Study register · detail
No benefit demonstrated
GRADE
Moderate
13 citations
Samplen = 40 Pat.
Duration2 weeks per study arm
ControlPlacebo cream
EndpointEORTC-CIPN20
Blindingdoppelblind
DesignPilot-RCT (doppelblind, placebokontrolliert, Crossover)
Cannabinoidcbd
Routetopisch
Key finding
Topical CBD cream showed no improvement in CIPN symptoms compared to placebo.
Summary
Pilot RCT (n=40, double-blind, crossover), topical CBD vs. placebo cream in established chemotherapy-related peripheral neuropathy (CIPN), 2×2 weeks: EORTC-CIPN20 scores comparable between CBD and placebo (no significant difference). Toxicity scores also similar. Negative result — topical CBD isolate did not improve CIPN symptoms; good tolerability.
P
PopulationAdults with established chemotherapy-induced peripheral neuropathy (CIPN), n=40
I
InterventionTopical CBD isolate cream, applied over 2 weeks (crossover)
C
ControlPlacebo cream (topical, identical crossover design)
O
OutcomeEORTC-CIPN20 scores comparable under CBD vs. placebo, no significant difference; toxicity scores also similar
Confidence in the evidence
Moderate
The third of four GRADE levels, the effect estimate is probably reliable.
Downgraded for
Imprecision
Quality profile
Sample size
★★★★★
Blinding
Double-blind
Effect size
No benefit
Citations / year
★★★★★
Authors
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Abstract
<b>Background:</b> Patients have been known to use cannabinoids for treating established chemotherapy-induced peripheral neuropathy (CIPN) based on anecdotal information and retrospective reports suggesting that such might be beneficial. In response, a double-blinded, placebo-controlled, randomized, pilot clinical trial was developed to evaluate whether resultant data would support a phase III trial for testing whether a cannabidiol (CBD) cream might improve CIPN. <b>Methods:</b> Forty patients with established CIPN were randomized, in a double-blinded manner, to topical CBD or a placebo cream. The study product was applied for 2 weeks, followed by a crossover for 2 weeks. Neuropathy was evaluated using the European Organization of Research and Treatment of Cancer (EORTC)-CIPN20, the Chemotherapy-Induced Peripheral Neuropathy Assessment Tool, and the Global Impression of Change instruments. Side effects were recorded by symptom diaries. <b>Results:</b> The EORTC-CIPN20 scores were similar in the patients receiving CBD versus the placebo. Likewise, the toxicity scores were similar in patients who received the CBD versus the placebo. <b>Conclusions:</b> This pilot trial did not support that the studied CBD isolate cream improved painful established CIPN. It was well tolerated overall. <b>Clinical Trial Registration Number:</b> NCT05388058.
The impediment to action advances action.