3913 - Effect of Chinese Herbal Compound LC09 on Patients With Capecitabine-Associated Hand-Foot Syndrome: A Randomized, Double-Blind, Placebo-Controlled Trial

Background

Hand-foot syndrome (HFS) is an adverse effect which triggered by chemotherapy, Capecitabine has the highest reported HFS incidence at about 50% to 60%. LC09 is composed of Chinese herbs and is used to soak hands and feet. Former clinical study and animal experiment have shown that Chinese herbal compound LC09 can alleviate numb, pain and inflammation. This study is aimed to evaluate its validity via strictly randomized, double-blind, placebo-controlled trial.

Methods

156 patients which is diagnosed as HFS randomly assigned 1:1 to treatment group (n = 78) and control group (n = 78) in 4 centers. Intervention of LC09 or placebo is lasting for 6 weeks and evaluated every week by NCI degree, NRS pain scores. Assess quality of life using DLQI (dermatology life quality index) scale and IADL (instrumental activity of daily living) scale at the beginning one week later and the end.

Results

NCI degree and NRS pain scores between two groups are significant difference (p < 0.001). HFS effective rate (70.4%) and pain alleviated rate (81.9%) of treatment group are significantly higher than control group (p < 0.001). There is no intense evidence identify the effect for quality of life with LC09 after assessing by DLQI scale and IADL scale. Chemical completion rate between two groups is significantly different, P = 0.0021.

Conclusions

Chinese herbal compound LC09 can decrease NCI degree and alleviate pain significantly. Besides, it can also increase chemical completion rate. But effect for quality of life still needs to search with more specific scale.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Ministry of Science and Technology of the People’s Republic of China (2015BAI04B07).

Disclosure

All authors have declared no conflicts of interest.