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Supportive Care in Cancer
Published in: Supportive Care in Cancer 4/2007

01-04-2007 | Original Article

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

Authors: Claire Barber, Roy Powell, Annie Ellis, Julie Hewett

Published in: Supportive Care in Cancer | Issue 4/2007

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Abstract

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.
Literature
1.
Altman D, Machin D, Bryant T et al (2000) Statistics with confidence, 2nd edn. BMJ, Bristol
2.
Anwander T, Berge S, Appel T et al (2004) Percutaneous endoscopic gastrostomy for long-term feeding of patients with oropharyngeal tumors. Nutr Cancer 50(1):40–45PubMedCrossRef
3.
Barker G, Loftus L, Cuddy P et al (1991) The effects of sucralfate suspension and diphenhydramine syrup plus kaolin–pectin on radiotherapy induced mucositis. Oral Surg Oral Med Oral Path 71:288–293PubMedCrossRef
4.
Bensadoun R, Magne N, Marcy P et al (2001) Chemotherapy and radiotherapy-induced mucositis in head and neck cancer patients, new trends in pathophysiology, prevention and treatment. Eur Arch Otorhinolaryngol 258:481–487PubMedCrossRef
5.
Berndtson M (2001) A preliminary study of Orassist (Gelclair) in the management of oral mucositis. Swedish Hospital Dentistry 3(26):17–21
6.
Bjordal K, Ahlner-Elmqvist M, Hammerlid E (2001) A prospective study of quality of life in head and neck cancer patients. Part II. Longitudinal data. Laryngoscope 111:1440–1451PubMedCrossRef
7.
Borbasi S, Cameron K, Quested B (2002) More than a sore mouth, patients’ experience of oral mucositis. Oncol Nurs Forum 7:1051–1057
8.
Breivik E, Bjornsson G, Skovlund E (2000) A comparison of pain rating scales by sampling from clinical trial data. Clin J Pain 16(1):22–28PubMedCrossRef
9.
Buschel P (2003) Gelclair oral gel. Clin J Oncol Nurs 7(1):109–110
10.
Cella D, Pulliam J, Fuchs H et al (2003) Evaluation of pain associated with oral mucositis during the acute period after administration of high-dose chemotherapy. Cancer 98(2):406–412PubMedCrossRef
11.
Chalmers I (1997) What is the prior probability of a proposed new treatment being superior to established treatments? BMJ 314:74–75PubMed
12.
13.
Cengiz M, Ozturk D, Akyol F et al (1999) Sucralfate in the prevention of radiation induced oral mucositis. J Clin Gastroenterol 28(1):40–43PubMedCrossRef
14.
Clark Callister L (2003) Cultural influences on pain perceptions and behaviors. Home Health Care Manag Pract 15(3):207–211CrossRef
15.
Clarkson J, Worthington H, Eden O (2004) Interventions for preventing oral mucositis for patients with cancer receiving treatment. The Cochrane Library, Issue 3. Wiley, Chichester
16.
De Cordi M, D’andrea P, Giorgiutti E (2001) Gelclair, potentially an efficacious treatment for chemotherapy-induced mucositis. Italian tumour league III congress for professional oncology nurses, Conegliano, 10–12 October 2001
17.
Dodd M, Miaskowski C, Greenspan D et al (2003) Radiation-induced mucositis, a randomized clinical trial of micronized sucralfate versus salt and soda mouthwashes. Cancer Invest 21(1):21–33PubMedCrossRef
18.
Downie W, Leatham P, Rhind D et al (1978) Studies with pain rating scales. Ann Rheum Dis 37:378–381PubMedCrossRef
19.
Edwards D (1998) Types of case study work, a conceptual framework for case-based research. J Humanist Psychol 38:36–71CrossRef
20.
Elting L, Cooksley C, Chambers M et al (2003) The burdens of cancer therapy. Clinical and economic outcomes of chemotherapy-induced mucositis. Cancer 98(7):1531–1539PubMedCrossRef
21.
Epstein J, Schubert M (1999) Oral mucositis in myelosuppressive cancer therapy. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 88:273–276PubMedCrossRef
22.
Epstein J, Stewart K (1993) Radiation therapy and pain in patients with head and neck cancer. Eur J Cancer B Oral Oncol 29B:191–199PubMedCrossRef
23.
Epstien J, Wong F (1994) The efficacy of sucralfate suspension in the prevention of oral mucositis due to radiation therapy. Int J Radiat Oncol Biol Phys 28:693–698
24.
Etiz D, Erkal H, Serin M et al (2000) Clinical and histopathological evolution of Sucralfate in prevention of oral mucositis induced by radiation therapy in patients with head and neck malignancies. Oral Oncol 36:116–120PubMedCrossRef
25.
Flook C, Calman F, Mant M, Subramanian R, O’Connell M (2005) Gelclair vs Benzydamine in a randomised controlled study in patients with oral mucositis due to radical radiotherapy. Support Care Cancer 13:401–483CrossRef
26.
Goodwin W Jr, Byers P (1993) Nutritional management of the head and neck cancer patient. Med Clin North Am 77(3):597–610PubMed
27.
Innocenti M, Moscatelli G, Lopez S (2002) Efficacy of Gelclair in reducing pain in palliative care patients with oral lesions, preliminary findings from an open pilot study. J Pain Symptom Manage 24(5):456–457PubMedCrossRef
28.
Keogh E, Cochrane M (2002) Anxiety sensitivity, cognitive biases, and the experience of pain. J Pain 3(4):320–329PubMedCrossRef
29.
Lee D, Mohit-Tabatabai M, Rush B Jr et al (1995) Stomal seeding of head and neck cancer by percutaneous endoscopic gastrostomy tube placement. Ann Surg Oncol 2(2):170–173PubMedCrossRef
30.
Lievens Y, Haustermans K, Van den Weyngaert D et al (1998) Does Sucralfate reduce the acute side effects in head and neck cancer treated with radiotherapy? A double-blind randomised trial. Radiother Oncol 47:149–153PubMedCrossRef
31.
Loprinzi C, Ghosh C, Camoriano J et al (1997) Phase III controlled evaluation of Sucralfate to alleviate stomatitis in patients receiving fluorouracil based chemotherapy. J Clin Oncol 15:1235–1238PubMed
32.
Malone J, Stephens J, Grecula J et al (2004) Disease control, survival, and functional outcome after multimodal treatment for advanced-stage tongue base cancer. Head Neck 26(7):561–572PubMedCrossRef
33.
Makkonen T, Bostrom P, Vilja P et al (1994) Sucralfate mouth washing in the prevention of radiation-induced mucositis, a placebo-controlled double blind randomised study. Int J Radiat Oncol Biol Phys 4(30):177–182
34.
Martin Villares C, Dominguez Calvo J, San Roman Carbajo J et al (2004) Heavy alcohol intake, malnutrition and head and neck cancer patients. Nutr Hosp 19(6):348–352PubMed
35.
36.
Meredith R, Salter M, Kim R et al (1997) Sucralfate for radiation mucositis. Results of a double blind randomised trial. Int J Radiat Oncol Biol Phys 37:275–279PubMedCrossRef
37.
Naidu M, Ramana G, Rani P et al (2004) Chemotherapy induced and/or radiotherapy induced oral mucositis-complicating the treatment of cancer. Neoplasia 6(5):423–431PubMedCrossRef
38.
39.
40.
Nottage M, McLachlan S, Brittain M et al (2003) Sucralfate mouthwash for prevention and treatment of 5-fluorouracil-induced mucositis, a randomized, placebo-controlled trial. Support Care Cancer 11(1):41–47PubMed
41.
Peterman A, Cella D, Glandon G et al (2001) Mucositis in head and neck cancer, economic and quality of life outcomes. J Natl Cancer Inst Monogr 29:45–51
42.
Roland M, Torgerson DJ (1998) Understanding controlled trials: what are pragmatic trials? BMJ 316:285PubMed
43.
44.
Smith T (2001b) Gelclair, managing the symptoms of oral mucositis. Hosp Med 62(10):623–626
45.
Sonis S (1998) Mucositis as a biological process, a new hypothesis for the development of chemotherapy induced stomatoxicity. Oral Oncol 34:39–43PubMedCrossRef
46.
Trotti A, Bellm L, Epstein J et al (2003) Mucositis incidence, severity and associated outcomes in patients with head and neck cancer receiving radiotherapy with or without chemotherapy: a systematic literature review. Radiother Oncol 66:253–262PubMedCrossRef
47.
Weissman D, Janjan N, Byhardt R (1989) Assessment of pain during head and neck irradiation. J Pain Symptom Manage 4(2):90–95PubMedCrossRef
48.
Wells M (1998) The hidden experience of radiotherapy to the head and neck: a qualitative study of patients after completion of treatment. J Adv Nurs 28(4):840–848PubMed
49.
Worthington H, Clarkson J, Eden O (2004) Interventions for treating oral mucositis for patients with cancer receiving treatment. The Cochrane Library, Issue 3, 2004. Wiley, Chichester
Metadata
Title
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
Authors
Claire Barber
Roy Powell
Annie Ellis
Julie Hewett
Publication date
01-04-2007
Publisher
Springer-Verlag
Published in
Supportive Care in Cancer / Issue 4/2007
Print ISSN: 0941-4355
Electronic ISSN: 1433-7339
DOI
https://doi.org/10.1007/s00520-006-0171-1

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