Example Queries III
What helps against mucositis in cancer? (just selenium)
| Outcome topic | Results during intervention | Results after intervention | Overall RoB judgment | |
|---|---|---|---|---|
| Jahangard-Rafsanjani et al. (2013): The efficacy of selenium in prevention of oral mucositis in patients undergoing hematopoietic SCT: a randomized clinical trial | Selenium | Onset of mucositis after transplantation comparable in both selenium and placebo arm; p=0.81 | Overall: Cumulative incidence (grade 1-4) comparable in both selenium arm (83.8%) and placebo arm (81.1%); p=0.76; grade 3-4 mucositis significantly lower in selenium arm (10.8%) compared to placebo arm (35.1%); p=0.013 (grade 4: 2x in placebo arm, 0x in selenium arm)
| high risk |
| Laali et al. (2020): Effect of Selenium on Incidence and Severity of Mucositis during Radiotherapy in Patients with Head and Neck Cancer | Selenium | Significant difference for incidence of severe mucositis at week 3: selenium arm 9.8% vs. placebo arm 42.0% (p=0.017) | After 7 weeks no significant differences between the selenium arm and the placebo arm for:
| high risk |
| Mansourian et al. (2015): The effect of "curcuma Longa" topical gel on radiation -induced oral mucositis in patients with head and neck cancer | Curcumin | Significant difference between intervention vs. placebo arm in mean (SD): intervention 3.7 (2.1) vs. placebo 7.9 (2.0); p < 0.001 | NA | some concerns |
| Mansourian et al. (2015): The effect of "curcuma Longa" topical gel on radiation -induced oral mucositis in patients with head and neck cancer | Curcumin | Max. degree of mucositis (number (%) of patients):
| NA | some concerns |
| Mix et al. (2015): Randomized phase II trial of selenomethionine as a modulator of efficacy and toxicity of chemoradiation in squamous cell carcinoma of the head and neck | Selenium | NA | Overall: No significant differences between arms (grade 3 intervention arm 2x, placebo arm 3x, no grade 4) | some concerns |
| ... further results | ||||
What are side effects of cannabis? (arm-based!)
| Intervention | Side Effects / Interactions | |
|---|---|---|
| Côté et al. (2016): Improving Quality of Life With Nabilone During Radiotherapy Treatments for Head and Neck Cancers: A Randomized Double-Blind Placebo-Controlled Trial | Nabilon
| No differences for sleepiness (p=0.32), anxiety (p=0.92) and xerostomia (p=0.83) No differences for sleepiness (p=0.32), anxiety (p=0.92) and xerostomia (p=0.83) |
| 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 | Sativex Placebo | Overall 68% at least one event; assessed as probably intervention-associated with frequency ≥ 5%:
Total n=64 (32.2%), of which somnolence n=18 (9%), dizziness n=15 (7.5%), nausea n=10 (5%)
|
| 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 | Sativex Placebo | Part A
Overall 60% at least one event, assessed as probably intervention-associated with frequency ≥ 5%: Total n=128, 31.7%, somnolence (n=42, 10.4%), nausea (n=21, 5.2%) and dizziness (n=21, 5.2%) Part B Overall 72% at least one event; assessed as probably intervention-associated with frequency ≥ 5%: Total n=16, 15.5%; somnolence (n=6, 5.8%)
None of the deaths related to intervention Overall 60% at least one event, assessed as probably intervention-associated with frequency ≥ 5%: Total n=128, 31.7%, somnolence (n=42, 10.4%), nausea (n=21, 5.2%) and dizziness (n=21, 5.2%)
|
| Grimison et al. (2020): Oral THC:CBD cannabis extract for refractory chemotherapy-induced nausea and vomiting: a randomised, placebo-controlled, phase II crossover trial | THC:CBD Placebo | Moderate or severe cannabinoid-related side effects in intervention arm and placebo arm (31% vs. 7%, p=0.002):
|
| Jatoi et al. (2002): Dronabinol Versus Megestrol Acetate Versus Combination Therapy for Cancer-Associated Anorexia: A North Central Cancer Treatment Group Study | Megestrol Acetate Dronabinol Megestrol Acetate + Dronabinol | Impotence in 18 % of men; vomiting; fluid retention; confused thinking; drowsiness; loss of coordination; inappropriate behavior Impotence in 4% of men; vomiting; fluid retention; confused thinking; drowsiness; loss of coordination; inappropriate behavior Impotence in 14% of men; vomiting; fluid retention; confused thinking; drowsiness; loss of coordination; inappropriate behavior |
| ... further results | ||