. A. Portielje, Agnes J. Wouw, Alex L. T. Imholz, Lonneke W. Kessels, Suzan Vrijaldenhoven, Arnold Baars, Elma Meershoek-Klein Kranenbarg, Marjolijn Duijm- de Carpentier, Hein Putter, Jacobus J. M. Hoeven, Johan W. R. Nortier, Valter D. Longo, Hanno Pijl and Judith R. Kroep ()
Additional contact information
Stefanie Groot: Leiden University Medical Center
Rieneke T. Lugtenberg: Leiden University Medical Center
Danielle Cohen: Leiden University Medical Center
Marij J. P. Welters: Leiden University Medical Center
Ilina Ehsan: Leiden University Medical Center
Maaike P. G. Vreeswijk: Leiden University Medical Center
Vincent T. H. B. M. Smit: Leiden University Medical Center
Hiltje Graaf: Medical center Leeuwarden
Joan B. Heijns: Amphia
Johanneke E. A. Portielje: Leiden University Medical Center
Agnes J. Wouw: Viecuri
Alex L. T. Imholz: Deventer hospital
Lonneke W. Kessels: Deventer hospital
Suzan Vrijaldenhoven: Noordwest hospital group, location Alkmaar
Arnold Baars: Hospital Gelderse vallei
Elma Meershoek-Klein Kranenbarg: Leiden University Medical Center
Marjolijn Duijm- de Carpentier: Leiden University Medical Center
Hein Putter: Leiden University Medical Center
Jacobus J. M. Hoeven: Leiden University Medical Center
Johan W. R. Nortier: Leiden University Medical Center
Valter D. Longo: University of Southern California
Hanno Pijl: Leiden University Medical Center
Judith R. Kroep: Leiden University Medical Center

Nature Communications, 2020, vol. 11, issue 1, 1-9

Abstract: Abstract Short-term fasting protects tumor-bearing mice against the toxic effects of chemotherapy while enhancing therapeutic efficacy. We randomized 131 patients with HER2-negative stage II/III breast cancer, without diabetes and a BMI over 18 kg m−2, to receive either a fasting mimicking diet (FMD) or their regular diet for 3 days prior to and during neoadjuvant chemotherapy. Here we show that there was no difference in toxicity between both groups, despite the fact that dexamethasone was omitted in the FMD group. A radiologically complete or partial response occurs more often in patients using the FMD (OR 3.168, P = 0.039). Moreover, per-protocol analysis reveals that the Miller&Payne 4/5 pathological response, indicating 90–100% tumor-cell loss, is more likely to occur in patients using the FMD (OR 4.109, P = 0.016). Also, the FMD significantly curtails chemotherapy-induced DNA damage in T-lymphocytes. These positive findings encourage further exploration of the benefits of fasting/FMD in cancer therapy. Trial number: NCT02126449.

Date: 2020
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DOI: 10.1038/s41467-020-16138-3

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