Frytak 1979.
| Study characteristics | ||
| Methods | Randomised, double‐blind, parallel group trial | |
| Participants | 116 people, median age = 61 years. All cannabis naive. THC n = 38 (22 men/16 women), prochlorperazine n = 41 (21 men/20 women), placebo n = 37 (27 men/10 women) Tumour types: colorectal cancer (28 people), gastric cancer (7 people), liver cancer (2 people), miscellaneous (1 person), gastric surgery (5 people), hepatic metastasis (20 people) Chemotherapy regimens: 5‐fluorouracil and semustine or 5‐fluorouracil and semustine plus triazinate, razoxane, doxorubicin or vincristine. 5‐fluorouracil 300‐350 mg/m2 IV for 5 days. Semustine 110‐175 mg/m2 day 1 only Chemotherapy emetogenicity: moderate |
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| Interventions | Dronabinol 15 mg on day 1, 2 hours prior to chemotherapy, then 2 and 8 hours after initiation of chemotherapy. Then 3 times daily x 3 days orally, n = 38 Prochlorperazine 10 mg on day 1, 2 hours prior to chemotherapy, then 2 and 8 hours after initiation of chemotherapy. Then 3 times daily x 3 days orally, n = 41 Placebo n = 37 |
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| Outcomes | Episodes of nausea and vomiting during 24 hours, sedation, feeling high; withdrawal due to intolerable central nervous system toxicity or excessive vomiting | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Table of random numbers |
| Allocation concealment (selection bias) | Low risk | Drugs dispensed in individual packets identified by code number |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Only 1/117 (0.8%) participants withdrew. After day 1, 10/38 (26%) participants withdrew in THC group, 5/41 (12%) participants withdrew in prochlorperazine group, 3/37 (8%) participants withdrew in placebo group |
| Selective reporting (reporting bias) | Low risk | Data reported for primary outcome |
| Other bias | Low risk | Groups were balanced at baseline |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | "Identical opaque gelatin capsules" |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Blinding assumed as study reported as "double‐blind" |