Abstract 935P
Background
Oral mucositis-related pain during concurrent chemoradiation in head and neck cancers is a common problem. Unfortunately, despite its frequency, there is limited evidence for selection of systemic analgesics in this situation. This study was designed to compare the analgesic effect of an NSAID (diclofenac) versus a weak opioid (tramadol).
Methods
This was an open-label, parallel design, superiority randomized controlled study. In this study, head and neck cancer patients undergoing radical or adjuvant chemoradiation, who had grade 1 or above mucositis (in accordance with CTCAE version 4.03) and had pain related to it, were randomly assigned to either diclofenac or tramadol for mucositis-related pain control. The primary endpoint was analgesia after the 1st dose. The secondary endpoints were the rate of change in analgesic within 1 week, adverse events, and quality of life.
Results
128 patients were randomized, 66 to the diclofenac arm and 62 to the tramadol arm. The median AUC for the diclofenac arm and the tramadol arm were 348.936 units (Range 113.64-1969.23) & 420.87 (101.97-1465.96), respectively (P=0.05619). Five patients (8.1%) in the tramadol arm and 11 patients (16.7%) in the diclofenac arm required a change in analgesic within 1 week of starting the analgesic (P=0.184). There was no statistically significant difference in any adverse events between the two arms. However, the rate of any grade renal dysfunction was numerically higher in the diclofenac arm (10.6% versus 4.8%, P=0.326).
Conclusions
In this phase III study, evaluating diclofenac and tramadol for cancer treatment-induced mucositis pain, the analgesic efficacy of both analgesics was found to be similar but diclofenac was associated with a higher rate of renal dysfunction.
Clinical trial identification
CTRI/2016/09/007302.
Editorial acknowledgement
Legal entity responsible for the study
Tata Memorial Hospital.
Funding
Has not received any funding.
Disclosure
The author has declared no conflicts of interest.