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
A secondary analysis of quality of life and illness perceptions in the phase 2 DIRECT trial.
Breast Cancer Res Treat, 2021. Lugtenberg RT, et al.
Funding and competing interests (as published with the paper): 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.
- Study type
- Human clinical trial (randomized, phase 2, secondary outcomes, n=131)
- Journal
- Breast Cancer Res Treat
- Published
- 2021
- Authors
- Lugtenberg RT, et al.
- DOI
- 10.1007/s10549-020-05991-x
- PubMed ID
- 33179154
Summary
Quality of life and illness perceptions were secondary outcomes of the phase 2 DIRECT trial. One hundred and thirty-one patients with HER2-negative stage II or III breast cancer were recruited, of whom 129 were randomly assigned to receive either a Fasting Mimicking Diet (FMD) or their regular diet for three days before and on the day of neoadjuvant chemotherapy. Participants completed the EORTC QLQ-C30 and QLQ-BR23 questionnaires, the Brief Illness Perception Questionnaire and the Distress Thermometer at baseline, halfway through chemotherapy, before the last cycle, and six months after surgery.
The authors reported that overall quality of life and distress scores declined during treatment in both arms and returned to baseline values six months after surgery. They reported that patients receiving the diet were less concerned about the possible adverse effects of their treatment and understood them better than patients on a regular diet. They reported that per-protocol analyses yielded better emotional, physical, role, cognitive and social functioning scores, and lower fatigue, nausea and insomnia symptom scores, for patients who adhered to the diet, compared with patients who did not adhere and patients on their regular diet. They describe the diet as appearing to improve certain quality of life and illness perception domains.
These are secondary outcomes, measured with self-reported questionnaires. The functioning and symptom findings come from a per-protocol comparison of patients who adhered to the diet, which is no longer a randomized comparison and can reflect differences between people who adhere and people who do not. The overall quality of life measure followed the same course in both arms. Participants were breast cancer patients receiving neoadjuvant chemotherapy, not a general wellness population, and the study does not evaluate Prolon directly.
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