Mucosadhesive formulation for Oral Mucositis relief (PHASE II and III)

Conditions

Mucositis

Pereira CH, Martins AFL, Morais MO, de Sousa-Neto SS, da Silva ACG, Arantes DAC, De Oliveira Moreira VHL, Valadares MC, Freitas NMA, Leles CR, Mendonça EF.

2024-09-022 citations

10.1007/s00520-024-08842-3

Effects of a mucoadhesive phytomedicine (Curcuma longa L. and Bidens pilosa L.) on radiotherapy-induced oral mucositis and quality of life of patients undergoing head and neck cancer treatment: randomized clinical trial.

Martins AFL, Pereira CH, Morais MO, de Sousa-Neto SS, Valadares MC, Freitas NMA, Leles CR, de Mendonça EF.

2023-08-118 citations

10.1007/s00520-023-07971-5

Papers published before 2007-09-01 may not appear yet. Historical indexing is in progress.

Interventions

Patients with head and neck cancer who will undergo radiotherapy and included in the study will be randomized into three groups: group I (n=100) will receive the medicine as an oral mouthwash solution

Drug

Device

HP4.018

E02.815

Eligibility

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Cancer patients with head and neck cancer; Age greater than 18 years; Programmed to receive radiation therapy; Presence of intact buccal mucosa.

Exclusion criteria

Exclusion criteria: Patients with salivary gland infections or tumors; Patients with Sjögren's syndrome; Buccal mucosa presenting wounds; Indication for chemotherapy alone.

Design outcomes

Primary

Measure	Time frame
The evaluation of the oral mucositis grade will be evaluated through clinical inspection and palpation during the clinical care of the patient in the following clinical moments: 24 hours before radiotherapy, at the 15th and 21st sessions, and at the last session of radiotherapy and phytotherapeutic use. Photographs will also be taken from patients' mouths for evaluation. It is expected that this formulation (intervention) will reduce the degree of oral mucositis (grade I) or not allow this oral alteration (grade 0) to develop in at least 50% of the cases.	—

Measure

Time frame

The evaluation of the oral mucositis grade will be evaluated through clinical inspection and palpation during the clinical care of the patient in the following clinical moments: 24 hours before radiotherapy, at the 15th and 21st sessions, and at the last session of radiotherapy and phytotherapeutic use. Photographs will also be taken from patients' mouths for evaluation. It is expected that this formulation (intervention) will reduce the degree of oral mucositis (grade I) or not allow this oral alteration (grade 0) to develop in at least 50% of the cases.

—

Secondary

Measure	Time frame
It does not apply to this study.	—

Countries

Brazil

Contacts

Public ContactElismauro Mendonça

Hospital Araujo Jorge da Associação de Combate ao Câncer em Goiás

elismaur@ufg.br+55 (62) 3243 7237

Outcome results

None listed