Cassia Emanuella Nóbrega Malta, Marcela Maria Fontes Borges, Giulianna Aparecida Vieira Barreto, Gabriella Julião Alves Costa, Lais Oliveira Castro Barroso, André Alves Crispim, José Fernando Bastos de Moura, Paulo Goberlânio de Barros Silva
{"title":"不同光生物调节方案对多柔比星-环磷酰胺治疗乳腺癌患者预防化疗诱导的功能障碍的影响：一项随机、三盲、非劣效性的III期临床试验","authors":"Cassia Emanuella Nóbrega Malta, Marcela Maria Fontes Borges, Giulianna Aparecida Vieira Barreto, Gabriella Julião Alves Costa, Lais Oliveira Castro Barroso, André Alves Crispim, José Fernando Bastos de Moura, Paulo Goberlânio de Barros Silva","doi":"10.1007/s00520-025-09756-4","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>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.</p><p><strong>Methods: </strong>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).</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>Protocols R or IR proved to be inferior to the R + IR laser photobiomodulation protocol.</p><p><strong>Trial registration: </strong>Brazilian Clinical Trials Registry ( www.ensaiosclinicos.gov.br ).</p><p><strong>Approval number: </strong>RBR-9 × 5zrgm.</p><p><strong>Date of registration: </strong>12/07/2023.</p>","PeriodicalId":22046,"journal":{"name":"Supportive Care in Cancer","volume":"33 8","pages":"692"},"PeriodicalIF":2.8000,"publicationDate":"2025-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"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.\",\"authors\":\"Cassia Emanuella Nóbrega Malta, Marcela Maria Fontes Borges, Giulianna Aparecida Vieira Barreto, Gabriella Julião Alves Costa, Lais Oliveira Castro Barroso, André Alves Crispim, José Fernando Bastos de Moura, Paulo Goberlânio de Barros Silva\",\"doi\":\"10.1007/s00520-025-09756-4\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>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.</p><p><strong>Methods: </strong>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).</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>Protocols R or IR proved to be inferior to the R + IR laser photobiomodulation protocol.</p><p><strong>Trial registration: </strong>Brazilian Clinical Trials Registry ( www.ensaiosclinicos.gov.br ).</p><p><strong>Approval number: </strong>RBR-9 × 5zrgm.</p><p><strong>Date of registration: </strong>12/07/2023.</p>\",\"PeriodicalId\":22046,\"journal\":{\"name\":\"Supportive Care in Cancer\",\"volume\":\"33 8\",\"pages\":\"692\"},\"PeriodicalIF\":2.8000,\"publicationDate\":\"2025-07-14\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Supportive Care in Cancer\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1007/s00520-025-09756-4\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"HEALTH CARE SCIENCES & SERVICES\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Supportive Care in Cancer","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s00520-025-09756-4","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"HEALTH CARE SCIENCES & SERVICES","Score":null,"Total":0}
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.
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.
期刊介绍：
Supportive Care in Cancer provides members of the Multinational Association of Supportive Care in Cancer (MASCC) and all other interested individuals, groups and institutions with the most recent scientific and social information on all aspects of supportive care in cancer patients. It covers primarily medical, technical and surgical topics concerning supportive therapy and care which may supplement or substitute basic cancer treatment at all stages of the disease.
Nursing, rehabilitative, psychosocial and spiritual issues of support are also included.
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