Effect of a Novel Soaking Solution Used in Patients With Hand-Foot Syndrome as a Result of Capecitabine Treatment: A Randomized and Self-Controlled Trial

• Published in: Clinical breast cancer 2022-07, Vol.22 (5), p.e685-e690
• Main Authors: Xie, Yuxiu, Wang, Qiong, Hu, Ting, Chen, Renwang, Wang, Jue, Chang, Haiyan, Peng, Xin, Cheng, Jing
• Format: Article
• Language: English
• Subjects: adverse reactions; breast cancer; effectiveness; hand-foot response; oral chemotherapy drugs
• ISSN: 1526-8209; 1938-0666
• DOI: 10.1016/j.clbc.2022.01.009

Hand-foot syndrome (HFS) is a common adverse event in patients receiving capecitabine therapy for breast cancer, and the symptoms of HFS significantly impair patient quality of life. However, currently there are no effective drugs or measures to prevent and alleviate the occurrence of HFS. To assess the effectiveness of a novel soaking solution, a mixture solution of dexamethasone, gentamicin and vitamin B12, in patients with grade 2-3 HFS after capecitabine treatment for breast cancer. Patients with grade 2-3 HFS according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) were enrolled in this randomized, single-center, self-controlled trial. Each patient's right and left hands or feet were individually randomized to soak in either a novel soaking solution (treated hands or feet) or a placebo liquid (control hands or feet) for three times a day, each time for 15 minutes and for four weeks. Effectiveness was evaluated according to CTCAE grades, defined as a reduction of 1 or more CTCAE grades. A total of 60 patients were enrolled. The HFS CTCAE grade of the treated hands and feet at 4 weeks of HFS treatment was significantly decreased compared to that of the control hands and feet (P = .005). Significant differences were also observed between the treatment conditions in terms of the HFS effectiveness rate: treated group 80% and placebo group 51.7% (P = .001). No adverse or unexpected events were observed during the whole trial. Soaking affected hands or feet in a novel soaking solution safely and effectively reduced the severity of HFS following treatment with capecitabine for breast cancer. Capecitabine is currently used as a treatment for advanced breast cancer. However, hand-foot syndrome (HFS) occurs in almost 50% of capecitabine-treated patients. We intervened a total of 60 patients by soaking the enrolled patients soaked each hand or foot in a novel soaking solution (normal saline (1000 ml) + vitamin B12 (6000 IU) + gentamicin (320 mg) + dexamethasone (10 mg)) or placebo for 15 minutes three times a day and the result suggested that a novel soaking solution was an effective method to relieve the symptoms of HFS.