Zimmermann 2005.
| Methods | Randomised placebo‐controlled, double‐blind trial with 2 parallel arms Recruitment period: unclear Observation period: 2 weeks (for postoperative face swelling) Ethical approval: yes |
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| Participants | Number of patients: eligible: unclear ‐ included: unclear ‐ reported: 20 Drop outs: unclear Inclusion criteria: female and male patients, age >18, with carcinoma of the tongue or floor of the mouth (clinical stage T3 or T4) Exclusion criteria: clinical tumour stage T1 or T2; second malignancy; cardiac oedema; hypoproteinic oedema; acute infections during the past 6 months; regular intake of antioxidants; chronic renal failure; intellectual disability; pregnant women; prison inmates; participants of other clinical studies. Demographics: 18 men ‐ 2 women; age 30 ‐ 74 (mean: 57) years; all patients had histologically confirmed squamous cell cancer (2 pT2, 7 pT3, 8 pT4) Recruitment and setting: monocenter study, Dresden, Germany Informed consent: yes |
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| Interventions | Intervention: 3000 µg sodium selenite solution i.v. on day of surgery; 1000 µg sodium selenite solution i.v. or p.o. on days 1 to 21 after surgery Control: placebo (0.9% sodium chloride solution) all patients: surgical tumour resection in curative intention with bilateral neck dissection |
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| Outcomes | Primary outcome measures: three defined distances and circumferences in the face; selenium levels in whole blood and several other laboratory parameters Assessment of outcome of interest: manual measurement by one investigator at four time points (prior to, immediately after, one week after and two weeks after surgical intervention) |
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| Notes | Intervention: concomitant surgical and non‐surgical interventions with influence on lymphoedema not reported Investigators provided additional information on their interpretation of study results All patients who refused the continuation of study medication due to perceived adverse effects would have been excluded from the final study report according to Leonhardt 2002; according to personal communication no drop‐outs occurred. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Unclear risk | B ‐Unclear |
CRP: C‐reactive protein
d: day
Gy: Gray
µg: microgram
NSAID: non‐steroidal antiinflammatory drugs
p.o.: per os