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.TrialregisterClinicalTrials.gov Identifier: NCT02126449.
Highlights
Short-term fasting (STF) during cancer treatment has attracted increasing attention since the first report of benefits in mice in 2008 [1]
We recently reported that an fasting mimicking diet (FMD), as compared to regular diet, enhanced the radiological as well as the pathological tumor response to chemotherapy in women with HER2-negative breast cancer [8]
Fifty three out of 65 patients (81.5%) completed the first FMD cycle, whereas over 50% completed at least 2 FMD cycles. 22 out of 65 patients (33.8%) used the FMD for at least four cycles, and 21.5% of the patients adhered to FMD during all cycles of chemotherapy (Table 2)
Summary
Short-term fasting (STF) during cancer treatment has attracted increasing attention since the first report of benefits in mice in 2008 [1]. In rodents, fasting limits tumor proliferation and enhances the sensitivity of tumor cells to cancer therapies, while simultaneously protecting healthy cells against its toxic effects [2,3,4]. These experimental benefits triggered a number of small clinical trials exploring. Fasting mimicking diets (FMD) are designed to mimic the physiologic effects of water-only fasting, while offering minimally required (micro)nutrients [4, 7]. Despite omitting dexamethasone prior to chemotherapy in the FMD arm, grade III/IV toxicity was similar in both study arms and chemotherapy-induced DNA damage in lymphocytes was less in patients receiving the FMD, suggesting that the diet simultaneously limits adverse effects in healthy cells
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