Property:Results after intervention
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Mantovani et al. (2010): Randomized Phase III Clinical Trial of Five Different Arms of Treatment in 332 Patients with Cancer Cachexia +
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Mantovani et al. (2010): Randomized Phase III Clinical Trial of Five Different Arms of Treatment in 332 Patients with Cancer Cachexia +
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Mantovani et al. (2010): Randomized Phase III Clinical Trial of Five Different Arms of Treatment in 332 Patients with Cancer Cachexia +
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Margalit et al. (2012): Beta-carotene Antioxidant Use During Radiation Therapy and Prostate Cancer Outcome in the Physicians’ Health Study +
'''Overall'''
No significant difference between the intervention and placebo group (p = 0.24), even taking into account the kind of radiotherapy (external beam radiation vs. brachytherapy, p = 0.52) and other control variables (age at treatment, Gleason score, PSA concentration, and clinical stage)
Number of lethal cases in patients receiving prostatectomy with vs. without beta-carotene: 35 vs. 17 (p = 0.03; p = 0.15 when considering control variables) +
Martin et al. (2002): Does prophylactic treatment with proteolytic enzymes reduce acute toxicity of adjuvant pelvic irradiation? Results of a double-blind randomized trial +
There were 29 requirements for supportive medication due to acute toxicities in the enzyme arm and 19 in the placebo arm:
Enzyme arm: 22 for diarrhea; 2 for antibiotics; 1 for analgestics, 0 for antiemetics, 3 for treatment of epitheliolysis; 1 for antidepressiva
Placebo arm: 11 for diarrhea, 1 for antibiotics , 3 for analgestics; 2 for antiemetics , 2 for treatment of epitheliolysis, 0 for antidepressiva +
Martin et al. (2002): Does prophylactic treatment with proteolytic enzymes reduce acute toxicity of adjuvant pelvic irradiation? Results of a double-blind randomized trial +
'''Diarrhea'''
In the enzyme arm 12 (43%) patients developed no or mild and 16 (57%) moderate or severe diarrhea during the entire radiation treatment; in the placebo arm 18 (64%) patients developed no or mild and 10 (36%) moderate or severe diarrhea; mean duration of moderate or severe diarrhea was 11 days in the enzyme arm and 10 days in the placebo arm; the difference was not statistically significant (p= 0.11)
'''Vomiting'''
All 28 patients in the enzyme arm developed no or mild vomiting; in the placebo arm 27 patients developed no or mild and 1 patient moderate or severe vomiting; no significant group differences (p= NI)
Nausea: 26 patients (93%) in each arm developed no or mild and 2 (7%) moderate or severe nausea; no significant group differences (p= NI)
'''Fatigue'''
In the enzyme arm 23 (82%) patients developed no or mild and 5 (18%) moderate or severe fatigue in the entire radiation treatment; in the placebo arm 26 (93%) patients developed no or mild and 2 (7%) moderate or severe fatigue; difference was statistically not significant (p = 0.23); no group differences in the average values (p=NI)
'''Epitheliolyse'''
In the enzyme arm 21 (75%) patients developed no or mild, 7 (25%) patients moderate or severe
epitheliolysis; in the placebo arm 25 (89%) developed no or mild, 3 (11%) moderate or severe epitheliolysis; the difference was statistically not significant (p= 0.16); no group differences in the average values (p=NI) +
Martin et al. (2002): Does prophylactic treatment with proteolytic enzymes reduce acute toxicity of adjuvant pelvic irradiation? Results of a double-blind randomized trial +
Treatment interruptions (mean days) due to acute toxicity were 2.44 days in the enzyme arm and 1.46 days in the placebo arm. 52 out of 56 patients (92.8%) finished the entire radiation treatment as planned; 4 (7.2%) patients finished radiation prematurely (enzyme arm: 2; placebo arm: 2 patients). +
Marucci et al. (2017): Double-blind randomized phase III study comparing a mixture of natural agents versus placebo in the prevention of acute mucositis during chemoradiotherapy for head and neck cancer +
61 patients (58.6%) developed peak grade 3 objective mucositis during treatment, with no difference between arms (p=0.665).
57 patients (54.8%) developed peak grade 3 functional mucositis during treatment with no differences between arms (p=0.442).
67 patients (64.4%) developed peak grade 3 dysphagia during treatment, with no differences between arms (p = 0.132). +
Marucci et al. (2017): Double-blind randomized phase III study comparing a mixture of natural agents versus placebo in the prevention of acute mucositis during chemoradiotherapy for head and neck cancer +
There was no difference in the extent of pain between the groups (p=0.886) +
Marx et al. (2017): The Effect of a Standardized Ginger Extract on Chemotherapy-Induced Nausea-Related Quality of Life in Patients Undergoing Moderately or Highly Emetogenic Chemotherapy: A Double Blind, Randomized, Placebo Controlled Trial +
NA +
Marx et al. (2017): The Effect of a Standardized Ginger Extract on Chemotherapy-Induced Nausea-Related Quality of Life in Patients Undergoing Moderately or Highly Emetogenic Chemotherapy: A Double Blind, Randomized, Placebo Controlled Trial +
NA +
Marx et al. (2017): The Effect of a Standardized Ginger Extract on Chemotherapy-Induced Nausea-Related Quality of Life in Patients Undergoing Moderately or Highly Emetogenic Chemotherapy: A Double Blind, Randomized, Placebo Controlled Trial +
NA +
Marx et al. (2017): The Effect of a Standardized Ginger Extract on Chemotherapy-Induced Nausea-Related Quality of Life in Patients Undergoing Moderately or Highly Emetogenic Chemotherapy: A Double Blind, Randomized, Placebo Controlled Trial +
NA +
Marx et al. (2017): The Effect of a Standardized Ginger Extract on Chemotherapy-Induced Nausea-Related Quality of Life in Patients Undergoing Moderately or Highly Emetogenic Chemotherapy: A Double Blind, Randomized, Placebo Controlled Trial +
NA +
Marx et al. (2017): The Effect of a Standardized Ginger Extract on Chemotherapy-Induced Nausea-Related Quality of Life in Patients Undergoing Moderately or Highly Emetogenic Chemotherapy: A Double Blind, Randomized, Placebo Controlled Trial +
NA +
Marx et al. (2017): The Effect of a Standardized Ginger Extract on Chemotherapy-Induced Nausea-Related Quality of Life in Patients Undergoing Moderately or Highly Emetogenic Chemotherapy: A Double Blind, Randomized, Placebo Controlled Trial +
NA +
Mayne et al. (2001): Randomized Trial of Supplemental beta-Carotene to Prevent Second Head and Neck Cancer +
'''Overall'''
a) Less risk for intervention group but no significant difference between intervention and placebo group regarding hazard ratio
b) Higher risk for intervention group but no significant difference between intervention and placebo group regarding hazard ratio +
Mayne et al. (2001): Randomized Trial of Supplemental beta-Carotene to Prevent Second Head and Neck Cancer +
'''Overall'''
Less risk for intervention group but no significant difference between intervention and placebo group regarding hazard ratio +
Mayne et al. (2001): Randomized Trial of Supplemental beta-Carotene to Prevent Second Head and Neck Cancer +
''Overall OS:'' no significant difference between intervention and placebo group regarding hazard ratio
''a) mean age (SD):'' intervention group 69.7 (6.4) vs. placebo group 64.4 (8.8); p = 0.01
b) both smokers and non-smokers not significantly better in intervention arm
c) no significant difference in hazard ratio for low vs. high plasma beta-carotene +
Mayne et al. (2001): Randomized Trial of Supplemental beta-Carotene to Prevent Second Head and Neck Cancer +
'''Overall'''
- No significant difference between intervention and placebo group regarding hazard ratio and time period until occurrence (p=0.59)
- Less risk for intervention group (not significant) +