gelX® Oral Spray is a new treatment system designed to provide a protection shield mucosal and to relieve from pain due to oral mucositis.
Now you can be relieved with innovative new treatment against oral mucositis.It heals the lesions, relieves pain and does not interact with medication.
Oral mucositis involves prolonging hospitalization, increasing insurance costs and significantly aggravating the quality of life of patients.
The treatment of oral mucositis focuses mainly on symptom control and prevention, since to date there is no drug capable of controlling the numerous mucositis events
GelX® Oral Spray is a new treatment system designed to provide a mucosal protection shield and relieve the pain due to mucositis.
Active ingredients and action mechanisms
Oral spray gelX® Oral Spray combines polyvinylpyrrolidone barrier technology (PVP) with a new complex of zinc gluconate and taurine (sulfur-based amino acid). This complex was designed to treat symptoms caused by mucositis for patients suffering from mucositis and mouth ulcers.
GelX® Oral Spray has a mechanical action that is suitable for managing and reducing pain due to the adherence of the product to the surface of the mucous membrane of the mouth, thus relieving the damage caused by chemotherapy and / or radiotherapy. The action of gelX® Oral Spray is based on the formation of an invisible protective barrier on the affected area, protecting the exposed nerve endings (the protective barrier is not perceived by the patient) (Fig. 1).
Polyvinylpyrrolidone (PVP)
- Forms a transparent membrane that protects against water and solutions.
- Protects the exposed mucosa and nerve endings from exogenous pathogens.
- Soothes the pain.
Zinc gluconate
- Zinc is an essential trace element with proven antioxidant action.
Taurine (not essential amino acid)
Taurine is known for its ability to enhance the natural protective barrier and to regulate mucositis-associated proinflammatory cytokines
Combination of zinc-taurine
Its synergistic action multiplies the benefits of the two components, preventing future irritation and helping to quickly relieve pain
The goals of treating patients with gelX® Oral Spray are as follows:
- Tackling or slowing the appearance of mucositis
- Decrease the severity of the ulcerative lesions
- Extending the patient’s wellness period during which cancer therapy can be completed.
GelX® Oral Spray is painless, effective and quick to inhibit mucositis-related pain.
GelX® Oral Spray has an excellent safety profile and no side effects associated with its use have been reported. To date no undesirable effects have been reported from accidental ingestion of the product.
Clinical Studies
GelX Oral Spray, in the prevention and treatment of chemotherapy-induced, oral mucositis in children with cancer.
Pain, swallowing and eating difficulties
Treatment of pain
Pain was reduced in 80% of patients after the treatment with gelX
Swallowing difficulties were reduced in 74% of patients
- Regular feeding with solid food and fluids was no affected during chemotherapy in 12/15 pts and 46 out 60 cycles
- Swallowing difficulties for solid food was recorded only for 3/15 pts short period of 2-3 days for 14 out of 60 cycles of chemotherapy
- Severity of oral mucositis (WHO scale) was imroved
- Duration of mucositis was shorter after including in treatment gelX
- Swallowing adn eating dificulties were reduced, comparing with mucositis symptoms from previous cycles treated with the same therapeutic measures, but without gelX Oral Spray
- Pain was reduced after the treatment with gelX Oral Spray
- There were no delays in treatment caused by severity of oral mucositis
- No complications related to neutropenia occured
Gelx oral spray prevents the appearance of severe mucositis and helps to heal the lesions. It has a rapid and prolonged action against pain caused by oral mucositis during a high risk of chemotherapy in children with cancer.
Institute of oncology “Prof.Dr.Al.Trestioreanu” Bucharest Romania
GelX Oral Spray Reduces Risk of Oral Mucositis in Haematological Patients
1. Prophylactic use reduced mucositis score to (grade 1-2) and a shorter 5-day development period
2. Prophylaxis is the key to the successful development of mucositis
3. It is important to diagnose candidates for mucositis and gelX Oral Spray to be applied at the onset of chemotherapy or the first 24 hours to reduce the likelihood of developing
EHA Learning center Ursuleac I. May 2018
The gelX Oral Spray in the reduction of pain and symptoms that are caused by oral mucositis
Evaluation of 40 patients with solid tumors treated with chemotherapy, combination chemotherapy with radiotherapy.
Each patient used gel 2x prophylaxis 2 times a day, 10 days before the start of treatment and then as treatment 3 times a day for the duration of treatment.
Results 1 month after completion treatment
40 pts with solid tumors chemo
(cis platinum 5FU)/chemoradiation/radiation
30 pts completely resolution of pain & swelling
8 pts no pain but swelling
2 pts mild pain and loss of swelling
The gelX Oral Spray it is safe and effectiveand it can be a new oneapproach to managementand the prevention of oral mucositis.
AIOM Roma, oct 2015, Zannier F, Belloni P, Toniolo D, Cozzi C, A.O.G Salvini Rho(Mi)
Components:
Polyvinylpyrrolidone (PVP)
- Forms a transparent membrane that protects against water and solutions.
- Protects the exposed mucosa and nerve endings from exogenous pathogens.
- Soothes the pain.
Zinc gluconate
- Zinc is an essential trace element with proven antioxidant action.
Taurine (not essential amino acid)
- Taurine is known for its ability to enhance the natural protective barrier and to regulate mucositis-associated proinflammatory cytokines.
Zinc-taurine combination
- Its synergistic effect multiplies the benefits of the two components, preventing future irritation and helping to relieve pain relief.
GelX® Oral Spray is a Class II medical device with a patented zinc and taurine-based composition for the treatment of oral mucositis.
Instructions and methods of administration
Remove the lid and install the spray pump. Turn the spray pump towards the lesions in the mouth and spray it three times. Repeat three times a day. Avoid ingestion of any solid or liquid substance for at least one hour after each application.
Bibliography
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2. Lalla RV, Sonis ST, Peterson DE. Management of oral mucositis in patients who have cancer. Dent Clin North Am 2008;52(1):61-77.
3. Woo SB, Treister NS. Chemotherapy-Induced Oral Mucositis. Available at: http://ww.emedicine.com/derm/topic682.htm. Accessed November 26, 2007.
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8. Agarwl, Pankaj et al (2011) Radiation adn Chemotherapy Complications and their possible management in head and neck region - an overview. Indian Journal of Dental Advancements. 3(3), p.612-6
9. Gorgu, S. Z. (2013) The effect of zinc sulphate in the prevention of radiation induced oral mucositis in patients with head and neck cancer. International Journal of Radiation Research, 11(2), p.111-116
10. Trotti, A. et al (2003) Mucositsi incidence, severity abd associated outcomes in patients with head and neck cancer receiving radiotherapy with or without chemotherapy: systematic literature review. Radiother Oncol, 66(3) p. 253-62
11. Vokurka, Samuel et al (2011) The effect of polyvinylpyrrolidone-sodium hyaluronate gel (Gelclair) on oral microbial colonization and pain control compared with ohter rinsing solutions in patients with oral mucositis afer allogenic stem cell transplantation. Medical Science Monitor, 17(10) p. 572-6
12. Watanabe, Tomoko et al (2010) Polaprezinc prevents oral mucositis associated with radiochemotherapy in patients with head and neck cancer. International Journal of Cancer, 127, p. 1985-1990
13. ECCO VIENNA sep. 2015 poster
14. EHA Learning center Ursuleac I. May 2018
15. AIOM Roma, oct 2015, Zannier F, Belloni P, Toniolo D, Cozzi C, A.O.G Salvini Rho(Mi)