Evaluation of the protective effect of chamomile oral solution on the incidence of neurotoxicity caused by paclitaxel in breast cancer patients.

Neurotoxicity is one of the major complications in cancer patients following paclitaxel-containing regimens. Matricaria chamomilla L., isolated from the German chamomile, has anti-inflammatory and antioxidant features. In this study we evaluated the preventive impact of a chamomile oral formulation against paclitaxel-induced neurotoxicity in cancer patients. In this triple-blind clinical trial, cancer patients on paclitaxel were randomly allocated to chamomile oral solution (n = 40), or the placebo (n = 40) 5 ml three times a day for four courses of chemotherapy starting one day before the paclitaxel injection. At the end of each chemotherapy course, patients in both groups were evaluated and graded according to CTCAE (Common Terminology Criteria for Adverse Events). Also, anxiety and sleep disorder were evaluated at the beginning and end of the study based on Generalized Anxiety Disorder-7 and Pittsburgh Sleep Quality Index criteria, respectively. At the end of the four cycles of chemotherapy, there was no significant difference between the two groups in terms of the neuropathy CTCAE score. In terms of the various components of the sleep questionnaire, only the individual's overall description of sleep quality at the end of the study was significantly better in the treatment group (P = 0.026). Sleep quality was also significantly better (P = 0.027), and the chance of good sleep quality in the intervention group was 4.48 times higher. Regarding the anxiety score, despite a significant decrease in both groups, the difference between the two groups at the end of the fourth course was not significant. Neither group experienced any adverse effects. Although chamomile oral solution did not significantly lessen neuropathy, findings propose that it may significantly ameliorate sleep quality in patients receiving chemotherapy as a low-cost, low-risk treatment. It also has no significant impact on reducing the level of anxiety in cancer patients.