Oral Lapacho-Based Medication: An Easy, Safe, and Feasible Support to Prevent and/or Reduce Oral Mucositis During Radiotherapy for Head and Neck Cancer
| Autor: | Cristina Muntoni, Daniela Greto, Daniele Scartoni, Lorenzo Livi, I. Giacomelli, Meacci Fiammetta, M. Baki, Giacomo Zei, Silvia Scoccianti, Sabrina Cappelli |
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| Rok vydání: | 2015 |
| Předmět: |
Male
Cancer Research medicine.medical_specialty medicine.medical_treatment Medicine (miscellaneous) Phases of clinical research Tabebuia medicine Clinical endpoint Mucositis Humans Stomatitis Aged Nutrition and Dietetics business.industry Head and neck cancer Chemoradiotherapy Middle Aged medicine.disease Surgery Discontinuation Radiation therapy Oncology Head and Neck Neoplasms Dietary Supplements Female Plant Preparations business Phytotherapy |
| Zdroj: | Nutrition and Cancer. 67:1249-1254 |
| ISSN: | 1532-7914 0163-5581 |
| DOI: | 10.1080/01635581.2015.1082114 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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