Jump to content

Property:Results after intervention

From CAMIH

This is a property of type Text.

Showing 20 pages using this property.
U
V
'''Overall''' - No significant difference for number of SPTs between (vit. A group and vit. A+NAC group) vs. (NAC group and control group) controlled for NAC: p=0.173 - No significant difference for number of tobacco-associated SPTs between (vit. A group and vit. A+NAC group) vs. (NAC group and control group) controlled for NAC: p=0.978 - Interaction with NAC: p = 0.039 i.e. difference between vit. A vs. no vit. A in terms of time period differed depending on whether NAC was additionally given or not - When comparing all four arms, number of SPT in arm D lowest: SPT in general p = 0.025, tobacco-associated SPT p = 0.174  +
'''Overall''' No significant difference for number of first events (recurrence/SPT/death) within 5 years between (vit. A group and vit. A+NAC group) vs. (NAC group and control group): p=0.672  +
'''Overall''' No significant difference for number of deaths within 5 years between (vit. A group and vit. A+NAC group) vs. (NAC group and control group): p=0.925 Interaction (for NAC) not significant, i.e. no influence of NAC on results  +
Mean (SD) for maximum severity of mucositis per arm: Enzyme arm = 1.9 (0.56) Control arm = 2.5 (0.59) The mucositis was less severe in the enzyme arm. The difference is statistically significant (p=0.014). Significantly more patients in the control arm were in stage III (p=0.019).  +
In the enzyme arm mucositis occurred in 17 patients (89.5%) in a period of 5 to 12 days (stage I or II) and in 2 patients (10.5%) between the 19th and 21st day of irradiation (stage III). The mucositis developed on average 9.1 (4.9) days after the start of radiotherapy. In the control arm mucositis occurred over a period of 6 to 21 days after the start of radiotherapy with grade III occurring relatively early from the 12th day after the start of radiotherapy. The mucositis developed on average 13.0 (4.1) days after the start of radiotherapy.  +
After 6 months: Intervention n=42, Placebo n=34, >8 cycles): Placebo had 70.6% and Intervention had 64.3% chemotherapy-induced peripheral neuropathy (not significant, p = 0.56) Secondary analysis showed lower chemotherapy-induced peripheral neuropathy in men in Intervention-arm compared to Placebo-Arm based on 39 patients (p = 0.047, adjusted for age, comorbidity, cycles). Intervention-arm was able to complete more cycles of chemotherapy than Placebo-arm (>8 cycles: 71.7% vs. 56.7%, p = 0.03). No difference in the severity of hematologic toxicity (p = 0.09); due to low overall toxicity, no further analyses were conducted.  +
W
Enzyme-arm: 68% improvement compared to control-arm: 57.69% improvement  +
Treatment discontinuations: There were 2 treatment discontinuations in the enzyme-arm and 9 treatment discontinuations in the control-arm due to more severe side effects such as leukocyte fall, apthae of the oral mucosa or increase in the BUN value. Patients with a survival time of more than 6 months are considered here (16 subjects): Enzyme-arm: 8 patients with an average of 11 infusions and a mean survival time of 20 months Control-arm: 8 patients with an average of 3.37 infusions and a mean survival time of 16.3 months; Distribution across all patients in both arms: Enzyme-arm = 6.88 infusions; Control-arm = 4.50 infusions  +
In patients with survival > 6 months, more patients with better quality of life in enzyme-arm (n=8) compared to control-arm (n=8): (Class I, II enzyme-arm: 81.9% vs. control-arm: 73.3%); similar quality of life in patients with < 6 months survival  +
No sig. differences between the arms (reflexology arm/control arm: 0.387 [2.194]; p= 0.86, reflexology arm/control arm: NI)  +
No sig. differences between the arms (reflexology arm/control arm: ß= -0.487 [1.21]; p=0.69; reflexology arm/foot massage arm: NI)  +