Nabilone was not superior to placebo with regard to quality of life and treatment-related symptoms during head and neck radiotherapy.
Summary
Randomised double-blind placebo-controlled study (n=56) of nabilone for improving quality of life and alleviating side effects during radiotherapy in head and neck carcinomas. Nabilone was not superior to placebo: no significant benefit in quality of life (P=,43), pain (P=,60), nausea (P=,71), loss of appetite (P=,33), weight (P=,15), mood (P=,32) or sleep (P=,44). No benefit demonstrable at the dosage used (negative result). Limitation: small sample size, possibly too low a dose.
P
PopulationAdults with head and neck carcinoma undergoing radiotherapy, n=56
I
InterventionNabilone (oral, dosage not explicitly stated) during radiotherapy
C
ControlPlacebo
O
OutcomeNo significant difference in time to 15% deterioration in quality of life (p=0,4279); no significant differences for pain (p=0,6048), nausea (p=0,7105), loss of appetite (p=0,3295), weight (p=0,1454), mood (p=0,3214) or sleep (p=0,4438)
Confidence in the evidence
Very lowLowModerateHigh
Moderate
The third of four GRADE levels, the effect estimate is probably reliable.
<h4>Objectives</h4>Patients treated for head and neck carcinomas experience a significant deterioration of their quality of life during treatments because of severe side effects. Nabilone has many properties that could alleviate symptoms caused by radiotherapy and improve patients' quality of life. The aim of the present study was to compare the effects of nabilone versus placebo on the quality of life and side effects during radiotherapy for head and neck carcinomas.<h4>Methods</h4>Fifty-six patients were randomized to nabilone or placebo. Patients filled the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and the EORTC QLQ-H&N35; three independent questionnaires assessing appetite, nausea, and toxicity; and a visual analog scale for pain. These data were collected before radiotherapy, each week during radiotherapy, and 4 weeks after radiotherapy. Patients were weighed every week.<h4>Results</h4>Nabilone did not lengthen the time necessary for a 15% deterioration of quality of life (P = .4279), and it was not better than placebo for relieving symptoms like pain (P = .6048), nausea (P = .7105), loss of appetite (P = .3295), weight (P = .1454), mood (P = .3214), and sleep (P = .4438).<h4>Conclusion</h4>At the dosage used, nabilone was not potent enough to improve the patients' quality of life over placebo.