Rieneke T Lugtenberg1, Stefanie de Groot1, Ad A Kaptein2, Maarten J Fischer2, Elma Meershoek-Klein Kranenbarg3, Marjolijn Duijm-de Carpentier3, Danielle Cohen4, Hiltje de Graaf5, Joan B Heijns6, Johanneke E A Portielje1,7, Agnes J van de Wouw8, Alex L T Imholz9, Lonneke W Kessels9, Suzan Vrijaldenhoven10, Arnold Baars11, Marta Fiocco12, Jacobus J M van der Hoeven1, Hans Gelderblom1, Valter D Longo13,14, Hanno Pijl15, Judith R Kroep16. 1. Department of Medical Oncology, Leiden University Medical Center, Albinusdreef 2, Leiden, P.O. Box 9600, 2300 RC, Leiden, The Netherlands. 2. Department of Medical Psychology, Leiden University Medical Center, P.O. Box 9600, 2300 RC, Leiden, The Netherlands. 3. Department of Surgery, Leiden University Medical Center, P.O. Box 9600, 2300 RC, Leiden, The Netherlands. 4. Department of Pathology, Leiden University Medical Center, P.O. Box 9600, 2300 RC, Leiden, The Netherlands. 5. Department of Medical Oncology, Medical Center Leeuwarden, P.O. Box 888, 8901 NR, Leeuwarden, The Netherlands. 6. Department of Medical Oncology, Amphia, P.O. Box 90157, 4800 RL, Breda, The Netherlands. 7. Department of Medical Oncology, Haga Hospital, Den Haag, P.O. Box 40551, 2504 LN, The Hague, The Netherlands. 8. Department of Medical Oncology, Viecuri, 5912 BL, Venlo, The Netherlands. 9. Department of Medical Oncology, Deventer Hospital, P.O. Box 5001, 7416 SE, Deventer, The Netherlands. 10. Department of Medical Oncology, Noordwest Hospital Group, Location Alkmaar, P.O. Box 501, 1815 JD, Alkmaar, The Netherlands. 11. Department of Medical Oncology, Hospital Gelderse Vallei, 6710 HN, Ede, The Netherlands. 12. Department of Medical Statistics and Bioinformatics, Leiden University Medical Center, P.O. Box 9600, 2300RC, Leiden, The Netherlands. 13. Department of Biological Sciences, Longevity Institute, School of Gerontology, University of Southern California, Los Angeles, CA, 90089, USA. 14. IFOM FIRC Institute of Molecular Oncology, Via Adamello 16, Milan, Italy. 15. Department of Endocrinology, Leiden University Medical Center, P.O. Box 9600, 2300 RC, Leiden, The Netherlands. 16. Department of Medical Oncology, Leiden University Medical Center, Albinusdreef 2, Leiden, P.O. Box 9600, 2300 RC, Leiden, The Netherlands. j.r.kroep@lumc.nl.
Abstract
PURPOSE: In 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. METHODS:131 patients with HER2-negative stageII/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. RESULTS:Overall 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. CONCLUSIONS: FMD 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.
RCT Entities:
PURPOSE: In 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. METHODS: 131 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. RESULTS: Overall 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. CONCLUSIONS:FMD 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.
Entities:
Keywords:
Breast cancer; Chemotherapy; Distress thermometer; Fasting mimicking diet; Illness perceptions; Quality of life; Short-term fasting
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