不同光生物调节方案对接受多柔比星-环磷酰胺治疗的乳腺癌患者化疗引起味觉障碍的预防作用：一项III期、随机、三盲非劣效性临床试验

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.

作者信息

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

机构信息

Cancer Institute of Ceará, R. Papi Junior, 1222 - Rodolfo Teófilo, Fortaleza - CE, 60430-230, Brazil.

Department of Dentistry, Unichristus, Fortaleza, Brazil.

出版信息

Support Care Cancer. 2025 Jul 14;33(8):692. doi: 10.1007/s00520-025-09756-4.

DOI:10.1007/s00520-025-09756-4

PMID:40658227

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.

摘要

目的

与已确立的红（R）+红外（IR）激光联合方案相比，评估单独使用红（R）激光或红外（IR）激光方案的非劣效性。

方法

这是一项III期、随机、三盲、非劣效性、安慰剂对照临床试验，由三个研究组组成（每组n = 60）：一组接受R + IR激光，一组仅接受R激光及IR安慰剂，第三组接受IR激光及R安慰剂（2焦耳R激光和3焦耳IR激光），在舌部以对称方式分布于23个点。收集临床病理、社会人口学数据、血液学检查、味觉分析、主观味觉量表（视觉模拟评分法、癌症治疗不良反应通用术语标准、主观味觉测试评估）、生活质量（口腔健康影响程度量表-14）、东部肿瘤协作组一般健康状况、体重指数（BMI）、慢性阻塞性肺疾病、唾液流量及其他副作用。采用卡方检验/费舍尔精确检验和克鲁斯卡尔-沃利斯检验/邓恩检验（组间分析）或弗里德曼检验/邓恩检验（组内分析）（非劣效性界限：双侧p < 0.05）。

结果

在R + IR组中，目标指标无显著降低（p = 0.873），但在R组中，味觉功能有显著降低（p = 0.020）。IR组的视觉模拟评分法（p < 0.001）、癌症治疗不良反应通用术语标准（p < 0.001）、主观味觉测试评估（p < 0.001）和口腔健康影响程度量表-14（p < 0.001）分析结果均显著差于R + IR组。在整个化疗周期中，东部肿瘤协作组参数显示R + IR组（改善20%）相比于R组（改善11.7%）或IR组（改善6.7%）有改善（p = 0.037）。体重指数无差异（p = 0.251），但R + IR组体重显著增加更多（p = 0.044），肥胖发生率未增加（p = 0.850）。R组（p < 0.001）和IR组（p = 0.046）唾液流量减少，但R + IR组未出现（p = 0.369）。