Influência da fotobiomodulação na prevenção de disgeusia induzida por quimioterapia em pacientes com câncer de mama tratados com doxorrubicina e ciclofosfamida: ensaio clínico triplo cego, randomizado e placebo controlado

Abstract

Introduction: Adverse effects such as altered taste (dysgeusia) can cause malnutrition and consequent negative impact on the quality of life of patients with breast cancer treated with Doxorubicin and Cyclophosphamide (CA). The aim of the present study was to evaluate the efficacy of Photobiomodulation (PBMT) in preventing dysgeusia in patients with breast cancer undergoing CA treatment. Materials and methods: Phase II clinical trial, randomized, triple blind, placebo controlled, guided by CONSORT and registered with REBEC (RBR-9qnm34y). 112 patients with breast cancer treated with CA were treated at the oncology outpatient clinic of the ICC. Patients were randomly divided into two study groups: group treated with 2J of red light and 3J of infrared light (Therapy XT, DMC) in 23 points symmetrically distributed on the tongue every 21 days (one cycle), for four cycles of QT; and placebo group treated in the same way simulating an application in order to blind the patient, evaluator and statistician. Clinical-pathological, sociodemographic data, hematological tests (blood count and creatinine), taste test, taste evaluation analysis (EVA, CTCAE and STTA), quality of life (OHIP-14), general health scores (ECOG), BMI and other adverse effects. A statistical analysis was performed blindly using the tests (ANOVA-RM / Bonferroni, Friedman / Dunn, chi-square / Fisher's exact; SPSS 20.0; p <0.05). Results: The PBMT group has reduced objective loss and taste specification over the first four cycles of chemotherapy (p <0.05). There were lower OHIP-14 scores in the PBMT group (p <0.001) and lower incidence of cachexia (p = 0.020), anorexia (p <0.001), diarrhea (p = 0.040), oral mucositis (p = 0.020) and vomiting (p = 0.008) and tooth mobility (p = 0.003) throughout the protocol. Patients in the PBM group independent of better general health status (ECOG scale) at the end of the study compared to patients in the placebo group (p = 0.037), however, a slight increase in insomnia scores was observed after the fourth CA cycle ( p = 0.035). Conclusion: A PBMT proved to be effective in preventing dysgeusia induced by chemotherapy, avoided weight loss, other adverse effects and contributed to the maintenance of the general health status of patients with breast cancer treated systemically without interfering in cancer planning.