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Influence of protocols with Lasertherapy for the prevention of chemotherapy-induced dysgeusia in patients with breast cancer

Influence of different photobiomodulation protocols on prevention of chemotherapy-induced dygeusia in patients with breast cancer treated with doxorubicine-cyclophosphamide and taxans: Phase III clinical trial, randomized, triple blind.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-9x5zrgm
Enrollment
Unknown
Registered
2023-12-07
Start date
2021-08-03
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

Breast malignant neoplasm

Interventions

180 patients with breast cancer undergoing chemotherapy treatment with the AC-T protocol (doxorubicin + cyclophosphamide + taxanes) will be selected, randomly allocated through randomization, divided
D028022

Sponsors

Universidade Federal do Ceará
Lead Sponsor
Instituto do Câncer do Ceará - ICC
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients over 18 years old; breast cancer stages II, III and IV; adjuvant, neoadjuvant or palliative; treatment with drugs Doxorubicin, Cyclophosphamide and Taxol

Exclusion criteria

Exclusion criteria: Radiotherapy to the head and neck; smokers; anemia; untreated diabetes mellitus; after COVID-19

Design outcomes

Primary

MeasureTime frame
To evaluate the reduction and/or prevention of changes in taste through the method of applying laser therapy prior to chemotherapy with different protocols, Red (V) with 2J + Infrared (IV) 3J, Placebo V + IV application and Placebo IV + application de V. Based on the analysis using the ANOVA-RM/Bonferroni, Friedman/Dunn, chi-square/Fisher's exact tests using the SPSS 20.0 software, adopting a 95% confidence level, we identified that the incidence of Dysgeusia increased from the third QT cycle (p<0.001) and taste sensitivity events <50% were directly associated with the number of chemotherapy cycles (p<0.001), LBI protocols V(+placebo) and IV(+placebo ) (p<0.001) were inferior to the V+IV protocol in subjective (p<0.001) and objective tests (p<0.005).—

Secondary

MeasureTime frame
No secondary outcomes are expected.—

Countries

Brazil

Contacts

Public ContactCássia Emanuella Malta

Universidade Federal do Ceará

cassiaemanuellan@gmail.com+55-085-987152625

Outcome results

None listed

Source: REBEC (via WHO ICTRP)