Jump to content

Example Queries II

From CAMIH
Revision as of 13:11, 21 November 2024 by Cotto (talk | contribs)

What effects of selenium have been investigated?

 Outcome name
Asfour et al. (2006): Effect of high-dose sodium selenite therapy on polymorphonuclear leukocyte apoptosis in non-Hodgkin's lymphoma patientsToxicity
Ejection fraction
Büntzel et al. (2010): Limited effects of selenium in the prevention of radiation-associated toxicities - results of a randomized study in head neck cancer patientsToxicity
Büntzel et al. (2010): Selenium Substitution During Radiotherapy of Solid Tumours - Laboratory Data from Two Observation Studies in Gynaecological and Head and Neck Cancer PatientsSelenium level
Goossens et al. (2016): Phase III randomised chemoprevention study with selenium on the recurrence of non-invasive urothelial carcinoma. The SELEnium and BLAdder cancer TrialRFS (Recurrence-Free Survival)
PFS (Progression-Free Survival)
Selenium level
Jahangard-Rafsanjani et al. (2013): The efficacy of selenium in prevention of oral mucositis in patients undergoing hematopoietic SCT: a randomized clinical trialHaematological indices
Length of hospital stay
Incidence of acute GVHD (Graft-Versus-Host Disease)
Mortality rate
Non-haematological indices
Selenium level
Mucositis
Fever
... further results

How does selenium influence survival in cancer?

 Results after interventionOverall RoB judgmentOutcome name
Goossens et al. (2016): Phase III randomised chemoprevention study with selenium on the recurrence of non-invasive urothelial carcinoma. The SELEnium and BLAdder cancer TrialITT: 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
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
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		some concerns
some concerns
some concerns		RFS (Recurrence-Free Survival)
PFS (Progression-Free Survival)
Selenium level
Karp et al. (2012): Randomized, double-blind, placebo-controlled, phase III chemoprevention trial of selenium supplementation in patients with resected stage I non-small-cell lung cancer: ECOG 5597Intervention arm: 76.8% (SE, 1.6%) vs. placebo arm: 79.9% (SE, 2.1%); p=0.154


Note: Distribution significantly different for smoking status (p=0.027): active smokers or those who had quit within one year showed a 3-year OS of 85.5% (SE, 1.7%) and 5-year OS of 74.9% (SE, 2.4%), whereas participants who had never smoked showed a 3-year OS of 90% (SE, 2.8%) and a 5-year OS of 83.6% (SE, 3.6%); no difference for DFS; p=0.245
Collected in 865 patients in intervention arm and 477 in placebo arm:

  • Grade 1-2 toxicity in intervention arm: 31% and placebo arm: 26% of subjects
  • Grade ≥ 3 toxicity occurred in less than 2% of subjects in intervention arm and 3% in placebo arm
  • n=1 patient in placebo arm had constitutional lethal toxicity
  • no arm comparison performed
    Selenium level at baseline (n=1,022), year 2 (n=375), and year 4 (n=194): at baseline selenium level mostly in normal range, after 2 and 4 years significantly increased selenium concentration in the intervention arm
    Interim analysis October 2009:

N=83 secondary lung tumors; Rate intervention arm: 1.91 per 100 persons per year vs. 1.36 in placebo arm; p=ns


June 2011: N=252 secondary tumors in 224 patients, of which 98 (out of 97 patients) were lung cancer (38.9%); Lung cancer and other cancers (SPT) in intervention arm: 1.62 and 3.54 per 100 persons per year vs. placebo arm: 1.30 and 3.39 per 100 persons per year; p=0.294


5-year DFS: October 2009: Intervention arm: 72% vs. placebo arm: 78%, no significance values given


June 2011: Intervention arm: 74.4% vs. placebo arm: 79.6%; p=0.69


Note: 5-year DFS rates with subdivision into low, average and high selenium concentration intervention vs. placebo: 75.5% (SE, 10.3%) vs. 72.9% (SE, 12.7%), 75.6% (SE, 2.27%) vs. 78.2% (SE, 3.3%), and 72.9% (SE, 4.5%) vs. 80.9% (SE, 5.2%)		low risk
low risk
low risk
low risk		OS (Overall Survival)
Toxicity
Selenium level
DFS (Disease-Free Survival)
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 neckOverall: No significant differences between arms (grade 3 intervention arm 2x, placebo arm 3x, no grade 4)
Only one patient from the intervention arm did not reach CR and died
After 12 months: No significant differences between arms
After 12 months: No significant differences between arms
No significant difference for week 6-8 post-treatment and Follow-up within a year
Overall:
  • Hearing dysfunction n=1 each in the intervention arm and placebo arm;
  • elevated creatinine n=1 in the placebo arm;
  • myelosuppression: anemia in the placebo arm n=1;
  • leukopenia in the intervention arm n=3 and placebo arm n=2;
  • dermatitis in the intervention arm n=2;
  • dry mouth in the placebo arm n=2;
  • dysgeusia in the intervention arm n=2, placebo arm n=1;
  • odyno-/dysphagia in the intervention arm n=1, placebo arm n=2;
  • oral/throat pain in the placebo arm n=2;
  • mucus/sputum intervention arm n=3, placebo arm n=1
some concerns
low risk
low risk
low risk
some concerns
some concerns		Mucositis
Tumor response
PFS (Progression-Free Survival)
OS (Overall Survival)
Quality of life
Toxicity
Muecke et al. (2010): Multicenter, phase 3 trial comparing selenium supplementation with observation in gynecologic radiation oncologyAfter 6 weeks post radiotherapy, levels between arms were comparable
Overall incidence of grade 2 diarrhea: intervention arm 20.5% vs. control arm 44.5% (p = 0.04)
No difference between arms
No difference between arms
Median follow-up of 49 months (range, 0-75): 5-year disease free survival in the intervention arm was 80.1% vs. 83.2% in the control arm, no significant difference; p = 0.74
Median follow-up of 51 months (range 6-75): 5-year overall survival in the intervention arm was 91.9% vs. 83.1% in the control arm, no significant difference; p = 0.34		some concerns
some concerns
some concerns
some concerns
some concerns
some concerns		Selenium level
Toxicity
Performance Status
Quality of life
DFS (Disease-Free Survival)
OS (Overall Survival)
Muecke et al. (2014): Multicenter, phase 3 trial comparing selenium supplementation with observation in gynecologic radiation oncology: follow-up analysis of the survival data 6 years after cessation of randomization10-year disease-free survival intervention arm 80.1% vs. control arm 83.2%; not significant; p = 0.65
10-year overall survival intervention arm 55.3% vs. control arm 42.7%; not significant; p = 0.09		high risk
high risk		DFS (Disease-Free Survival)
OS (Overall Survival)

How does selenium influence survival in cancer? - outcome-based

Which intervention for depression in cancer was investigated in studies with a placebo arm?

 TopicInterventionOutcome nameResults during intervention
Cruciani et al. (2012): L-Carnitine Supplementation for the Management of Fatigue in Patients With Cancer: An Eastern Cooperative Oncology Group Phase III, Randomized, Double-Blind, Placebo-Controlled TrialCarnitineL-Carnitin
Placebo		Fatigue
Fatigue
Depression
Pain
Performance Status
Toxicity
Carnitine level		From Baseline to 8 weeks: improvement in fatigue in intervention arm: Mean difference= -0.96; 95% CI: -1.32,-0.60 and placebo arm: Mean difference= -1.11; 95% CI: -1.44,-0.78; no group difference (z-transformed difference= -0.58; p=0.57)
After 4 weeks: no difference between arms (p=0.61)
After 4 weeks: no difference between arms (p=0.93)
After 4 weeks: no difference between arms for pain intensity: p=0.61, disturbance due to pain: p=0.75
After 4 and 8 weeks: no difference between arms (p=0.13, p=0.63)
No difference between arms for grade 5 side effect (Fisher's exact p=0.64)
After 4 weeks: significant difference between arms, with higher proportion of carnitine deficit in placebo arm (intervention arm: 11%, placebo arm: 33%; p≤.001)
Da Costa et al. (2009): Effectiveness of Guarana (Paullinia cupana) for Postradiation Fatigue and Depression Results of a Pilot Double-Blind Randomized StudyGuarana75 mg of guayana extract
placebo		Depression
Fatigue		NA
NA
Wyatt et al. (2012): Health-Related Quality-of-Life Outcomes: A Reflexology Trial With Patients With Advanced-Stage Breast CancerReflexologyReflexology
Foot massage (LFM)
Conventional therapy, control arm		Quality of life
Unspecified effects
Nausea
Physical functioning
Fatigue
Fatigue
Pain
Depression
Anxiety		NA
NA
NA
NA
NA
NA
NA
NA
NA


Side effects of Cannabis in placebo-controlled studies

 InterventionSide Effects / InteractionsWere side effects systematically recorded
Côté et al. (2016): Improving Quality of Life With Nabilone During Radiotherapy Treatments for Head and Neck Cancers: A Randomized Double-Blind Placebo-Controlled TrialNabilon


+ all patients: additional administration of antiemetics (metoclopramide) and painkillers (acetaminophen (paracetamol), codeine, hydromorphone or transdermal fentanyl) possible
Placebo


+ all patients: additional administration of antiemetics (metoclopramide) and painkillers (acetaminophen (paracetamol), codeine, hydromorphone or transdermal fentanyl) possible		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)		Yes
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 studiesSativex
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%)


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
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		Yes
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 studiesSativex
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%)


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
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		Yes
Grimison et al. (2020): Oral THC:CBD cannabis extract for refractory chemotherapy-induced nausea and vomiting: a randomised, placebo-controlled, phase II crossover trialTHC:CBD
Placebo		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)
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)		Yes
Johnson et al. (2010): Multicenter, double-blind, randomized, placebo-controlled, parallel-group study of the efficacy, safety, and tolerability of THC:CBD extract and THC extract in patients with intractable cancer-related painTHC:CBD
THC
Placebo		Intervention-associated events in n=106 (60%): drowsiness, dizziness, nausea, confusion, vomiting, hypotension, hypercalcemia, increased gamma GT


Most side effects were mild/moderate; no statistical comparisons given; one case of syncope probably related to THC; other events not associated with intervention
Intervention-associated events in n=106 (60%): drowsiness, dizziness, nausea, confusion, vomiting, hypotension, hypercalcemia, increased gamma GT;


Most side effects were mild/moderate; no statistical comparisons given; one case of syncope probably related to THC; other events not associated with intervention
NI		Yes
... further results
Retrieved from "https://camih.med.uni-jena.de/camih/index.php?title=Example_Queries_II&oldid=6916"