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Property:Results after intervention

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After 5 years: selenium arms not significantly different to placebo arm (p=0.32 and p=0.61) or to each other Subgroup of high-selenium arm with high selenium value at baseline shows higher PSA values than placebo arm (p=0.018)  +
At 12 weeks: Full analysis set: no difference between arms PP analysis: less fatigue/improvement of symptoms in intervention compared to placebo arm (intervention: 41.1%, placebo: 25%; χ² = 5.936; p = 0.015); Overall p = 0.0135  +
Full analysis set: Significant differences between arms at all time points with more improvement in intervention arm: 12 weeks (4 weeks after intervention): Intervention: 57.8%, Placebo: 39.7%; χ² = 7.406; p = 0.007 But no difference of ≥1 grade between arms. As well as an overall significantly steeper improvement in intervention arm (p < 0.05) compared to placebo arm  +
At 12 weeks: In full analysis set and PP-analysis significant change from baseline (p < 0.01, no further data shown).  +
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The comparison of quality of life for the two arms showed that the enzyme arm scored better than the control arm in all items: Items in enzyme arm; control arm: Food: 5.76(2.78); 7.96(2.18) p=0.0004 Language: 1.17(0.63); 2.57(0.93) p<0.0001 Feeling: 0.83(0.36); 1.44(0.76) p<0.0001 Swelling: 3.28(1.57); 4.76(2.06) p=0.0010 Pain: 4.16(2.01); 6.23(1.01) p<0.0001 Nausea: 0.21(0.12); 0.91(0.21) p<0.0001 Daily living: 1.38(0.34); 3.38(0.54) p<0.0001  +
The enzyme arm exhibited significantly lower scores at each time point compared to the control arm (p=0.013-0.044)  +
The enzyme arm exhibited significantly lower swelling than the control arm at each time point (p<0.0001).  +
No study-treatment-related adverse events were observed; No significant difference in the incidence of adverse events between subjects receiving ginger and placebo. Side effects - Intervention in n: Fever: n = 4, Fatigue: n = 25, Muscosites: n = 5, Diarrhea: n = 2, Constipation: n = 14, Neutropenia: n = 6, Thrombcytopenia: n = 14 Side effects - Placebo in n: Fever: n = 3, Fatigue: n = 21, Mucositis: n = 4, Constipation: n = 12, Neutropenia: n = 4, Thrombcytopenia: n = 12, Febrile neutropenia: n = 1 no significant differences  +