Property:Results after intervention
This is a property of type Text.
F
Freedland et al. (2020): A Randomized Controlled Trial of a 6-month low carbohydrate intervention on disease progression in men with recurrent prostate cancer: Carbohydrate and Prostate Study 2 (CAPS2) +
No significant arm differences in the mean PSA doubling time (intervention arm 21 months vs. control arm 15 months; p=0.446, not significant)
Post hoc analysis: after adjustment for key demographic variables and PSA levels possibly reduced by weight loss and associated altered hemoconcentration measurement: slowed PSA doubling in intervention arm compared to control arm; however, questionable +
G
Ghoreishi et al. (2007): Effect of vitamin E on chemotherapy-induced mucositis and neutropenia in leukemic patients undergoing bone marrow transplantation +
No sign. differences according to grade (no values given, only graph and p-values): grade 1: p = 0.31, grade 2: p = 0.25, grade: 3: p = 0.93, grade 4: p = 0.32
Mean length: no significant difference seperated by diagnosis (ALL, CML, AML). +
Ghoreishi et al. (2007): Effect of vitamin E on chemotherapy-induced mucositis and neutropenia in leukemic patients undergoing bone marrow transplantation +
No significant difference regarding the absolute duration of neutropenia (p = 1); no significant difference seperated by diagnosis +
Goossens et al. (2016): Phase III randomised chemoprevention study with selenium on the recurrence of non-invasive urothelial carcinoma. The SELEnium and BLAdder cancer Trial +
Remark:
After 3 months: progression in 24 patients, median progression time 22 months in both arms; Patients in intervention arm had 48% more chance of progression than those in the placebo arm, but not statistically significant (HR = 1.48 (95% CI: 0.65, 3.38); p=0.35);
Progression in the intervention arm 15x, placebo arm 14x ITT: HR: 0.97 (95% CI: 0.47, 2.00); p=0.93, not significant +
Goossens et al. (2016): Phase III randomised chemoprevention study with selenium on the recurrence of non-invasive urothelial carcinoma. The SELEnium and BLAdder cancer Trial +
ITT: intervention arm n=43 (28%; 95% CI: 0.21, 0.35) and placebo arm n=45 (32%; 95% CI: 0.24, 0.40); HR: 0.85 (95% CI: 0.56, 1.29); p=0.44, not significant
PP: (all participants remaining in the study after 3 months): intervention arm n=42 and placebo arm n=39 (28%; 95% CI: 0.20, 0.35); HR: 0.96 (95% CI: 0.62, 1.48)); p=0.85, not significant
No influence of age, gender, nicotine consumption, stage, selenium concentration at baseline and hospital +
Goossens et al. (2016): Phase III randomised chemoprevention study with selenium on the recurrence of non-invasive urothelial carcinoma. The SELEnium and BLAdder cancer Trial +
Significant difference in selenium concentration after 3 years (n=67 (55%)): 187.6 mg/dl ± 57.7 mg/dl intervention arm vs. 88.9 mg/dl ± 22.2 mg/dl placebo arm; p=0.00 +
Gorgu et al. (2013): The effect of zinc sulphate in the prevention of radiation induced oral mucositis in patents with head and neck cancer +
NI +
Gorgu et al. (2013): The effect of zinc sulphate in the prevention of radiation induced oral mucositis in patents with head and neck cancer +
NI +
Gorgu et al. (2013): The effect of zinc sulphate in the prevention of radiation induced oral mucositis in patents with head and neck cancer +
NI +
Grimison et al. (2020): Oral THC:CBD cannabis extract for refractory chemotherapy-induced nausea and vomiting: a randomised, placebo-controlled, phase II crossover trial +
NA +
Grimison et al. (2020): Oral THC:CBD cannabis extract for refractory chemotherapy-induced nausea and vomiting: a randomised, placebo-controlled, phase II crossover trial +
NA +
Grimison et al. (2020): Oral THC:CBD cannabis extract for refractory chemotherapy-induced nausea and vomiting: a randomised, placebo-controlled, phase II crossover trial +
NA +
Grimison et al. (2020): Oral THC:CBD cannabis extract for refractory chemotherapy-induced nausea and vomiting: a randomised, placebo-controlled, phase II crossover trial +
NA +
Gujral et al. (2001): Efficacy of hydrolytic enzymes in preventing radiation therapy-induced side effects in patients with head and neck cancers +
Enzyme-arm: no evaluation N=3, complete/good response in N=32/16, moderate response N=1, poor/no response/progress N=1
Control-arm: no evaluation N=4, complete/good response N=23/15, moderate response N=5, poor/no response/progress N=0,
but arm difference is not statistically significant (p=0.23) +
Gujral et al. (2001): Efficacy of hydrolytic enzymes in preventing radiation therapy-induced side effects in patients with head and neck cancers +
In both arms a comparable rate of complete and partial remissions was observed, but the proportion of patients with complete regression was slightly higher in the enzyme-arm. +
Gujral et al. (2001): Efficacy of hydrolytic enzymes in preventing radiation therapy-induced side effects in patients with head and neck cancers +
The maximum extent of acute radiation side effects such as mucositis was significantly lower in the enzyme-arm than in the control-arm (p<0.0001): Enzyme-arm = 1.32(0.64); control-arm =2.24 (0.60). Mucosal reactions were graded about one grade lower and the number of patients with severe mucositis was considerably less:
Numbers of patients per grade:
Enzyme-arm: Grade 0 = 2; Grade 1 = 35; Grade 2 = 13; Grade 3 = 3
Control-arm: Grade 0 = 0; Grade 1 = 4; Grade 2 = 27; Grade 3 = 15 +
Gujral et al. (2001): Efficacy of hydrolytic enzymes in preventing radiation therapy-induced side effects in patients with head and neck cancers +
The same grade of mucositis, skin reactions and dysphagia was reached later in patients from the enzyme-arm, the differences between the arms were statistically significant.
Mucositis grade 2: Enzyme-arm = 6.9(0.8) weeks; control-arm = 5.7(1.2) weeks, p=0.0014
Skin reactions grade 2: Enzyme-arm = 6.6(1.6) weeks; control-arm = 5.7(1.4) weeks, p=0.0048
Dysphagia Grade 1/2: Enzyme-arm = 5.2/7.3(1.5/0.8) weeks; control-arm = 3.6/6.1(0.5/1.3), p=0.0092/0.0064 +
Gujral et al. (2001): Efficacy of hydrolytic enzymes in preventing radiation therapy-induced side effects in patients with head and neck cancers +
In none of the patients of the enzyme-arm were skin reactions of grade 4. The difference between the two arms was statistically significant (p<0.0001): Enzyme-arm: 1.23(0.75); control-arm: 2.39(1.10)
Numbers of patients per grade:
Enzyme-arm: Grade 1 = 8; Grade 2 = 27; Grade 3 = 16; Grade 4 = 2
Control-arm: Grade 1 = 0; Grade 2 = 11; Grade 3 = 17; Grade 4 = 11 +
Gujral et al. (2001): Efficacy of hydrolytic enzymes in preventing radiation therapy-induced side effects in patients with head and neck cancers +
The average score for mucositis, skin reactions and dysphagia was lower in the enzyme-arm than in the control-arm, the differences between the arms are statistically significant.
Mucositis: Enzyme-arm = 5.4(3.6); control-arm = 10.2(3.6), p=0.0001
Skin reactions: Enzyme-arm = 3.9(2.9); control-arm = 9.5(3.9), p=0.0001
Dysphagia: Enzyme-arm = 5.2(3.4); control-arm = 10.1(3.6), p=0.0001 +
Gujral et al. (2001): Efficacy of hydrolytic enzymes in preventing radiation therapy-induced side effects in patients with head and neck cancers +
The difference between the arms was statistically significant (p<0.0001): Enzyme-arm: 1.33(0.63); Control-arm:2.24 (0.60). The number of patients with severe problems in swallowing was considerably less.
Numbers of patients per grade:
Enzyme-arm: Grade 0 = 0; Grade 1 = 37; Grade 2 = 12; Grade 3 = 4; Grade 4 = 0
Control-arm: Grade 0 = 0; Grade 1 = 5; Grade 2 = 29; Grade 3 = 12; Grade 4 = 0 +