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Use of Red Propolis from Alagoas for the treatment of injuries resulting from the treatment of oral cancer

Oral cancer: early diagnosis and care for injuries resulting from cancer treatment using technological products based on Red Propolis from Alagoas

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-10d3bt7g
Enrollment
Unknown
Registered
2023-07-03
Start date
2023-04-15
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mouth Neoplasms

Interventions

This is a two-arm, double-blind, randomized controlled clinical trial. A total of 40 people who meet the eligibility criteria will be allocated. The patients will be included according to the flow, al
GP1: patients being treated for oral and oropharyngeal cancer with grade 2 mucositis and who will use Photobiomodulation (FBM) plus placebo film) and GP2: (intervention: patients being treated for ora

Sponsors

Centro de Estudos Superiores de Maceió-CESMAC
Lead Sponsor
Centro de Estudos Superiores de Maceió-CESMAC
Collaborator

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Participants of both sexes; aged between 18 and 64 years; under antineoplastic treatment; with oral and oropharyngeal cancer that fits into at least one of the following International Disease Classifications - ICD C01, C02, C03, C04, C05, C06, C07, C08, C09 or C10

Exclusion criteria

Exclusion criteria: Research participants with intellectual or non-collaborative difficulties that may hinder the use of the propolis-based orodispersible film and participation in complementary exams; pregnant research participants, as there is not enough evidence on the safe use of low power laser and red propolis from Alagoas for this group; research participants who present with severe immunosuppression and inability to leave the hospital environment because they are not responsive to the therapies used in the study; participants who refuse to sign the TCLE and participants who are allergic to film components (propolis and Crustaceans)]

Design outcomes

Primary

MeasureTime frame
It is expected to find an improvement in pain, within a period of 7 days, verified through the visual analogue pain scale (VAS), from the verification of a variation of at least 30% in the measurements from the beginning of the symptoms to the end of the period of treatment.;It is expected to find an improvement in healing, in a period of 7 days, verified by the healing of the lesions accompanied by clinical images photographed using a Z Flip 3 cell phone, based on the verification of a variation of at least 50% in the measurements since the onset of symptoms until the end of the treatment period.

Secondary

MeasureTime frame
secondary outcomes are not expected

Countries

Brazil

Contacts

Public ContactSonia Ferreira

Centro Universitário Cesmac

sonia.ferreira@cesmac.edu.br+55(82)32155119

Outcome results

None listed

Source: REBEC (via WHO ICTRP)