Comparing pain control and ability to eat and drink with standard therapy vs Gelclair: a preliminary, double centre, randomised controlled trial on patients with radiotherapy-induced oral mucositis.
GOAL OF THE WORK: Oral mucositis (OM) is a functionally destructive complication of aggressive head and neck cancer therapy, often resulting in intense pain, an inability to eat and drink and secondary malnutrition and dehydration. The barrier-forming properties of Gelclair have shown promise in relieving such symptoms. The aim of this randomised-controlled trial was to evaluate the efficacy of Gelclair, as compared to standard therapy, as a means of short-term symptom control for patients suffering from radiotherapy-induced OM.


METHODS
Twenty patients, with radiotherapy-induced OM seen in two oncology centres in Devon, were randomised to either standard therapy (Sucralfate and Mucaine) or Gelclair and assessed over 24 h. Both treatments were taken four times during the 24-h period, 30 min before meals.


RESULTS
No significant difference was found between the Gelclair and standard therapy arms in terms of general pain (F = 1.512, df = 1, 17, ns). There did appear to be a trend towards pain improvement initially after the use of Gelclair, but this did not last for the full 24-h assessment period. There was no significant reduction in pain on speaking (F = 0.261, df = 1, 17, ns) nor an improvement in capacity to eat and drink, although the effects of standard therapy did appear to last longer than the Gelclair.


CONCLUSIONS
This study indicates that Gelclair is no more effective than current standard practice in relieving the pain associated with radiotherapy-induced OM. Nevertheless, observations from this preliminary study warrant further investigation, with a view to shaping the way forward for head and neck cancer practice on a national level.
Barber
Claire
C
RD&E NHS Foundation Trust, Barrack Rd, Exeter, Devon, EX2 5DW, UK. claire.barber@rdehc-tr.swest.nhs.uk
Powell
Roy
R
Ellis
Annie
A
Hewett
Julie
J
D000328:Adult; D000368:Aged; D000897:Anti-Ulcer Agents / Q000627:therapeutic use; D003679:Deglutition / Q000528:radiation effects; D003681:Dehydration / Q000628:therapy; D004338:Drug Combinations; D004983:Ethanolamines / Q000627:therapeutic use; D005260:Female; D006258:Head and Neck Neoplasms / Q000532:radiotherapy*; D006801:Humans; D006820:Hyaluronic Acid / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009061:Mouth Mucosa / Q000528:radiation effects*; D010146:Pain / Q000188:drug therapy*; D010592:Pharmaceutic Aids / Q000627:therapeutic use; D011205:Povidone / Q000627:therapeutic use*; D011878:Radiotherapy / Q000009:adverse effects; D013280:Stomatitis / Q000188:drug therapy* / Q000209:etiology; D013392:Sucralfate / Q000627:therapeutic use
D000897:Anti-Ulcer Agents; D004338:Drug Combinations; D004983:Ethanolamines; C439265:Gelclair; D010592:Pharmaceutic Aids; D013392:Sucralfate; D006820:Hyaluronic Acid; D011205:Povidone; C100289:oxethazaine