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.
Level 2 - randomized trial
Individual randomized controlled trial
PubMed 33179154 · doi:10.1007/s10549-020-05991-x
What was done
In the phase 2 DIRECT trial, 129 patients with HER2-negative stage II/III breast cancer (out of 131 recruited) were randomized 1:1 to follow either a fasting mimicking diet (FMD) or a regular diet for 3 days before and the day of neoadjuvant chemotherapy. Secondary outcomes included quality of life, illness perceptions, and distress assessed using EORTC-QLQ-C30, EORTC-QLQ-BR23, Brief Illness Perception Questionnaire (BIPQ), and the Distress Thermometer at baseline, mid-chemotherapy, before the final chemotherapy cycle, and 6 months post-surgery.
What was found
The abstract reports no exact numerical values, effect sizes, or p-values. Overall quality of life and distress scores declined during chemotherapy across both study arms and recovered to baseline at 6 months after surgery. Patients randomized to the FMD reported less concern and greater understanding of treatment-related side effects compared to the control group. In per-protocol analyses, patients adherent to the FMD had better emotional, physical, role, cognitive, and social functioning, alongside reduced fatigue, nausea, and insomnia compared to non-adherent patients and those consuming a regular diet.
Why it matters
Adjunctive dietary fasting may ease specific treatment-related symptoms and improve illness perceptions in breast cancer patients undergoing neoadjuvant chemotherapy, though adherence appears critical for observing quality-of-life benefits.
Limits
The abstract provides no point estimates, confidence intervals, or p-values. Key functional and symptom improvements were demonstrated only in per-protocol comparisons rather than the intention-to-treat population, introducing potential compliance and attrition biases. The sample is restricted to HER2-negative stage II/III breast cancer.
Cited by
- supports In clinical trials testing fasting-mimicking diets alongside cancer treatment, subject compliance was approximately 40% due in part to chemotherapy-induced food aversion.