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Property:Results after intervention

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Overall number (%): Diarrhea: intervention arm: 10 (55.6) (grade 1: n = 5, grade 2: n = 5); placebo arm: 4 (18.8) (grade 1: n = 3, grade 3: n = 1); p = 0.06; No differences with regard to nausea (p = 0.36), vomiting (p = 0.38), mucositis (p = 0.38), fatigue (p = 0.20), headache (p = 0.45), dizziness (p = 0.54), bleeding (p = 0.90)  +
Vomiting (all three cycles): no significant between arms Among participants with the Chemotherapy regimen AC (doxorubicin+cyclophosphamide) in intervention arm significantly lower severity of vomiting than in placebo arm, mean (SD): 0.64 (0.87) vs. 1.13 (1.12), p<0.05  +
Number with CIPN ITT: intervention arm: 5/16 (31.25%); control arm: 13/19 (68.4%); p = 0.03 PP: intervention arm: 3/14 (21.4%, mild: n = 1, moderate: n = 2); control arm: 11/16 (68.5%, mild: n = 4, moderate: n = 4, severe: n = 3); p = 0.026; RR = 2.51 (95% CI: 1.16,5.47) CIPN score. Mean (SD): ITT: not reported PP: intervention arm: 4.99 (1.33); control arm: 10.47 (10.62); p = 0.023 Neurolog. Data (number of patients) intervention arm: mainly numbness/paresthesia limited to fingers/toes ( n = 1), stocking-and-glove distribution (n = 2), ankle hyporelexia (n = 2) control arm: mainly numbness/paresthesia limited to fingers/toes (n = 4), or extended to knees/elbows (n = 3), stocking-and-glove distribution ( n = 4) Neurophysiolog. Data In each case sign. difference in amplitude sensor. Action potential: N. ulnaris (p = 0.021), peroneus superficialis (p = 0.017); suralis (p = 0.046) Otherwise no sign. Differences  +
Number of patients: ITT: not reported PP: intervention arm: grade 0: 13/14; grade 1: 1/14; control arm: grade 0: 8/16; grade 1: 5/16, grade 2: 2/16; grade 4: 1/16  +
Number with PIPN ITT: intervention arm: 5/18 (27.8%); control arm: 13/19 (68.4%); p = 0.032 PP: intervention arm: 3/16 (18.7%); 10/16 (62.5%); p = 0.03; RR = 0.3 (95% CI: 0.1, 0.9) PIPN score. Mean (SD): ITT: not reported PP: intervention arm: 2.25 (5.1) (range: 0-15), control arm: 11 (11.63; range: 0-32); p = 0.01 Neurolog. Data (number of patients) intervention arm: mainly numbness/paresthesia limited to fingers/toes (n = 1), stocking-and-glove distribution (n = 2), ankle hyporeflexia ( n = 2) control arm: mainly numbness/paresthesia limited to fingers/toes (n = 3), or extended to knees/elbows ( n = 3), stocking-and-glove distribution (n = 4) Neurophysiolog. Data In each case sign. Difference in amplitude sensor. Action potential: N. ulnaris (p = 0.014), peroneus superfic. (p = 0.003); sural nerve (p = 0.008) Otherwise no sign. differences  +
Number of patients ITT: not reported PP: intervention arm: A: grade 0: 13/16; grade 1: 2/16, grade 2: 1/16; control arm: grade 0: 6/16; grade 1: 5/16, grade 2: 4/16; grade 4: 1/16  +
''Acute and delayed nausea'' Severity lower in intervention arm than in control arm, VAS mean (SD) for intervention vs. coontrol: - acute: 1.6 (1.1) vs. 3.9 (1.6), p<0.001 - delayed: 3.6 (1.8) vs. 6.1 (1.7), p<0.001  +