Phase IIb Randomized, Placebo-Controlled, Dose-Escalating, Double-Blind Study of Cannabidiol Oil for the Relief of Symptoms in Advanced Cancer (MedCan1-CBD)

Abstract

PURPOSE To determine whether cannabidiol (CBD) oil can improve symptom distress in patients with advanced cancer receiving palliative care. METHODS Participants were adults with advanced cancer and symptom distress (Edmonton Symptom Assessment Scale [ESAS] total score of ≥ 10/90) who received titrated CBD oil 100 mg/mL, 0.5 mL once daily to 2 mL three times a day, or matched placebo for 28 days. The primary outcome was ESAS total symptom distress score (TSDS) at day 14. Response was defined as a decrease in TSDS by ≥ 6 at day 14. Secondary outcomes were ESAS TSDS over time, individual symptom scores, patient-determined effective dose, opioid use, Global Impression of Change, depression, anxiety, quality of life, and adverse events. RESULTS Of the 144 patients randomly assigned, the planned sample size of 58 participants on CBD and 63 on placebo reached the primary analysis point (day 14). The unadjusted change in TSDS from baseline to day 14 was –6.2 (standard deviation, 14.5) for placebo and –3.0 (standard deviation, 15.2) for CBD with no significant difference between arms ( P = .24). Similarly, there was no detected difference in proportion of responders (placebo: 37 of 63 [58.7%], CBD: 26 of 58 [44.8%], P = .13). All components of ESAS improved (fell) over time with no difference between arms. The median dose of participant-selected CBD was 400 mg per day with no correlation with opioid dose. There was no detectable effect of CBD on quality of life, depression, or anxiety. Adverse events did not differ significantly between arms apart from dyspnea that was more common with CBD. Most participants reported feeling better or much better at days 14 (53% CBD and 65% placebo) and 28 (70% CBD and 64% placebo). CONCLUSION CBD oil did not add value to the reduction in symptom distress provided by specialist palliative care alone.

Quality of life beyond measure: Advanced cancer patients, wellbeing and medicinal cannabis

“…A qualitative sub-study-using semi-structured interviews-was embedded within three MC trials conducted by the broader research team (Good et al, 2020;Hardy et al, 2020Hardy et al, , 2022. Using purposive sampling techniques in 2019-2020, we identified potential interviewees from two palliative care patient cohorts: those who were eligible but declined participation in one of three consecutively-run MC RCTs; and patients who were eligible and consented to trial participation and who were subsequently randomised to a placebo or intervention (THC and/or CBD investigational product) arm, with continued use of existing medications.…”

Cannabis and Cannabinoids in Adults With Cancer: ASCO Guideline

“…After applying the eligibility criteria, 16 remained: 11 systematic reviews 24,25,[27][28][29][30]32,[37][38][39][40] and five RCTs or cohort studies not captured by the included systematic reviews. 21,26,[41][42][43] After the completion of the literature search, the Multinational Association for Supportive Care in Cancer (MASCC) published two additional cannabis systematic reviews, one on psychological symptoms 33 and one on cancer pain. 44 These publications were added to the current review.…”

“…a None Low weight or poor appetite 30,31 Low for dronabinol, nabilone, THC/CBD extract, THC -a None Quality of life 21,30,32 Low for THC, THC/CBD, dronabinol, nabilone, and CBD…”

Potential, Limitations and Risks of Cannabis-Derived Products in Cancer Treatment

“…In a randomised, placebo-controlled, dose-escalating, double-blind phase IIB trial, the effect of CBD oil was studied in 144 patients with advanced cancer and receiving palliative care [ 120 ]. No detectable effect of CBD oil was found on the quality of life, depression or anxiety.…”