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.