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

Ran Yu, Xuefeng Wu, Liqun Jia, Yanni Lou, Ran Yu, Xuefeng Wu, Liqun Jia, Yanni Lou

Abstract

Background: LC09 is composed with 5 kinds of traditional Chinese herbal medicines (Astragalus membranaceus, flowers carthami, lithospermum, geranium wilfordii, and radix angelicae) which are used in China and developed over several thousand years. Aim: To assess the effectiveness and safety of herbal compound LC09 on patients with capecitabine-associated hand-foot syndrome (HFS). Materials and Methods: In this randomized, double-blind, and parallel-controlled study, 156 patients that diagnosed with HFS were randomly assigned to a treatment group (n = 78) or control group (n = 78). Patients were evaluated every week by the National Cancer Institute (NCI) grade and Numerical Rating Scale (NRS) pain scores. The Dermatology Life Quality Index (DLQI) scale and Instrumental Activity of Daily Living (IADL) scale were used to assess the quality of life before the treatment, and at 1 week and after the treatment of 2 cycles. Results: At the baseline, no significant differences were observed between the 2 groups. After treatment, significant differences in NCI grade and NRS pain scores were observed between the 2 groups (P < .01). In addition, HFS effectiveness rate and pain alleviation rate were significantly higher in the treatment group compared with the control group (P < .01). Furthermore, the chemotherapy completion rate between 2 groups was significantly different (P = .002). In addition, no adverse reactions were observed in either LC09 or control group. Conclusion: LC09 can decrease NCI grade and significantly alleviate pain in HFS patients. Besides, it can also increase chemotherapy completion rate.

Trial registration: ClinicalTrials.gov NCT02794493.

Keywords: capecitabine; granular formulation; hand-foot syndrome; medicine; traditional Chinese.

Conflict of interest statement

Declaration of Conflicting Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Figures

Figure 1.
Figure 1.
High-performance liquid chromatography/photo diode array detection of LC09.
Figure 2.
Figure 2.
Inclusion and exclusion criteria.
Figure 3.
Figure 3.
Proportion of 3 NCI (National Cancer Institute) grades at baseline (week 0) and after treatment (2 cycles).
Figure 4.
Figure 4.
Variation of NRS (Numerical Rating Scale) pain score at baseline (week 0) and after treatment (2 cycles).

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