ORASOL PLUS, IN UNO STUDIO RANDOMIZZATO, SI DIMOSTRA EFFICACE NEL RIDURRE LA STOMATITE DA EVEROLIMUS

di R. Galante

Pubblicato su tumori journal

Use of a natural multicomponent mouthwash plus oral hygiene vs oral hygiene alone to prevent everolimus-induced stomatitis: the STOP multicenter, randomized trial

Abstract
Background: Stomatitis is highly prevalent in patients with cancer treated with the mammalian target of
rapamycin inhibitor everolimus; it usually has an early onset and may compromise treatment dose intensity and patients’ quality of life. Within the randomized controlled Stomatitis Prevention trial (STOP, ISRCTN14568888), we investigated the possibility of using a commercial natural multicomponent mouthwash (Orasol Plus®) to prevent the development of stomatitis of any grade in patients with advanced renal cell carcinoma (RCC) treated with everolimus.
Methods: Overall, 62 patients were randomized to receive either Orasol Plus in addition to oral hygiene or oral hygiene alone (31 patients per treatment arm).
Results: In the whole study population, 28 episodes of stomatitis were observed (41.9%); in only 2 patients, stomatitis occurred more than once (2 episodes). As expected, the episodes of stomatitis occurred early in the course of treatment with everolimus. Treatment with Orasol Plus prevented the onset of everolimus-induced stomatitis: only 8 episodes of stomatitis were observed in the treated group with Orasol Plus in addition to oral hygiene vs 20 episodes in the group treated with oral hygiene only (p = 0021). Also, a reduction in the average duration of mucositis in patients treated with Orasol Plus compared to patients treated with oral hygiene only was observed (8 days vs 11.2 days, p = 0.0416).
Conclusion: This study showed that the use of a natural multicomponent mouthwash coupled with regular oral hygiene was able to reduce the severity and duration of everolimus-induced stomatitis in patients with RCC.

Tumori Journal

USE OF A NATURAL MULTICOMPONENT MOUTHWASH PLUS ORAL HYGIENE VS ORAL HYGIENE ALONE TO PREVENT EVEROLIMUS-INDUCED STOMATITIS: THE STOP MULTICENTER, RANDOMIZED TRIAL

Pubblicato su Tumori Journal

di: Camillo Porta, Elena Verzoni, Silvia Zai, Caterina Messina, Vittorio Ferrari, Nicole Gri  and Giuseppe Procopio 


Abstract
Background: Stomatitis is highly prevalent in patients with cancer treated with the mammalian target of
rapamycin inhibitor everolimus; it usually has an early onset and may compromise treatment dose intensity and patients’ quality of life. Within the randomized controlled Stomatitis Prevention trial (STOP, ISRCTN14568888), we investigated the possibility of using a commercial natural multicomponent mouthwash (Orasol Plus®) to prevent the development of stomatitis of any grade in patients with advanced renal cell carcinoma (RCC) treated with everolimus.
Methods: Overall, 62 patients were randomized to receive either Orasol Plus in addition to oral hygiene or oral hygiene alone (31 patients per treatment arm).
Results: In the whole study population, 28 episodes of stomatitis were observed (41.9%); in only 2 patients, stomatitis occurred more than once (2 episodes). As expected, the episodes of stomatitis occurred early in the course of treatment with everolimus. Treatment with Orasol Plus prevented the onset of everolimus-induced stomatitis: only 8 episodes of stomatitis were observed in the treated group with Orasol Plus in addition to oral hygiene vs 20 episodes in the group treated with oral hygiene only (p = 0021). Also, a reduction in the average duration of mucositis in patients treated with Orasol Plus compared to patients treated with oral hygiene only was observed (8 days vs 11.2 days, p = 0.0416).
Conclusion: This study showed that the use of a natural multicomponent mouthwash coupled with regular oral hygiene was able to reduce the severity and duration of everolimus-induced stomatitis in patients with RCC.
Trial registration number: ISRCTN14568888

“EVALUATION OF THE USE OF ORASOL PLUS®, A MOUTHWASH BASED ON PLANT EXTRACTS, IN MUCOSITIS IN PATIENTS WITH BREAST CANCER RECEIVING CHEMOTHERAPY“

Pubblicato su advances in hematology and oncology research

Abstract
Breast cancer is the first and most common cancer in women and represents the leading cause of female cancer death. To treat cancer, the treatment that is giving more results is the conventional polychemotherapy with numerous other substances that have specific action, called target therapy. During the treatment of breast cancer, chemotherapy drugs lead to the frequent detection of side effects, first of all, the Oral Mucositis. Oral mucositis (OM) is a common in cancer therapy, found in a percentage of 15-40%, and cause severe sequelae and strong impact on a patient’s quality of life (QoL), health care costs, and ultimately outcome by influencing the treatment dose. There are some and limited therapeutic options to  help reduce the severity of OM. Our study evaluated the action of a mix of natural supplements (swallowable solution,
Orasol plus®, for reduction of mucositis during chemotherapy, with Lapacho (Tabebuia Avellanedae Lorentz ex Griseb.), Camellia Sinensis L. Kuntze, Calendula Officinalis L, Malva Sylvestris L, Sisymbrium Officinale (L) Scop, Plantago Major L e Propoli) in 15 breast cancer patients under treatment with chemotherapy and target therapy. No patients had stopped the treatment because of mucositis. From 11 patients that have mucositis during treatment, 5 had complete remission at the and of the first cycle in the 4 patients who took Orasol Plus®, as a preventive measure, none developed mucositis during antiblastic treatments. The data of our study depose for the effectiveness of Orasol Plus® in the treatment of oral mucositis, in patients undergoing chemotherapy for breast cancer. They need a larger study to insert Orasol Plus® in a standardized pathway in the treatment of oral mucositis during chemotherapy.

ORASOL PLUS PREVIENE/RIDUCE LE MUCOSITI DA CHEMIO-RADIOTERAPIA

Pubblicato su nutrition and cancer 2015, 67(8), 1249–1254

Oral Lapacho-Based Medication: An Easy, Safe, and Feasible Support to Prevent and/or Reduce Oral Mucositis During Radiotherapy for Head and Neck Cancer.

Abstract

The aim of our Phase II study is to demonstrate the benefits, safety, and tolerance of Orasol Plus, an easy and feasible Lapacho-based medication.  Orasol Plus is a nutritional, swallowable solution, useful to support the defenses of the oropharyngeal mucosa. Between January and June 2014, 40 consecutive adult patients affected by head and neck cancer were enrolled. Orasol Plus was administered 3 times a day from the first day till the end of radiotherapy. Primary endpoint was to evaluate tolerance and safety of Orasol Plus; secondary endpoint was to evaluate the effect of Orasol Plus on the incidence of treatment discontinuation.  Nearly all patients used Orasol Plus easily till the end of radiotherapy without interruptions. Only 11 (27.5%) patients developed oral mucositis (OM) Grade 2 and only 4 (10%) patients OM Grade 3, no patient developed OM Grade 4. No patient discontinued radiotherapy because of OM. Orasol Plus was well tolerated and the compliance of patients was optimal,  mainly due to the fact that it can be swallowed. Data from our study are encouraging and they need to be confirmed by a Phase III study.

Fonte: www.ncbi.nlm.nih.gov

ORASOL PREVIENE LE MUCOSITI IN PAZIENTI SOTTOPOSTI A TRAPIANTO AUTOLOGO

Presentazione orale a ebmt 2013 – londra

Retrospective analysis of two cohorts of pts treated with Benzidamine or Orasol for mucositis prophylaxis affected by lymphoma and multiple myeloma undergoing autologous stem cell transplant (aHSCT) following melphalan (Mel) containing regimen

Background: Oral mucositis (OM) is one of the most common side effect of HSCT due to high dose chemotherapy. Mel is widely used in conditioning regimen known to have toxicity on the mucosa which can lead to complications. No oral solution has been shown to be superior to the other in the treatment of OM. Orasol has been recently introduced in the clinical area as nutritional supplement with antinflammatory, analgesic and antifungal activity with no alcohol so can be swallowed,allowing patient(pt)compliance and with activity on the esophageal mucosa.

Primary objective: compare the efficacy between treatment with Orasol to Benzidamine in the OM prophylaxis in pt undergoing aHSCT following HDMel. Secondary objective :to confront outcomes related to use of supportive drugs and days of hospitalization.

Methods: We have performed a retrospective analysis on pts receiving aHSCT from 2011 to 2012 following a Mel containing conditioning regimen and receiving Benzidamine (Group 1) or Orasol (Group 2). Each pt had a daily evaluation of OM according to WHO criteria. The treatment with both solutions was started the day before the conditioning regimen until the end of hospitalization.

Results: We reviewed data of 32 pt.16 pt received treatment with Benzidamine and 16 pt received treatment with Orasol. 7 pts in Group1 had OM WHO grade 0 and 9 pts had a OM grade1.At the end of treatment 1 pt had grade 0 OM,11 pts grade 1;3 pts grade2and 1 pt grade 3. In Group2,at the beginning of treatment 8 pts had grade 0 OM;8 pts had grade1,while at the end of treatment 14 pts had OM grade 0 and 2 had G1. The prophylactic antifungal therapy was given to all pts;6 pts from Group1 (37.5%) received antifungal therapy with liposoma Amfotericine B for worsening of mucositis while in group 2 the antifungal therapy was given to 2 pts. (12.5%). Morphine was administered to 7 pts from Group1 (43,75%) and to only 1 pt (6,25%) from Group2. In Group 1 the median duration of hospitalization was 20,9 days, while in Group2 it was 19,7days.

Conclusions: In our sample we observed that prophylactic treatment with Orasol appears to allow a better protection of oral mucosa compared with Benzidamine allowing, in case of mucositis reduction in the use of systemic analgesic and antifungal therapy. No significant difference was observed in days of hospitalization.

Fonte: Bone Marrow Transplantation Volume 48 supplement 2 april 2013 P. S 462