Trial Information

The Changing Pattern of Chinese Medicine Syndrome for Patients With Non Small Cell Lung Cancer in Hong Kong: A Longitudinal Survey

Lung cancer has been the leading cancer worldwide since 1985 both in terms of incidence and
mortality. According to the GLOBOCAN project of World Health Organization (WHO), there were
about 1.6 million new cases (12.7% of the total) and 1.4 million deaths (18.2% of the total)
in 2008 globally. Although the prevalence rates have already been decreasing in males, there
are increasing trends in females and less developed countries. From the data of Hong Kong
Cancer Registry for 2009, there were 4,365 new cases and 3,692 deaths, representing 16.8%
and 28.8% of all cancers, respectively.

Lung cancer can be divided into small cell lung cancer (SCLC) and non-small cell lung cancer
(NSCLC) based on biology, therapy, and prognosis. NSCLC accounts for more than 85% of all
lung cancer cases and includes two major types: squamous cell (epidermoid) carcinoma and
nonsquamous carcinoma (including adenocarcinoma, large-cell carcinoma and other cell types).
Conventional treatment modalities for patients with NSCLC include surgery, radiation therapy
and chemotherapy. Surgery is the most potentially curative therapeutic option, while
postoperative chemotherapy may provide an additional benefit. However, NSCLC is frequently
diagnosed at an advanced stage and not suitable for surgery. Chemotherapy has produced
short-term improvement in disease-related symptoms, and offers modest improvements in median
survival in patients with advanced-stage disease. Radiation therapy combined with
chemotherapy can produce a cure in a small number of patients and palliation in most others.
Generally, NSCLC has a poor prognosis with only 15% of all lung cancer patients alive 5
years or more after diagnosis.

Traditional Chinese medicine (TCM) originated from Chinese philosophy is a different medical
system from conventional western medicine. It focuses on health maintenance and emphasizes
on harmonizing the imbalance of body. Related records about cancer can first be found in
Yellow Emperor's Inner Classic compiled between 200 B.C. and 100 A.D. Nowadays, TCM is
increasingly used as an adjunctive treatment for cancer patients. According to the survey
carried by the Hong Kong Baptist University and Queen Elizabeth Hospital in 2008, over half
of all cancer patients had received at least one form of TCM therapy. Current studies also
show that TCM has the advantages of increasing the sensitivity of chemo- and
radio-therapeutics, reducing the side effects and chemo- and radio-therapeutics associated
complications, improving patients' quality of life and survival time. However, how TCM can
work with conventional medicine for the treatment of carcinoma is still an important
research topic worldwide.

Syndrome, the essential concept in TCM theory, is a diagnostic conclusion of the
pathological changes at a certain stage of a disease, including the location, cause, and
nature as well as the trend of development. It is derived from all symptoms and signs
collected by the classic four diagnostic methods, including observation, smell/listening,
inquiry and palpation. However, there is no consensus on the definition of diagnosis of
syndromes for NSCLC as different diagnostic and treatment guidelines are published by TCM
experts, colleges and associations. In practice, TCM practitioners are used to make
diagnosis and provide treatment on the basis of their own experiences. Therefore, more
consolidated evidences are urged for standardizing the diagnosis and distribution of
syndrome for routine practice and research.

Apart from traditional syndrome studies, advance studies about the influence of conventional
treatments on syndromes, and the correlation between syndromes and conventional measures had
been done in the past decades. From the review summarizing the syndrome changes after
surgery, radiation therapy or chemotherapy, deficiency syndrome and blood stasis syndrome
are the fundamental syndrome patterns among cancer patients while tongue manifestation is
significant for early stage diagnosis, outcome assessment and prognosis. A number of studies
have analyzed the distribution of symptoms for NSCLC patients in different TNM stages, cell
types, and assessment indexes, including quality of life, immunological indexes and
hemorheology. However, most of them were cross-sectional epidemiological studies or with
short follow-up period. Therefore, the impact of these factors on syndromes cannot be
completely elucidated.

In this present longitudinal study, patients with new diagnosed NSCLC will be followed for
two years. During this period, the changing patterns of TCM syndromes for patients before
and after conventional treatment, including surgery, radiation therapy and chemotherapy will
be analyzed. Furthermore, the correlations between TCM syndromes and quality of life or
progress-free survival will also be investigated. We hope that the results from this study
can provide more consolidated evidences about the effects of conventional treatments on TCM
syndromes, for standardizing the diagnosis of TCM syndromes for NSCLC for clinical practice,
and promoting further research on integrated medicine for NSCLC.