Yennurajalingam 2013.
| Study characteristics | ||
| Methods | Randomised, double‐blind, placebo‐controlled trial Study duration: 14 days |
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| Participants | 120 participants (62 intervention, 58 control) with advanced cancer and ≥ 3 symptoms during the previous 24 hours (e.g. pain, fatigue, chronic nausea cluster) with average intensity of ≥ 4 on the Edmonton Symptom Assessment Scale (ESAS) | |
| Interventions | Intervention: 4 mg dexamethasone orally twice per day for 14 days Control: placebo orally twice per day for 14 days |
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| Outcomes | ESAS to assess severity of common symptoms (e.g. pain, fatigue, nausea, depression, anxiety) rated on a NRS of 0 to 10 (0 = no symptoms, 10 = worst possible severity) Functional Assessment of Chronic Illness Therapy‐Fatigue (FACIT‐F), 27 questions, scale 0 to 4 (0 = not at all, 4 = very much) Functional Assessment of Cancer Therapy‐Anorexia‐Cachexia (FAACT), 12‐item symptom‐specific subscale, scale 0 to 4 Hospital Anxiety and Depression Scale (HADS), 14‐item questionnaire |
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| Notes | Fatigue was primary outcome measure Pain as measured by ESAS significantly better on dexamethasone at day 8, but not day 15 |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Randomisation method not described |
| Allocation concealment (selection bias) | Unclear risk | Not stated |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | All members of the research team except the investigational pharmacist and statistician were blinded to treatment assignment throughout the study |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | All members of the research team except the investigational pharmacist and statistician were blinded to treatment assignment throughout the study |
| Incomplete outcome data (attrition bias) All outcomes | High risk | 19 of 62 patients receiving dexamethasone were not evaluable 17 of 58 patients receiving placebo were not evaluable |
| Selective reporting (reporting bias) | Low risk | None detected |
| Other bias | Unclear risk | Sample size: 120 participants; 50 to 199 participants per treatment arm |
BPI: Brief Pain Inventory
ECOG: Eastern Cooperative Oncology Group ESAS: Edmonton Symptom Assessment Scale ITT: intention‐to‐treat IV: intravenous LASA: Linear Analogue Self‐Assessment scale LHRH: Luteinizing Hormone Releasing Hormone
MP: methylprednisolone MPSS: methylprednisolone sodium succinate MSCC: malignant spinal cord compression NRS: numerical rating scale OEI: opioid escalation index P: placebo QoL: quality of life RCT: randomised controlled trial RT: radiation RTOG: Radiation Therapy Oncology Group SCC: spinal cord compression VAS: visual analogue scale