Effectiveness of Trolamine in Preventing Radiotherapy-Related Skin Toxicity in Breast Cancer: A Meta-Analysis and Trial Sequential Analysis Study of Randomized Controlled Trials

OBJECTIVE: To evaluate the efficacy of trolamine in preventing radiotherapy-associated skin toxicity in patients with breast cancer. DATA SOURCES: PubMed, Embase, Cochrane Library, Web of Science, ClinicalTrials.gov, China National Knowledge Infrastructure (CNKI), Wanfang Data, VIP Database, and Chinese Biomedical Literature Database (CBM). STUDY SELECTION: The included randomized controlled trials focused on the incidence of grade 0 to 1 cutaneous toxicity, the incidence of grade 2 cutaneous toxicity, the incidence of grade 2 or higher cutaneous toxicity, and the incidence of grade 3 or higher cutaneous toxicity. DATA EXTRACTION: Data on participant demographics, intervention details, and outcome measures were collected from the selected studies. DATA SYNTHESIS: A total of 10 randomized controlled trials involving 980 patients with breast cancer were included. Results showed that the incidence of grade 0 to 1 skin toxicity was significantly higher in the trolamine group (RR = 1.89; 95% CI [1.05, 3.40]; P = .03), whereas the incidence of grade 2 (RR = 0.51; 95% CI [0.27, 0.96]; P = .04), grade 2 or higher (RR = 0.52; 95% CI [0.31, 0.87]; P = .01), and grade 3 or higher (RR = 0.37; 95% CI [0.23, 0.62]; P = .0001) skin toxicity was significantly lower. Based on the GRADE approach, the quality of evidence was rated as “low” for grades 0 to 1, grade 2, and grade 2 or higher skin toxicity, whereas evidence for grade 3 or higher skin toxicity was rated as “moderate.” CONCLUSIONS: Trolamine significantly reduces the incidence of grade 2 and higher skin toxicity, particularly grade 3 or higher skin toxicity.