Study on Tong-Luo-San in treating hand-foot skin reaction induced by multikinase inhibitors: A randomized, placebo-controlled clinical trial

Background

Hand-foot skin reaction (HFSR) is the most common and most serious adverse event induced by multikinase inhibitors (MKIs). About 9%–62% patients receiving sorafenib or sunitinib treatments develop HFSR. Severe HFSR leads to dose reduction or suspension of MKI treatment.

Methods

Twenty-seven HFSR patients induced by sorafenib or sunitinib were included. SAS statistical software was used and patients were randomly divided into 2 groupx: experimental group (14 cases) and control group (13 cases). Tong-Luo-San (TLS) was locally administered for 7 days (20 min, bid), compared with placebo as blank control. Observation parameters included pain numerical rating scale (NRS) scores, HFSR grading of National Cancer Institute common terminology criteria for adverse events (NCI-CTCAE), clinical grading of National Comprehensive Cancer Network (NCCN) grade in Impact of Pain Measurement Scores, total effective rate, analgesic efficacy rate and adverse events.

Results

NRS scores, HFSR grade and NCCN grade in impact of pain measurement scores decreased obviously after 7 days' treatment in the experimental group (P 

Conclusions

TLS significantly reduced HFSR grade, alleviated pain and improved patients' quality of life. It was also safe and convenient to use.

Clinical trial identification

Legal entity responsible for the study

China-Japan Friendship Hospital

Funding

Ministry of Science and Technology of People's Republic of China

Disclosure

All authors have declared no conflicts of interest.