Property:Side Effects / Interactions
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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 +
Overall 64% at least one event; assessed as probably intervention-associated with frequency ≥ 5%: Total n=41 (20.7%), of which somnolence n=6 (3%), dizziness n=6 (3%), nausea n=8 (4%)
2 severe side effects associated with intervention: 1x constipation (with 360mg/day morphine equivalents), 1x moderate disorientation and somnolence on day 4 (with 2.5 daily sprays of Sativex)
None of the deaths related to intervention +
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 +
''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 62% at least one event; assessed as probably intervention-associated with frequency ≥ 5%: Total n=12, 11.7%; somnolence n=0 +
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 +
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%)
More than twice as many patients in Sativex arm discontinued study due to side effects (n=14, 13.6% vs. n=6, 5.8%); no statistical comparison given)
None of the deaths related to intervention +
Ferreira et al. (2004): Protective effect of alpha-tocopherol in head and neck cancer radiation-induced mucositis: A double-blind randomized trial +
NI +
Ferreira et al. (2004): Protective effect of alpha-tocopherol in head and neck cancer radiation-induced mucositis: A double-blind randomized trial +
NI +
Frankling et al. (2021): ‘Palliative-D’ - Vitamin D Supplementation to Palliative Cancer Patients: A Double Blind, Randomized Placebo-Controlled Multicenter Trial +
n=2 mild hypercalcemia, n=2 gastrointestinal symptoms (mild diarrhea, nausea and abdominal pain), n=1 elevated creatine level +
Frankling et al. (2021): ‘Palliative-D’ - Vitamin D Supplementation to Palliative Cancer Patients: A Double Blind, Randomized Placebo-Controlled Multicenter Trial +
n=1 renal failure, n=2 mild hypercalcemia, n=1 gastrointestinal symptoms (mild diarrhea, nausea and abdominal pain), n=1 shortness of breath +
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) +
Moderate nausea; diarrhea, constipation, headache, fatigue, feeling of weakness (asthenia) +
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) +
Weight loss; moderate nausea; diarrhea, constipation, headache, fatigue, feeling of weakness (asthenia) +
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Ghoreishi et al. (2007): Effect of vitamin E on chemotherapy-induced mucositis and neutropenia in leukemic patients undergoing bone marrow transplantation +
NI +
Ghoreishi et al. (2007): Effect of vitamin E on chemotherapy-induced mucositis and neutropenia in leukemic patients undergoing bone marrow transplantation +
NI +
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 +
Not separated between arms:
Unclear cause: n=13 cystectomy (intervention arm: n=6, placebo arm: n=7), n=23 deceased (intervention arm: n=13, placebo arm: n=10);
Report of side effects: intervention arm: n=7 and placebo arm: n=10, all grade 1 except n=1, grade 2 pain in the intervention arm; side effects were change in nails, back and neck pain, constipation, sleep disturbances, dizziness, and arthralgia, with one n=1 patient reporting nausea, pain, and stomach problems and another patient dizziness and diarrhea +
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 +
Not separated between arms:
Unclear cause: n=13 cystectomy (intervention arm: n=6, placebo arm: n=7), n=23 deceased (intervention arm: n=13, placebo arm: n=10);
Report of side effects: intervention arm: n=7 and placebo arm: n=10, all grade 1 except n=1, grade 2 pain in the intervention arm; side effects were change in nails, back and neck pain, constipation, sleep disturbances, dizziness, and arthralgia, with one n=1 patient reporting nausea, pain, and stomach problems and another patient dizziness and diarrhea +
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 +
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 +
Moderate or severe cannabinoid-related side effects in intervention arm and placebo arm (31% vs. 7%, p=0.002):
* Significant differences for sedation (19% vs. 4%, p=0.002) and dizziness (10% vs. 1%, p=0.03)
* No differences for disorientation (p=0.5) and anxiety (p=1.00)
* No cannabinoid-related serious adverse events reported
83% of the participants preferred cannabis over placebo and 15% had a preference for placebo (p<0.001) +
Grimison et al. (2020): Oral THC:CBD cannabis extract for refractory chemotherapy-induced nausea and vomiting: a randomised, placebo-controlled, phase II crossover trial +
Moderate or severe cannabinoid-related side effects in intervention arm and placebo arm (31% vs. 7%, p=0.002):
* Significant differences for sedation (19% vs. 4%, p=0.002) and dizziness (10% vs. 1%, p=0.03)
* No differences for disorientation (p=0.5) and anxiety (p=1.00)
* No cannabinoid-related serious adverse events reported
83% of the participants preferred cannabis over placebo and 15% had a preference for placebo (p<0.001) +
Gujral et al. (2001): Efficacy of hydrolytic enzymes in preventing radiation therapy-induced side effects in patients with head and neck cancers +
Pain, fever, weakness, vomiting, itching, swelling, haemoptysis; no difference between the arms (p=kA)
Radiation therapy gaps:
9 patients from the Enzyme-arm because of social/technical problems +
Gujral et al. (2001): Efficacy of hydrolytic enzymes in preventing radiation therapy-induced side effects in patients with head and neck cancers +
Pain, fever, weakness, vomiting, itching, swelling, haemoptysis; no difference between the arms (p=kA)
Radiation therapy gaps:
3 gaps because of social/technical problems; in 2 patients in the control-arm, radiation had to be temporarily discontinued due to severe radiation therapy-related reactions +
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