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, Agnes J van de Wouw, Alex L T Imholz, Lonneke W Kessels, Suzan Vrijaldenhoven, Arnold Baars, Marta Fiocco, Jacobus J M van der Hoeven, Hans Gelderblom, Valter D Longo, Hanno Pijl, Judith R Kroep, Dutch Breast Cancer Research Group (BOOG), 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, Agnes J van de Wouw, Alex L T Imholz, Lonneke W Kessels, Suzan Vrijaldenhoven, Arnold Baars, Marta Fiocco, Jacobus J M van der Hoeven, Hans Gelderblom, Valter D Longo, Hanno Pijl, Judith R Kroep, Dutch Breast Cancer Research Group (BOOG)

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 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.

Keywords: Breast cancer; Chemotherapy; Distress thermometer; Fasting mimicking diet; Illness perceptions; Quality of life; Short-term fasting.

Conflict of interest statement

V.D. Longo has equity interest in L-Nutra. H. Pijl has shares in a company that invested in L-Nutra. No conflicts of interest were disclosed by the other authors.

Figures

Fig. 1
Fig. 1
Flow diagram. FMD fasting mimicking diet, ITT intention-to-treat, PP per-protocol
Fig. 2
Fig. 2
a–o Mean changes from baseline on functional and symptom scales of the EORTC-QLQ-C30. These plots show mean changes and 95% CIs calculated from the raw data; they are not model estimates, and they are not adjusted for any covariates. CT chemotherapy, FMD fasting mimicking diet, CI confidence interval. Lower scores on the functional scales (a–f) implicates lower quality of life, lower scores on the symptom scales (g–o) implicate better quality of life
Fig. 2
Fig. 2
a–o Mean changes from baseline on functional and symptom scales of the EORTC-QLQ-C30. These plots show mean changes and 95% CIs calculated from the raw data; they are not model estimates, and they are not adjusted for any covariates. CT chemotherapy, FMD fasting mimicking diet, CI confidence interval. Lower scores on the functional scales (a–f) implicates lower quality of life, lower scores on the symptom scales (g–o) implicate better quality of life
Fig. 2
Fig. 2
a–o Mean changes from baseline on functional and symptom scales of the EORTC-QLQ-C30. These plots show mean changes and 95% CIs calculated from the raw data; they are not model estimates, and they are not adjusted for any covariates. CT chemotherapy, FMD fasting mimicking diet, CI confidence interval. Lower scores on the functional scales (a–f) implicates lower quality of life, lower scores on the symptom scales (g–o) implicate better quality of life
Fig. 3
Fig. 3
a–f Mean scores on functional and symptom scales of the EORTC-QLQ-BR23. These plots show mean scores and 95% CIs calculated from the raw data; they are not model estimates, and they are not adjusted for any covariates. Lower scores on the functional scales (a–d) implicates lower quality of life, lower scores on the symptom scales (e, f) implicate better quality of life. CT chemotherapy, FMD fasting mimicking diet, CI confidence interval
Fig. 4
Fig. 4
Distress thermometer. Psychosocial distress given for 3 time points: halfway therapy, at the end of therapy and at six months follow-up. Error bars indicate the 95% CI. CT chemotherapy, FMD fasting mimicking diet, CI confidence interval
Fig. 5
Fig. 5
a–h Illness perceptions
Fig. 5
Fig. 5
a–h Illness perceptions

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