Clinical Studies

Gelclair is the most clinically studied and published of all oral gel devices approved for oral mucositis in the US. In clinical trials: Gelclair has been demonstrated to:

  • Effectively relieve pain by creating a protective film that counteracts the overstimulation of nerve 1,2,3
  • Improve the ability to eat and drink by reducing pain. 1,2,4
  • Reduces the need for analgesics, including opioids due to the creation of a protective coating which alleviates irritation of denuded nerves   4,5

Unlike some oral gels it does not contain alcohol, which can be associated with drying or causing a burning sensation.

The De Cordi study demonstrated the efficacy of Gelclair in patients undergoing different chemotherapy treatments.

 

Gelclair 010410_Gelclair

Graph adapted from De Cordi et al.

  • More than the 80% of patients reported a benefit in pain management and functionality (ability to swallow food and liquids).
  • In 57% of patients the grade of mucositis decreased after 3 days of Gelclair application.

Reference:

De Cordi D et al, Presented at the Italian Anti Tumor League III Congress of Professional Oncology Nurses Conegliano, October 10-12, 2001.

In an open label study of hospice patients with oral lesions Gelclair reduced mean pain scores by 92% after the first dose (p<0.005).

 

InnocentiGraphGraph adapted from Innocenti et al.

Reference:

Innocenti et al Efficacy of Gelclair in reducing pain in palliative care patients with oral lesions: Preliminary findings from an open pilot study. Journal of Pain and Symptom Management (2002) 24, 456-457

The Lindsay et al. study demonstrated the efficacy of Gelclair in reducing pain scores in 33 head and neck cancer patients with oral mucositis receiving radiotherapy.

Pain score was reduced by 57% after treatment with Gelclair (average duration 2.29 days), providing pain relief in 85% of patients.

 

Graph adapted from Lindsay.

  • Gelclair was well tolerated and effective in reducing pain associated with oral mucositis.

Reference:

Lindsay G et al. Australian Nursing Journal 2009; 16(9):30-3.

The McLean study demonstrated the efficacy of Gelclair to significantly reduce mouth pain associated with oral mucositis in cancer patients undergoing radiotherapy or chemotherapy.

 

mclean graph

 

  • Pain score was reduced by 63% after seven-day treatment with Gelclair.
  • Gelclair treatment resulted in reduced analgesic consumption due to Gelclair’s ability to lessen oral mucositis pain.
  • Gelclair treatment improved functionality, the ability to eat and drink, due to reduction in oral mucositis pain.

Reference:

McLean M; An audit of the efficacy of Gelclair for mouth pain in patients undergoing radiotherapy or chemotherapy; Presentation at the National Study Day on Sharing Good Practice in Head and Neck Cancer

 

 

References:

  1. De Cordi et al Gelclair: potentially an efficacious treatment for chemotherapy-induced mucositis Presentation at the Italian Anti-tumor League III Congress of Professional Oncology Nurses. Conegliano October 10-12 2001.
  2. Innocenti et al Efficacy of Gelclair in reducing pain in palliative care patients with oral lesions: Preliminary findings from an open pilot study. Journal of Pain and Symptom Management (2002) 24, 456-457
  3. Lindsay et al. The Clinical effectiveness of Gelclair in the management of oral mucositis Australian Nursing Journal 2009; 16 (9):30-3
  4. McLean et al. An audit of the efficacy of Gelclair for mouth pain in patients undergoing radiotherapy or chemotherapy Presentation at the National Study Day on Sharing Good Practice in Head and Neck Cancer Nursing, June 2009, Leeds (UK)
  5. Sabater et al. Management of oral mucositis with an oral protecting agent Dentum 2006; 6 (1):36-4