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

Supportive Care in Cancer

Volumn 15, Issue 4, 2007, Pages 427-440

  Barber, Claire ^a   Powell, Roy ^a   Ellis, Annie ^a   Hewett, Julie ^b  

^a ROYAL DEVON AND EXETER NHS FOUNDATION TRUST   (United Kingdom)

^b TORBAY HOSPITAL   (United Kingdom)

Author keywords

Gelclair; Oral mucositis; Pain; Radiotherapy induced toxicity; Swallowing

Indexed keywords

OXETACAINE; SUCRALFATE;

ADULT; ARTICLE; CANCER CENTER; CANCER PATIENT; CANCER RADIOTHERAPY; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; FEMALE; GEL; HEAD AND NECK CANCER; HUMAN; MALE; MEDICAL ASSESSMENT; MUCOSA INFLAMMATION; MULTICENTER STUDY; PAIN ASSESSMENT; PAIN THRESHOLD; PRIORITY JOURNAL; RADIATION INJURY; RANDOMIZED CONTROLLED TRIAL; SINGLE BLIND PROCEDURE; THERAPY EFFECT; TREATMENT OUTCOME; TREATMENT RESPONSE;

ADULT; AGED; ANTI-ULCER AGENTS; DEGLUTITION; DEHYDRATION; DRUG COMBINATIONS; ETHANOLAMINES; FEMALE; HEAD AND NECK NEOPLASMS; HUMANS; HYALURONIC ACID; MALE; MIDDLE AGED; MOUTH MUCOSA; PAIN; PHARMACEUTIC AIDS; POVIDONE; RADIOTHERAPY; STOMATITIS; SUCRALFATE;

EID: 34247846385     PISSN: 09414355     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00520-006-0171-1     Document Type: Article

References (49)

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):40-45
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 71:288-293
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 258:481-487
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 111:1440-1451
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):22-28
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):406-412
11. Chalmers I (1997) What is the prior probability of a proposed new treatment being superior to established treatments? BMJ 314:74-75
12. Chappell C (2005) The nature of quantitative research. http://www.gsu.edu/~mstswh/courses/it7000/papers/the1.htm. Cited Jan 2005
13. Cengiz M, Ozturk D, Akyol F et al (1999) Sucralfate in the prevention of radiation induced oral mucositis. J Clin Gastroenterol 28(1):40-43
14. Clark Callister L (2003) Cultural influences on pain perceptions and behaviors. Home Health Care Manag Pract 15(3):207-211
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):21-33
18. Downie W, Leatham P, Rhind D et al (1978) Studies with pain rating scales. Ann Rheum Dis 37:378-381
19. Edwards D (1998) Types of case study work, a conceptual framework for case-based research. J Humanist Psychol 38:36-71
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):1531-1539
21. Epstein J, Schubert M (1999) Oral mucositis in myelosuppressive cancer therapy. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 88:273-276
22. Epstein J, Stewart K (1993) Radiation therapy and pain in patients with head and neck cancer. Eur J Cancer B Oral Oncol 29B:191-199
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 36:116-120
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 13:401-483
26. Goodwin W Jr, Byers P (1993) Nutritional management of the head and neck cancer patient. Med Clin North Am 77(3):597-610
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):456-457
28. Keogh E, Cochrane M (2002) Anxiety sensitivity, cognitive biases, and the experience of pain. J Pain 3(4):320-329
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):170-173
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 47:149-153
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 15:1235-1238
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):561-572
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):348-352
35. Mercadante S (1996) Nutrition in cancer patients. Support Care Cancer 4 (1):10-20
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 37:275-279
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):423-431
38. National Cancer Institute (2004a) Management of oral complications during and after chemotherapy and/or radiation therapy. http://www.nci.nih.gov/ cancertopics/pdq/supportivecare/oralcomplications/Patient/page5. Cited Jan 2005
39. National Cancer Institute (2004b) Oral complications of chemotherapy and head/neck radiation. http://www.nci.nih.gov/cancertopics/pdq/supportivecare/ oralcomplications/healthprofessional. Cited Dec 2004
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):41-47
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 316:285
43. Smith R (2001a) Chemo-radiotherapy, as compared to radiotherapy alone, significantly increases disease-free and overall survival in head and neck cancer patients after surgery: results of EORTC Phase III Trial 22931. http://www.oncolink.upenn.edu/conferences/article.cfm?c=3&s=12&ss= 62&id=399. Cited Jan 2005
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 34:39-43
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 66:253-262
47. Weissman D, Janjan N, Byhardt R (1989) Assessment of pain during head and neck irradiation. J Pain Symptom Manage 4(2):90-95
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):840-848
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