Trial reportSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2025
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.
Trial report in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
purposeTo 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.
methodsThis 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).
resultsIn 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.
conclusionProtocols R or IR proved to be inferior to the R + IR laser photobiomodulation protocol.
trial registrationBrazilian Clinical Trials Registry ( www.ensaiosclinicos.gov.br ). APPROVAL NUMBER: RBR-9 × 5zrgm. DATE OF REGISTRATION: 12/07/2023.
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