Property:Results during intervention
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Fallon et al. (2017) I: Sativex oromucosal spray as adjunctive therapy in advanced cancer patients with chronic pain unalleviated by optimized opioid therapy: two double-blind, randomized, placebo-controlled phase 3 studies +
No differences between arms after 5 weeks (no p-value). +
Fallon et al. (2017) I: Sativex oromucosal spray as adjunctive therapy in advanced cancer patients with chronic pain unalleviated by optimized opioid therapy: two double-blind, randomized, placebo-controlled phase 3 studies +
No significant difference after 5 weeks
* Sativex arm = 7.2% vs. placebo arm = 9.5% (median difference = −1.84%; CI: −6.19%, 1.50%; p=0.274, not significant)
Subgroup analysis with US population
* shows effects for Sativex arm (p=0.03), especially for patients under 65 years of age +
Fallon et al. (2017) II: Sativex oromucosal spray as adjunctive therapy in advanced cancer patients with chronic pain unalleviated by optimized opioid therapy: two double-blind, randomized, placebo-controlled phase 3 studies +
No arm differences after 5 weeks (no p-value). +
Fallon et al. (2017) II: Sativex oromucosal spray as adjunctive therapy in advanced cancer patients with chronic pain unalleviated by optimized opioid therapy: two double-blind, randomized, placebo-controlled phase 3 studies +
Deterioration in both arms after 5 weeks:
* Sativex arm: from 3.2 to 3.7, Placebo arm: 3.1 to 3.6. (treatment effect -0.02; 95% CI: -0.42, 0.38; p = 0.917)
* No differences for individual subgroups (no US patients in this study) +
Fallon et al. (2017) II: Sativex oromucosal spray as adjunctive therapy in advanced cancer patients with chronic pain unalleviated by optimized opioid therapy: two double-blind, randomized, placebo-controlled phase 3 studies +
No arm differences after 5 weeks (no p-value). +
Fallon et al. (2017) II: Sativex oromucosal spray as adjunctive therapy in advanced cancer patients with chronic pain unalleviated by optimized opioid therapy: two double-blind, randomized, placebo-controlled phase 3 studies +
No arm differences after 5 weeks (no p-value). +
Fallon et al. (2017) II: Sativex oromucosal spray as adjunctive therapy in advanced cancer patients with chronic pain unalleviated by optimized opioid therapy: two double-blind, randomized, placebo-controlled phase 3 studies +
No arm differences after 5 weeks (no p-value). +
Fallon et al. (2017) II: Sativex oromucosal spray as adjunctive therapy in advanced cancer patients with chronic pain unalleviated by optimized opioid therapy: two double-blind, randomized, placebo-controlled phase 3 studies +
No arm differences after 5 weeks (no p-value). +
Ferreira et al. (2004): Protective effect of alpha-tocopherol in head and neck cancer radiation-induced mucositis: A double-blind randomized trial +
Median in weeks:
vitamin E: 1 (Range: 0-5) vs. placebo arm: 2 (range: 0-5); p = 0.102, sign. +
Ferreira et al. (2004): Protective effect of alpha-tocopherol in head and neck cancer radiation-induced mucositis: A double-blind randomized trial +
Difference in kg (Mean baseline - mean during radiotherapy):
vitamin E arm: 4.9, placebo arm: 5.5; p = 0.249, ns. +
Ferreira et al. (2004): Protective effect of alpha-tocopherol in head and neck cancer radiation-induced mucositis: A double-blind randomized trial +
Number (%) with acute complications
Vitamin E vs. placebo arm overall: p = 0.216, not sign.
None: vitamin E: 10 (35.7), placebo arm: 9 (34.6)
mild nausea: vitamin E: 12 (42.8), placebo arm: 10 (38.5)
vomiting: vitamin E: 4 (14.3), placebo arm: 5 (19.2)
fever: vitamin E: 4 (14.3), placebo arm: 1 (3.8)
candidiasis: vitamin E: 2 (7.1), placebo arm: 4 (15.4)
bleeding: vitamin E: 2 (7.1), placebo arm: 9 (34.6) +
Ferreira et al. (2004): Protective effect of alpha-tocopherol in head and neck cancer radiation-induced mucositis: A double-blind randomized trial +
NA +
Ferreira et al. (2004): Protective effect of alpha-tocopherol in head and neck cancer radiation-induced mucositis: A double-blind randomized trial +
Assesment weekly:
Number of mucositis events: vitamin E arm significantly fewer than placebo arm (36 (21.6%) vs. 54 (33.5%); RR = 0.643; 95% KI: 0.42,0.98; p = 0.038, sign.
Number of patients with pain/difficulty eating grade 2-3: vitamin E 3 (10.7%) vs. placebo arm 14 (53.8%); p = 0.0001, sign. +
Frankling et al. (2021): ‘Palliative-D’ - Vitamin D Supplementation to Palliative Cancer Patients: A Double Blind, Randomized Placebo-Controlled Multicenter Trial +
No significant difference +
Frankling et al. (2021): ‘Palliative-D’ - Vitamin D Supplementation to Palliative Cancer Patients: A Double Blind, Randomized Placebo-Controlled Multicenter Trial +
Significantly lower degree of fatigue assessed with ESAS in intervention arm compared to the placebo arm after 12 weeks; −1.1 point (p<0.01);
Assessed with EORTC QLQ-C15-PAL no significant differences +
Frankling et al. (2021): ‘Palliative-D’ - Vitamin D Supplementation to Palliative Cancer Patients: A Double Blind, Randomized Placebo-Controlled Multicenter Trial +
No difference in survival time between the two treatment arms at any timepoint, after 4 weeks (p=0.36), 8 weeks (p=0.09) or 12 weeks (p=0.08) +
Frankling et al. (2021): ‘Palliative-D’ - Vitamin D Supplementation to Palliative Cancer Patients: A Double Blind, Randomized Placebo-Controlled Multicenter Trial +
Vitamin D treatment increased mean 25-OHD significantly, from 36 (±11) nmol/L to 81 (±26) nmol/L (p<0.001), while mean 25-OHD in the placebo arm remained stable +
Frankling et al. (2021): ‘Palliative-D’ - Vitamin D Supplementation to Palliative Cancer Patients: A Double Blind, Randomized Placebo-Controlled Multicenter Trial +
No significant difference +
Frankling et al. (2021): ‘Palliative-D’ - Vitamin D Supplementation to Palliative Cancer Patients: A Double Blind, Randomized Placebo-Controlled Multicenter Trial +
ITT analysis: no significant differences;
PP analysis: mean increase in opioid doses in intervention arm was significantly smaller than in placebo arm, beta coefficient −0.56 (95% CI −1.07; −0.05; p=0.03);
Separate non-longitudinal analysis on data after 12 weeks only: significantly lower opioid doses in the vitamin D arm, −7.0 μg /h (p=0.03) +