Abstract
Background: Although tyrosine kinase inhibitors (TKIs) are still recommended as the standard therapy in renal cell carcinoma (RCC), the high frequency of adverse events is a weakness of this therapy. Because royal jelly (RJ) possesses anti-inflammatory and antioxidant properties, we assessed its protective effects on TKI-induced toxicities in RCC patients. Methods: We enrolled 33 patients with advanced RCC who were assigned to start TKI therapy in combination with a randomized, double-blinded, placebo-controlled RJ trial consisting of a placebo group with 17 subjects and an RJ group with 16 subjects. Results: Fatigue and anorexia frequencies in the RJ group were significantly lower than in the placebo group (p = 0.003 and 0.015, respectively). A statistically significant correlation between RJ and fatigue or anorexia was detected in sunitinib-treated patients. The dose reduction- or discontinuation-free periods were significantly longer (p = 0.013) in the RJ group than in the placebo group. Furthermore, similar observations were made in sunitinib-treated patients (p = 0.016). Conclusions: Our clinical trial showed that RJ exerted protective effects against TKI-induced fatigue and anorexia and lowered TKI dose reduction or discontinuation. Hence, RJ is beneficial for maintaining the quality of life and medication compliance in TKI-treated RCC patients.
Highlights
Renal cell carcinoma (RCC) is one of the most common urological cancers, and its incidence has continuously increased over the past few decades [1]
We investigated the preventive effects of prophylactic royal jelly (RJ) consumption on adverse events (AEs)
AEs associated with tyrosine kinase inhibitors (TKIs)-induced toxicities because the appropriate management of these AEs is critical for maintaining quality of life in renal cell carcinoma (RCC) patients treated with TKIs
Summary
Renal cell carcinoma (RCC) is one of the most common urological cancers, and its incidence has continuously increased over the past few decades [1]. New treatment options including immune check-point inhibitors are being developed; a molecularly targeted therapy using tyrosine kinase inhibitors (TKIs) is still the recommended standard therapy for these patients [2,3,4]. A major limitation of molecularly targeted therapies is the relatively high frequency of adverse events (AEs) with occasionally severe effects [9,10]. Tyrosine kinase inhibitors (TKIs) are still recommended as the standard therapy in renal cell carcinoma (RCC), the high frequency of adverse events is a weakness of this therapy. Results: Fatigue and anorexia frequencies in the RJ group were significantly lower than in the placebo group (p = 0.003 and 0.015, respectively). Conclusions: Our clinical trial showed that RJ exerted protective effects against
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