Study register · detailMulticenter Phase III RCT · Cachexia · 2006
Comparison of orally administered cannabis extract and delta-9-tetrahydrocannabinol in treating patients with cancer-related anorexia-cachexia syndrome: a multicenter, phase III, randomized, double-blind, placebo-controlled clinical trial from the Cannabis-In-Cachexia-Study-Group.
Strasser et al.·Journal of Clinical OncologyImpact 1.4
No benefit demonstratedGRADEHigh409 citations
Samplen = 243 Pat.
Duration6 weeks
ControlOral placebo, twice daily for 6 weeks
EndpointVAS and EORTC QLQ-C30
Blindingdoppelblind
DesignMulticenter Phase III RCT
Cannabinoidkombination
THC:CBD2.5:1
Max. dose5.0 mg
Routeoral
”Key finding
Intent-to-treat analysis showed no significant differences between cannabis extract, THC and placebo regarding appetite, quality of life or cannabinoid-related toxicity.
Summary
Multicentre phase III RCT (n=243 randomised; 164 completers); cannabis extract (CE, 2,5 mg THC + 1 mg CBD) and THC 2,5 mg vs. placebo orally 2×/day over 6 weeks in patients with tumour-associated anorexia-cachexia syndrome (CACS). Intent-to-treat analysis: no significant differences between groups for appetite (VAS baseline value 31/100 mm), quality of life (EORTC QLQ-C30 score 30/100) or cannabinoid-related toxicity. Increased appetite was reported by 73 % (CE), 58 % (THC) and 69 % (placebo). Study terminated early by independent data review board. CE well tolerated, but no therapeutic benefit demonstrable over placebo.
P
PopulationAdults with advanced cancer and cancer-related anorexia-cachexia syndrome (CACS), weight loss ≥5% in 6 months, ECOG PS ≤2, n=243 randomised
I
InterventionOral cannabis extract (CE, 2,5 mg THC + 1 mg CBD) or oral THC (2,5 mg), each twice daily for 6 weeks
C
ControlOral placebo, twice daily for 6 weeks
O
OutcomeNo significant difference between CE, THC and placebo regarding appetite or quality of life (ITT analysis); increased appetite reported in 73% (CE), 58% (THC) and 69% (PL)
Confidence in the evidence
Very lowLowModerateHigh
High
The highest of four GRADE levels, the effect estimate is very reliable.
Quality profile
Sample size★★★★★
BlindingDouble-blind
Effect sizeNo benefit
Citations / year★★★★★
Authors
Strasser F, Luftner D, Possinger K, Ernst G, Ruhstaller T, Meissner W, Ko YD, Schnelle M, Reif M, Cerny T
To compare the effects of cannabis extract (CE), delta-9-tetrahydrocannabinol (THC), and placebo (PL) on appetite and quality of life (QOL) in patients with cancer-related anorexia-cachexia syndrome (CACS). Adult patients with advanced cancer, CACS, weight loss (>= 5% over 6 months), and Eastern Cooperative Oncology Group (ECOG) performance status (PS) <= 2 were randomly assigned (2:2:1) to receive CE (standardized for 2.5 mg THC and 1 mg cannabidiol) or THC (2.5 mg) or PL orally, twice daily for 6 weeks. Appetite, mood, and nausea were monitored daily with a visual analog scale (VAS); QOL was assessed with the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (composite score: questions 29 and 30). Cannabinoid-related toxicity was assessed every 2 weeks. Of 289 patients screened, 243 were randomly assigned and 164 (CE, 66 of 95 patients; THC, 65 of 100 patients; and PL, 33 of 48 patients) completed treatment. At baseline, groups were comparable for age (mean, 61 years), sex (54% men), weight loss (32% >= 10%), PS (13% ECOG = 2), antineoplastic treatment (50%), appetite (mean VAS score, 31/100 mm), and QOL (mean score, 30/100). Intent-to-treat analysis showed no significant differences between the three arms for appetite, QOL, or cannabinoid-related toxicity. Increased appetite was reported by 73%, 58%, and 69% of patients receiving CE, THC, or PL, respectively. An independent data review board recommended termination of recruitment because of insufficient differences between study arms. CE at the oral dose administered was well tolerated by these patients with CACS. No differences in patients' appetite or QOL were found either between CE, THC, and PL or between CE and THC at the dosages investigated.