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Example Queries II

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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)

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

 TopicDosage and regimeOutcome 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-carnitine was a standardized commercial preparation of 10 g of levocarnitine inert salt in 100-mL solution

2g (2x 1g) daily oral Duration: 8 weeks
2g (2x 1g) daily oral

Duration: 8 weeks		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 StudyGuaranaDaily for 14 days

Cross-over: 14 days of placebo
Daily for 14 days

Cross-over: 75 mg of guayana extract daily for 14 days		Depression
Fatigue		NA
NA
Wyatt et al. (2012): Health-Related Quality-of-Life Outcomes: A Reflexology Trial With Patients With Advanced-Stage Breast CancerReflexology30min., 1x week, 4 weeks in total
30min., 1x week, 4 weeks in total
30min., 1x week, 4 weeks in total		Quality of life
Unspecified effects
Nausea
Physical functioning
Fatigue
Fatigue
Pain
Depression
Anxiety		NA
NA
NA
NA
NA
NA
NA
NA
NA
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