Clinical Evidence
Study Four
An audit of the efficacy of Gelclair® for mouth pain in patients undergoing radiotherapy or chemotherapy
McLean M.
Poster presented at the British Association of Head and Neck Oncology Nurses National Study Day on Sharing Good Practice in Head and Neck Cancer Nursing, 12 June 2009.
Study Outline
Twenty−six patients with Grade 2 oral mucositis were given Gelclair® to evaluate its effect on reducing the pain of oral mucositis, increasing functionality and reducing the need for concomitant analgesic consumption. Results were obtained for 16 patients who completed the full 7−day study.
Patients were treated for 7 consecutive days with Gelclair, 1 application 3 times a day, between meals. Evaluations were carried out at a first review assessment with a second follow up review 3–7 days later, considering the following parameters:
- Patients were asked to score their pain according to a scale where 0 = no pain, to 10 = worst pain imaginable (unbearable).
- Patients were asked to score their ability to eat and drink comfortably according to a 6-point scale, where a reduction in functionality reflects an improvement in comfortable eating.
- Necessary dosage of concomitant analgesics.
Results
- Pain: by the end of day 3, the average pain score had reduced from 6.6 before treatment to 4.2, a reduction of 36% (p=0.0021).
- Pain: by the end of day 7, the average pain score had decreased from 6.6 to 2.4, a decrease of 4.2 points, signifying an average pain score reduction of 63% at the end of the 7−day assessment period (p<0.0001).
- Analgesic consumption: by the end of day 3, the average number of analgesic doses taken by patients had reduced from 4.2 to 2.3, an average reduction of 46% (p=ns). By the end of day 7, the average number of analgesic doses had reduced to 2.4, an average reduction of 43% (p=ns).
- Functionality: Gelclair® treatment enabled a more comfortable intake of food and fluids by the end of day 7, functionality scores were reduced by an average of 17% (p=ns).
Patients' Response
Reporting of side effects
Medical device adverse incidents should be reported to the MHRA. Reporting information can be found at https://yellowcard.mhra.gov.uk/. Any adverse event should also be reported to Pharmacovigilance at Alliance Pharmaceuticals Limited
Tel: 01249 466 966 or email: [email protected]
