Turcott 2018.
Study characteristics | ||
Methods |
Purpose of the study: improvement of appetite, nutritional status and quality of life in people with lung cancer undergoing chemotherapy or targeted therapy Study setting: 1 outpatient clinic at the National Institute of Cancer Mexico Study period: December 2013 to December 2015 Study design: double‐blind, randomised, placebo‐controlled, parallel‐group design Study duration: no information on baseline period reported, 8 weeks' double‐blind |
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Participants |
Type of cancer: histologically confirmed advanced NSCLC Inclusion criteria: adults with histologically confirmed advanced NSCLC, regardless of current therapeutic scheme, with a good performance status (ECOG 0–2), diagnosed with anorexia Exclusion criteria: known allergy or contraindication for receiving CBs, previously received treatment with CBs, and previously received any other pharmacological treatment for anorexia Nabilone: 14 participants; 21% men; mean age 61.1 (SD 10.6) years; race not reported; type of cancer pain: not reported; pain medication: not reported; previous cannabis use: not reported Placebo: 19 participants; 21% men; mean age 52.6 (SD 11.8) years; race not reported; type of cancer pain: not reported; pain medication: not reported; previous cannabis use: not reported |
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Interventions |
Nabilone: 1.0 mg/day PO, fixed dosage Placebo: PO, fixed dosage Rescue medication: no details reported Allowed cotherapies: no details reported |
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Outcomes |
Proportion of participants reporting no worse than mild pain on treatment at 14 days after start of treatment (typically < 30/100 mm on a 100‐mm VAS or < 3 on an 11‐point NRS): not assessed Patient impression to be much or very much improved: not assessed Withdrawal due to adverse events: no details of assessment reported Combined responder: not assessed Pain relief ≥ 30%: VAS 0–100, time frame not reported; calculated by imputation method Pain relief ≥ 50%: VAS 0–100, time frame not reported; calculated by imputation method Mean pain intensity: VAS 0–100, time frame not reported Sleep problems: EORTC‐QLQ‐C30 and EORTC‐QLQ‐LC13. Scores for the multi‐item functional, symptom scales and the single‐item scales were calculated using a linear transformation of raw scores to produce a range from 0 to 100, as described by EORTC. Subscale Insomnia Depression: not assessed Anxiety: not assessed Daily maintenance opioid therapy dose: not assessed Daily breakthrough opioid therapy dose: not assessed Withdrawals due to lack of efficacy: not reported Nervous system disorders adverse effects: not assessed Psychiatric disorders adverse effects: not assessed Any serious adverse event: not reported |
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Notes |
Funding: nabilone and placebo were donated by Valeant pharmaceutical without any further participation in the trial. Conflicts of interest: authors declared no conflicts of interest. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No details reported. |
Allocation concealment (selection bias) | Unclear risk | No details reported. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No details reported. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No details reported. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No details reported. |
Selective reporting (reporting bias) | Low risk | All outcomes reported as outlined in NCT02802540 |
Selection bias | High risk | Significant differences between nabilone and control group with regard to ECOG status and age at baseline, |
BPI‐SF: Brief Pain Inventory – Short Form; CB: cannabinoid; CBD: cannabidiol; EORTC‐QLQ‐C30: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaires – Cancer; EORTC‐QLQ‐LC: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaires – Lung Cancer; ESAS: Edmonton Symptom Assessment Scale; ITT: intention to treat; NRS: Numeric Rating Scale; NSAID: non‐steroidal anti‐inflammatory drug; NSCLC: non‐small cell lung cancer; PGIC: Patient Global Impression of Change; PO: oral; SD: standard deviation; THC: tetrahydrocannabinol; TSDS: Total Symptom Distress Score; VAS: Visual Analogue Scale.