Abstract 339P
Background
Oral mucositis related pain during CTRT in head and neck cancers is a common problem. Unfortunately, in spite of it being common, there is limited evidence for selection of systemic analgesic in this situation. Hence, 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 in diclofenac and 62 in 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 2 arms. However, the rate of any grade of renal dysfunction was numerically higher in diclofenac arm (10.6% versus 4.8%, p=0.326).
Conclusions
In this phase III study, evaluating diclofenac and tramadol for CRIM pain, the analgesic efficacy of both analgesics was found to 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.
Resources from the same session
210P - Prognostic value of sarcopenia in metastatic renal cell carcinoma patients: A systematic review
Presenter: Angeline Tancherla
Session: e-Poster Display Session
211P - The impact of low muscle mass to overall survival in bladder cancer patients undergoing chemotherapy: A systematic review and meta-analysis
Presenter: Karunia Japar
Session: e-Poster Display Session
212P - Stage I non-seminoma testicular cancer: Adjuvant management and outcomes
Presenter: Gaik Tin Quah
Session: e-Poster Display Session
213P - Stage I seminoma testicular cancer: Predictors of relapse and outcomes for adjuvant carboplatin vs active surveillance
Presenter: Gaik Tin Quah
Session: e-Poster Display Session
214P - Study of treatment outcome in adults with TFE related RCC
Presenter: Ajaykumar Singh
Session: e-Poster Display Session
215P - Analysis of spatial heterogeneity of responses in metastatic sites with nivolumab in renal cell carcinoma
Presenter: Venkata Pradeep Babu Koyyala
Session: e-Poster Display Session
216P - Clinical profile and treatment outcome of testicular seminoma treated at tertiary care centre in Chennai
Presenter: Sivasubramaniam Kumaravelu
Session: e-Poster Display Session
220P - A cost-effectiveness analysis of systemic therapy for metastatic hormone-sensitive prostate cancer
Presenter: Winnie Sung
Session: e-Poster Display Session
221P - Patient-reported sexual and urinary function in nonmetastatic castration-resistant prostate cancer (nmCRPC) when treated with apalutamide (APA) vs placebo (PBO) and ongoing androgen deprivation therapy (ADT) in SPARTAN
Presenter: Hiroji Uemura
Session: e-Poster Display Session
222P - Tolerability and treatment response to darolutamide (DARO) in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) in the phase III ARAMIS trial
Presenter: Matthew R. Smith
Session: e-Poster Display Session