A protocol for efficacy of rikkunshito on chemotherapy-induced nausea and vomiting in patients with uterine corpus or cervical cancer treated with cisplatin-based regimen -placebo-controlled, double-blind, randomized confirmatory study (efficacy of rikkunshito on chemotherapy-induced nausea and vomiting)

Abstract

Background: Current standard treatment of chemotherapy-induced nausea and vomiting (CINV) using standard antiemetics is not sufficient. Rikkunshito, a Japanese traditional herbal medicine, has been shown to ameliorate cisplatin-induced anorexia in animal models, and an exploratory study suggested that rikkunshito had an additive beneficial effect on CINV in patients with uterine corpus and cervical cancer during cisplatin-including chemotherapy. Methods: This multicenter, randomized, double-blind, placebo-controlled confirmatory study will evaluate the potential additive beneficial effect of rikkunshito on CINV in patients treated with standard antiemetics. One hundred-eighty patients aged ≥20 years with uterine corpus or cervical cancer who are scheduled for treatment with a cisplatin-based regimen as initial chemotherapy will be enrolled across 17 institutions in Japan. Patients will be randomized with a 1:1 equal allocation ratio to the rikkunshito or the placebo group. The primary endpoint is complete response (CR; no vomiting and no rescue medication) during the delayed phase (24–120 hours after cisplatin treatment). The secondary endpoints include complete control (CC) (CR without significant nausea) and total control (CR without nausea) rates during the overall (0–120 hours), acute (0–24 hours), and delayed phases; CR rate during the overall and acute phases; time to treatment failure, degree of nausea and appetite during the overall phase; and adherence to intervention. Estimated study completion: April 30, 2022. Discussion: This is the first prospective, randomized, double-blinded, placebo-controlled confirmatory study evaluating the additive beneficial effect of rikkunshito on CINV. This study is ongoing and is currently recruiting. Trial registration: Identifier on Japan Registry of Clinical Trials (jRCT): jRCT1011190007, registered December 2, 2019, https://jrct.niph.go.jp/en-latest-detail/jRCT1011190007.