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Clinical Trial
. 2025 Jul 14;33(8):692.
doi: 10.1007/s00520-025-09756-4.

Influence of different photobiomodulation protocols on the prevention of chemotherapy-induced dysgeusia in breast cancer patients treated with Doxorubicin-Cyclophosphamide: a phase III, randomized, triple-blinded non-inferiority clinical trial

Cassia Emanuella Nóbrega Malta  1   2 , Marcela Maria Fontes Borges  1 , Giulianna Aparecida Vieira Barreto  1 , Gabriella Julião Alves Costa  1   2 , Lais Oliveira Castro Barroso  1 , André Alves Crispim  1   2 , José Fernando Bastos de Moura  3 , Paulo Goberlânio de Barros Silva  1   2
Affiliations
Clinical Trial

Influence of different photobiomodulation protocols on the prevention of chemotherapy-induced dysgeusia in breast cancer patients treated with Doxorubicin-Cyclophosphamide: a phase III, randomized, triple-blinded non-inferiority clinical trial

Cassia Emanuella Nóbrega Malta et al. Support Care Cancer. .

Abstract

Purpose: To evaluate the non-inferiority of protocols with red (R) or infrared (IR) lasers alone when compared to the already established protocol of R + IR lasers.

Methods: This is a phase III, randomized, triple-blind, non-inferiority, placebo-controlled clinical trial consisting of three study groups (n = 60/group): one receiving R + IR lasers, one receiving only R-laser and IR-placebo and the third with IR-laser and R-placebo (2 J of R-laser and 3 J of IR-laser) in 23-points symmetrically distributed on the tongue. Clinicopathological, sociodemographic data, hematological tests, taste analysis, subjective taste scales (VAS, CTCAE, and STTA), Quality-of-life (OHIP-14), ECOG general health status, body mass index (BMI), CPOD, salivary flow, and other side effects were collected. Chi-square/Fisher's exact tests and Kruskal-Wallis/Dunn (intergroup-analysis) or Friedman/Dunn (intragroup-analysis) tests were used (Margin of non-inferiority: 2-tailed p < 0.05).

Results: In the R + IR group, the objective did not reduce significantly (p = 0.873), but in the R-group, there was a significant reduction of taste function (p = 0.020). VAS (p < 0.001), CTCAE (p < 0.001), STTA (p < 0.001), and OHIP-14 (p < 0.001) analysis in the IR-group was significantly worse than the R + IR group. The ECOG parameter showed an improvement in the R + IR group (20%) compared to the R (11.7%) or IR (6.7%) groups over the course of the CT cycles (p = 0.037). There was no difference in BMI (p = 0.251), but the R + IR group gained significantly more weight (p = 0.044) without an increase in the frequency of obesity (p = 0.850). Groups R (p < 0.001) and IR (p = 0.046), but not R + IR (p = 0.369), showed a reduction in salivary flow.

Conclusion: Protocols R or IR proved to be inferior to the R + IR laser photobiomodulation protocol.

Trial registration: Brazilian Clinical Trials Registry ( www.ensaiosclinicos.gov.br ).

Approval number: RBR-9 × 5zrgm.

Date of registration: 12/07/2023.

Keywords: Breast cancer; Dyseugia; Photobiomodulation; Quality of life.

PubMed Disclaimer

Conflict of interest statement

Declarations. Ethical approval: The study was conducted by ethical principles and guidelines. Informed consent was obtained upon admission to the institution (Hospital Haroldo Juaçaba/Ceará Cancer Institute). To protect patient confidentiality, information and data were anonymized and stored securely. The code of ethics for this study was no. l.4.879.342. Competing interests: The authors declare no competing interests.

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References

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