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. 2020 Nov 11;185(3):741–758. doi: 10.1007/s10549-020-05991-x

Table 4.

Mean scores of QLQ-C30 and QLQ-BR23 functioning scales and symptom ratings by treatment arm

Questionnaire time points p value
Baseline Halfway CT Before last cycle of CT 6 months after surgery Time Randomization Time by randomization
EORTC-QLQ-C30
 Global Health
  Regular diet 80.5 70.3 59.2 75.8  <0.001 0.298 0.883
  FMD 79.5 71.2 61.5 78.7
Functioning scales
 Physical functioning
  Regular diet 93.7 81.9 68.8 82.8  <0.001 0.316 0.562
  FMD 96.4 84.0 77.0 86.2
 Role functioning
  Regular diet 90.1 66.1 52.4 74.1  <0.001 0.392 0.653
  FMD 86.7 67.0 52.9 78.1
 Emotional functioning
  Regular diet 75.3 80.7 73.4 78.1 0.048 0.215 0.631
  FMD 69.9 80.2 78.4 80.0
 Cognitive functioning
  Regular diet 89.4 77.2 70.5 76.9 0.011 0.106 0.533
  FMD 84.2 80.3 75.5 74.8
 Social functioning
  Regular diet 92.0 74.9 62.8 83.6 0.005 0.467 0.724
  FMD 88.6 78.8 68.6 83.3
Symptoms
 Fatigue
  Regular diet 19.0 39.8 52.8 31.1  <0.001 0.154 0.393
  FMD 23.0 39.3 43.5 28.9
 Nausea
  Regular diet 4.3 15.5 5.9 2.5  <0.001 0.629 0.312
  FMD 4.2 12.1 7.4 3.1
 Pain
  Regular diet 11.5 15.8 22.9 17.3  <0.001 0.992 0.159
  FMD 7.6 8.5 25.5 20.0
 Dyspnea
  Regular diet 4.6 14.0 26.4 16.0 0.001 0.694 0.045
  FMD 3.7 20.6 20.6 9.6
 Insomnia
  Regular diet 26.4 26.9 37.5 38.3  <0.001 0.068 0.246
  FMD 32.7 19.4 39.2 31.1
 Appetite loss
  Regular diet 9.8 17.5 29.9 7.4  <0.001 0.196 0.535
  FMD 14.5 17.0 21.6 5.2
 Constipation
  Regular diet 2.3 25.1 22.2 8.0  <0.001 0.654 0.826
  FMD 2.4 23.0 16.7 8.1
 Diarrhea
  Regular diet 6.9 7.0 10.4 1.2  <0.001 0.623 0.749
  FMD 4.8 7.3 13.7 2.2
 Financial difficulties
  Regular diet 2.9 9.9 11.8 6.2 0.807 0.981 0.014
  FMD 3.8 8.5 5.9 14.1
EORTC-QLQ-BR23
 Body image
  Regular diet 89.9 78.8 65.1 78.4  <0.001 0.466 0.366
  FMD 90.3 73.2 68.4 74.3
 Sexual functioning
  Regular diet 77.0 81.9 86.8 73.0  <0.001 0.815 0.292
  FMD 76.1 78.5 86.3 75.8
 Sexual enjoyment
  Regular diet 58.1 44.4 43.1 55.9 0.001 0.554 0.040
  FMD 56.1 49.5 42.9 48.7
 Future perspective
  Regular diet 42.0 34.5 45.8 40.7 0.184 0.579 0.085
  FMD 47.9 40.1 37.3 38.5
Symptom scales
 Side effects of systemic therapy
  Regular diet 10.5 32.8 40.0 18.5  <0.001 0.378 0.817
  FMD 9.6 31.9 35.9 16.5
 Upset by hair loss
  Regular diet 16.7 32.6 31.1 50.0 0.003 0.465 0.187
  FMD 33.3 36.8 31.4 40.0
 Distress thermometer
  Regular diet 5.21 6.27 6.17 0.468 0.358 0.465
  FMD 5.16 5.53 5.98

P-values < 0.05 were considered significant

P time changes of QoL scores over time, P randomization differences in QoL between the two treatment groups (FMD vs. regular diet), P time by randomization different effects between treatment groups over time, CT chemotherapy, FMD fasting mimicking diet.