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. 2023 Jun 5;2023(6):CD014915. doi: 10.1002/14651858.CD014915.pub2

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
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
Interventions Nabilone: 1.0 mg/day PO, fixed dosage
Placebo: PO, fixed dosage
Rescue medication: no details reported
Allowed cotherapies: no details reported
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
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.
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.