Prophylactic TCM for Mitigation of EGFR-TKI Related Dermatological Adverse Effect
Status:
Completed
Trial end date:
2021-02-28
Target enrollment:
Participant gender:
Summary
Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) have become standard
practice for advanced non-small cell lung cancer (NSCLC) with EGFR gene mutation. EGFR-TKIs
involving Afatinib, Erlotinib, and Gefitinib were Food and Drug Administration (FDA) approved
since 2006 and given payment continuously for lung adenocarcinoma with EGFR mutation in
Taiwan.
Several researches mention the positive correlation between skin toxicities and clinical
response, such as improved median survival, overall survival and progression-free survival.
Nevertheless, quite a few patients reduced dose or discontinued EGFR-TKIs because of
prolonged or intolerable adverse effects, thus causing disease progress and even death. Based
on the experts' opinion, some basic strategies have been developed to manage dermatologic
adverse effects. Those strategies have the potential to improve patient quality of life and
to prevent dose reductions or discontinuation.
The concept of prophylaxis in EGFR-TKI related adverse effects had existed for rash and
diarrhea, but it is not well spread. Although several studies indicate that Traditional
Chinese Medicine (TCM) facilitates the treatment of lung cancer, clinical analysis of
prophylactic TCM in EGFR-TKIs related skin toxicities remains absent. Based on TCM syndrome
differentiation and treatment and clinical experiences, the investigators have found
effective TCM compositions to relieve these toxicities.
Therefore, the investigators develop a pilot, prospective, double-blinded, randomized
controlled TCM research to prevent EGFR- TKIs related dermatological adverse effects. The
purpose of this study suggest that TCM could provide synergic effect with EGFR-TKIs, which
means TCM could reduce and prevent EGFR-TKIs related dermatological adverse effects without
interfering formulary cancer therapy. The investigators hypothesize that prophylactic TCM
with standard of care will delay any grade skin toxicity to 14 days as well as reduce the
incidence of grade 3 skin toxicity from 30% to less than 10%.
Due to high EGFR mutation rate of lung adenocarcinoma in Taiwan, it is necessary to
investigate whether combination of TCM is beneficial to patients of advanced lung
adenocarcinoma with EGFR gene mutation.