Abstract | UNLABELLED: 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. MATERIALS AND 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. MAIN 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. CONCLUSION: 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.
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Authors | Claire Barber, Roy Powell, Annie Ellis, Julie Hewett |
Journal | Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer
(Support Care Cancer)
Vol. 15
Issue 4
Pg. 427-40
(Apr 2007)
ISSN: 0941-4355 [Print] Germany |
PMID | 17131132
(Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Anti-Ulcer Agents
- Drug Combinations
- Ethanolamines
- Gelclair
- Pharmaceutic Aids
- Sucralfate
- Hyaluronic Acid
- Povidone
- oxethazaine
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Topics |
- Adult
- Aged
- Anti-Ulcer Agents
(therapeutic use)
- Deglutition
(radiation effects)
- Dehydration
(therapy)
- Drug Combinations
- Ethanolamines
(therapeutic use)
- Female
- Head and Neck Neoplasms
(radiotherapy)
- Humans
- Hyaluronic Acid
(therapeutic use)
- Male
- Middle Aged
- Mouth Mucosa
(radiation effects)
- Pain
(drug therapy)
- Pharmaceutic Aids
(therapeutic use)
- Povidone
(therapeutic use)
- Radiotherapy
(adverse effects)
- Stomatitis
(drug therapy, etiology)
- Sucralfate
(therapeutic use)
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