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Medicines (Basel). 2018 Dec 20;6(1). pii: E2. doi: 10.3390/medicines6010002.

Oral Intake of Royal Jelly Has Protective Effects Against Tyrosine Kinase Inhibitor-Induced Toxicity in Patients with Renal Cell Carcinoma: A Randomized, Double-Blinded, Placebo-Controlled Trial.

Author information

1
Department of Urology, Nagasaki University Graduate School of Biomedical Sciences, 1-7-1 Sakamoto, Nagasaki, Nagasaki 852-8501, Japan. k-araki205@cameo.plala.or.jp.
2
Department of Urology, Nagasaki University Graduate School of Biomedical Sciences, 1-7-1 Sakamoto, Nagasaki, Nagasaki 852-8501, Japan. yasu-myt@nagasaki-u.ac.jp.
3
Department of Urology, Nagasaki University Graduate School of Biomedical Sciences, 1-7-1 Sakamoto, Nagasaki, Nagasaki 852-8501, Japan. ohba-k@nagasaki-u.ac.jp.
4
Department of Urology, Nagasaki University Graduate School of Biomedical Sciences, 1-7-1 Sakamoto, Nagasaki, Nagasaki 852-8501, Japan. yn1238056@yahoo.co.jp.
5
Department of Urology, Nagasaki University Graduate School of Biomedical Sciences, 1-7-1 Sakamoto, Nagasaki, Nagasaki 852-8501, Japan. tomozo1228@hotmail.com.
6
Department of Urology, Nagasaki University Graduate School of Biomedical Sciences, 1-7-1 Sakamoto, Nagasaki, Nagasaki 852-8501, Japan. mochi@nagasaki-u.ac.jp.
7
Department of Urology, Nagasaki University Graduate School of Biomedical Sciences, 1-7-1 Sakamoto, Nagasaki, Nagasaki 852-8501, Japan. hsakai@nagasaki-u.ac.jp.

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.

KEYWORDS:

adverse events; double-blinded; randomized clinical trial; renal cell carcinoma; royal jelly; tyrosine kinase inhibitors

PMID:
30577515
DOI:
10.3390/medicines6010002
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