Prophylactic TCM for Mitigation of EGFR-TKI Related Dermatological Adverse Effect

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-12

Study Completion Date

2021-02-28

Brief Summary

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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.

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Detailed Description

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Lung cancer is the leading cause of cancer deaths worldwide. According to National Comprehensive Cancer Network (NCCN) Guidelines, EGFR-TKIs have become standard practice for advanced NSCLC with EGFR gene mutation. An epidemiological study in 2012 reported that EGFR mutations from Asian advanced lung adenocarcinoma patients were 22-64% and the rate in Taiwan was 62.1%. Another epidemiological study in 2015 showed that the EGFR mutation rate of treatment -naïve lung adenocarcinoma in Taiwan was 55.4%.

Depend on several extensive studies, oral treatment of EGFR-TKIs improved progression free survival (PFS) about 9.2-13.6% than traditional chemotherapy. EGFR-TKIs involving Afatinib, Erlotinib, and Gefitinib were 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 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.

Conditions

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Advanced Lung Adenocarcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Study arm

Patients receive afatinib and TCM. TCM recipe was chosen from three essential TCM formulas, including Bai He Gu Jin Tang (yin nourishing), Wen Dan Tang (phlegm reducing), and Qing Shang Fang Fen Tang (heat clearing). The packages contained 1.6 g TCM preparations, which were manufactured in powder form by Sun Ten Pharmaceutical (Taichung, Taiwan) according to the good manufacturing practice requirements. Patients were instructed to intake three packages of TCM preparations with each meal three times a day, for a total of nine packages per day. Administration of TCM was initiated at the same time as afatinib and continued for a total of three months.

Group Type EXPERIMENTAL

TCM Formula

Intervention Type DRUG

three packages of TCM preparations with each meal three times a day

Control arm

Patients receive afatinib and placebo. Placebo without the medical ingredients was prepared to be similar to the weight, color, smell, taste, and packaging of the TCM formulas. The packages contained 1.6 g placebo preparations, which were manufactured in powder form by Sun Ten Pharmaceutical (Taichung, Taiwan) according to the good manufacturing practice requirements. Patients were instructed to intake three packages of placebo preparations with each meal three times a day, for a total of nine packages per day. Administration of placebo was initiated at the same time as afatinib and continued for a total of three months.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

three packages of placebo preparations with each meal three times a day

Interventions

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TCM Formula

three packages of TCM preparations with each meal three times a day

Intervention Type DRUG

Placebo

three packages of placebo preparations with each meal three times a day

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Patients with histologically confirmed diagnosis of locally advanced or metastatic lung adenocarcinoma with EGFR mutations,
2. Patients with an Eastern Cooperative Oncology Group performance status score of 0-2,
3. Patients receiving afatinib as first-line treatment to ensure a shorter time to observe skin adverse effects of any grade,
4. Patients with measurable disease evaluated by the Response Evaluation Criteria in Solid Tumors (version 1.1),
5. Patients with brain metastases were included after adequate treatment.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No