Study of the use of biophotonics in oral mucositis

Not Applicable

• Conditions: neoplasms; C23.550.291.500.500; C07.465.864

• Registration Number: RBR-2bhf37x
• Lead Sponsor: niversidade Federal da Bahia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-02-25
• Study Completion: 2022-03-20
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruitment completed
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Patients aged 18 years or older; with stable lesions undergoing Chemotherapy and/or Radiotherapy; who agreed to participate in the research by signing the Free and Informed Consent Form

Exclusion Criteria

Patients who were receiving medication for the treatment and prevention of mucositis; unable to comply with the treatment procedure or with the oral hygiene protocol; who leave their group by free decision, during the research period; who modify chemotherapy or radiotherapy protocols in cancer treatment; who have worsening ulcers and, therefore, receive specific medication for mucositis; who are hospitalized due to the worsening of their oncological condition.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
An analgesic effect of laser therapy is expected. Using as an evaluation method the application of the Visual Analogue Scale (VAS) for pain.;It is expected to find an improvement in the degree of oral mucositis that will be evaluated taking into account a 4-level graduated classification proposed by the World Health Organization (WHO) (I burning, erythema ; II erythema, ulcer, solid diet; III confluence of ulcers, liquid diet; IV oral feeding is not possible, liquid diet). Through digital images obtained before the beginning of the digital camera treatments. For the realization of the digital photographs, a metallic apparatus in order to standardize a distance of 30 centimeters between the camera and the ulcer surface. A millimeter ruler will also be used, which will be photographed together with the wound so that the image of the wound can be adjusted to a scale of actual size by the image analysis program.