Wada 1982.
| Study characteristics | ||
| Methods | Randomised, double‐blind, 2‐period cross‐over trial | |
| Participants | 114 people (47 men/67 women) aged 18‐81 years (median = 57 years) Tumour types: lung cancer (23 people), breast cancer (18 people), ovarian cancer (16 people), lymphoma (including Hodgkin's) (12 people), colonic cancer (7 people), prostatic cancer (5 people), adenocarcinoma (5 people), bladder cancer (3 people), melanoma (3 people), pancreatic cancer (3 people), oesophageal cancer (3 people), stomach cancer (3 people), sarcoma (2 people), testicular cancer (2 people), others (9 people) Chemotherapy regimens: adriamycin (66 people), carmustine (2 people), bleomycin (7 people), cisplatinum (40 people), cytoxan (46 people), dactinomycin (1 person), DTIC (7 people), 5‐fluorouracil (29 people), mustine (4 people), MCCNU (6 people), melphalan (1 person), methotrexate (14 people), mitomycin (17 person), procarbazine (7 people), streptozotocin (1 person), tamoxifen (1 person), vinblastine (5 person), vincristine (16 people), VP‐16 (1 person) |
|
| Interventions | Nabilone 2 mg night prior and 1‐3 hours before chemotherapy and then every 12 hours orally, n = 114 Placebo, n = 114 |
|
| Outcomes | Episodes of nausea and vomiting during 24 hours; withdrawal due to adverse effects; lack of efficacy; progressive disease; death; participant preference; episodes of dizziness, drowsiness, euphoria, dysphoria, hypotension, hallucination | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not reported |
| Allocation concealment (selection bias) | Unclear risk | Not reported |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 84/114 (74%) participants completed both the courses, 92/114 (81%) participants were evaluable for efficacy |
| Selective reporting (reporting bias) | Low risk | Data reported for primary outcome |
| Other bias | Unclear risk | Assumed washout period sufficient. Unclear if paired analysis was performed. Unclear if groups were balanced at baseline |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Reported as "double‐blind" |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Blinding assumed as study reported as "double‐blind" |
DTIC: 5‐(3,3‐dimethyl‐1‐triazeno)‐imidazole‐4‐carboxamide; HN2: ; IM: intramuscular; IV: intravenous; MCCNU: methyl lomustine; n: number; THC: delta‐9‐tetrahydrocannabinol.