Table 2 Grade III/IV toxicity in both groups (ITT) and in patients who were compliant with the FMD for at least half cycles of CT vs. control patients who did not fast on their own initiative (PP).

From: Fasting mimicking diet as an adjunct to neoadjuvant chemotherapy for breast cancer in the multicentre randomized phase 2 DIRECT trial

Grade III/IV

FMD (N = 65)

FMD-C (N = 22)

FMD-NC (N = 43)

Control (N = 64)

P-value (ITT)

P-value (PP)

Total

31 (47.7%)

11 (50.0%)

20 (46.5%)

36 (56.3%)

0.331

0.539

Neutropenic fever

5 (7.7%)

1 (4.5%)

4 (9.3%)

5 (7.8%)

0.980

0.548

Neutropenia

19 (29.2%)

6 (27.3%)

13 (30.2%)

18 (28.1%)

0.890

0.777

  1. Grade III/IV side effects were scored according CTCAE4.03. Each side effect was scored maximal once per patient during the course. FMD fasting mimicking diet, C compliant, NC not compliant, ITT intention to treat, PP per protocol, CT chemotherapy.
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