Randomized, Double blind, Placebo Controlled Clinical Study of Chinese Herbal Formula JDXZO Cream to Reduce Skin Lesion Associated with EGFRIs Therapy
Hongsheng Lin1, Changhuai Chen2, Qian Dong 1
Keywords: epidermal growth factor receptor inhibitor (EGFRI), skin lesion, herbal formula, cream
Purpose: Skin lesion associated with epidermal growth factor receptor inhibitor (EGFRI) therapy is a common side effect. It is generally considered mild to moderate and affects more than 50% of patients receiving treatment showed in literatures. The incidence of severe rash (grade 3) is reported in up to 16% to 18% of patients. If patients have severe skin lesion that doctors had to reduce their dose or stop EFGRI therapy. Chinese herbal medicine JDXZF is an empirical formula. JDXZO is an advanced Chinese herbal extract cream based on JDXZF for easy use. The previous study has shown JDXZO is effective for the skin lesion on treating HFS caused by 5-Fu and its derivatives and has no side effect. This randomized, double blind, placebo-controlled study is to evaluate the safety and efficacy of JDXZO for skin lesion caused by EGFRIs.
Methods: Cancer patients with skin toxicity grade >= 1 (NCI-CTCAE version 3.0) caused by EGFRIs were eligible. Patients with same skin toxicity grade level were randomized to cream A or cream B arm and instructed to gently apply cream on affected areas twice daily for four weeks. Patients were assessed on baseline and on treatment of two and four weeks. Evaluation criteria: CR as symptoms disappear completely, PR as grade decreases more than one level, NR as symptoms or grade has no change or increase, total response rate as CR + PR. Time to grade level decrease was counted in days for each symptoms.
Results: 59 cases in effect were evaluated. Patients in cream A or B arm were 31 and 28. All of these patients have skin rash and itching, part of them have desquamation, cracking and pigmentation. Only a few patients have paronychia and pain. There was no statistical difference between the two arms in gender, age, types of drug and grad of skin lesion (P>0.05). In cream A arm, the total response rate of skin rash was 70.96% on treatment of two weeks and 80.65% of four weeks, and those of cream B arm were 28.57%(P<0.001) and 35.71%(P<0.001), respectively. The total response rate of itching in cream A arm was 74.19% on treatment of two weeks and 87.10% of four weeks, better than those of cream B arm which were 39.29% (P<0.05) and 46.43%(P<0.001). The total response of desquamation of week 2 is 75% in arm A and 44% in arm B (P>0.05), while on week four, it was 89.29% in arm A, better than that of arm B 48% (P<0.05). Symptoms of pigmentation and cracking were all improved in the two arms but had no significance between them although the total response in cream A arm seems higher. There were 3 cases of paronychia and 5 cases with pain appeared in cream A arm and were all relieved during therapy. 2 cases of paronychia and 3 case of pain in cream B arm had not been relieved. The average treatment time for grade level decrease of each symptom in cream A arm was much shorter (P<0.001) than that of cream B arm, especially among symptoms of itching, desquamation and rash with the average time of 4.97, 5.21 and 6.39 days. After the experiment ended, the data was analyzed and unblinded. Cream A was JDXZO and Cream B was placebo. There was no side effect found in both arms.
Conclusion: JDXZO was superior to placebo in improving skin lesion caused by EGFRIs. Cream A and Cream B were provided by Unitech Medical® in this study.
Footnotes: This abstract was selected for oral presentation at the Ninth International Conference of the Society for Integrative Oncology in October 2012. The formulation of CamWell™ Hand to Heal™ cream is the same as Cream B above in this randomized, double blind, placebo controlled clinical study. 1. Dept of Oncology, Guang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China. 2. Puxiang TCM Cancer Hospital, Beijing, China.