Survey on Chinese Medicine Syndrome for Patients With Non Small Cell Lung Cancer
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Purpose
Lung cancer has been the leading cancer worldwide, which 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 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. Current studies 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.
This study aims to investigate the distribution of TCM syndromes, the changing pattern among NSCLC patients before and after having surgery, chemotherapy and radiation therapy, and the correlations with patient quality of life and progression free survival. The results are important for establishing guidelines for TCM practice and research in future.
| Condition |
|---|
|
Lung Cancer |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | The Changing Pattern of Chinese Medicine Syndrome for Patients With Non Small Cell Lung Cancer in Hong Kong: A Longitudinal Survey |
- Changes of TCM syndromes [ Time Frame: Baseline (Pre-operation) and 1 week (Post-operation) ] [ Designated as safety issue: No ]
- Changes of TCM syndromes [ Time Frame: Baseline, Post chemotheray/radiation therapy, 3rd month, 6th month, 9th month, 12th month, 15th month, 18th month, 21month, 24month ] [ Designated as safety issue: No ]
- QoL assessment [ Time Frame: Post operation therapy, Post chemotheray/radiation therapy, 3rd month, 6th month, 9th month, 12th month, 15th month, 18th month, 21month, 24month ] [ Designated as safety issue: No ]using validated QLQ-C30 and QLQ-LC13 (Cantonese Hong Kong version)
- Progression free survival [ Time Frame: 3rd month, 6th month, 9th month, 12th month, 15th month, 18th month, 21th month, 24th month ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 225 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | June 2015 |
| Estimated Primary Completion Date: | June 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| NSCL cancer patients |
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
All newly suspected or diagnosed NSCLC patients from Department of Cardiothoracic Surgery who are going to have resection will be invited to participate in this study. Two interviews will be provided: pre- and post-operations in In-patient and Out-patient Departments of Cardiothoracic Surgery, respectively, for investigating the changing of TCM syndromes of individual patients, and its correlation with quality of life. Patients who are eligible for the study will be continuously followed for two years if their diagnoses of NSCLC are confirmed by postoperative pathological evaluation.
Inclusion criteria:
- newly suspected / diagnosed NSCLC patients from Department of Cardiothoracic Surgery and going to have resection
- age of 18 or above
- without prior therapy for NSCLC, including surgery, chemotherapy, radiation therapy and Chinese herbal medicine
- patients who can read and speak Chinese
Exclusion criteria:
- history of prior therapy for NSCLC
- history of concurrent or prior malignancy
- with concurrent open tuberculosis or inflection
- unable to communicate (e.g. cognitive impairment)
- psychiatric or addictive disorders
Contacts and Locations| China | |
| Queen Elizabeth Hospital | Recruiting |
| Hong Kong, China | |
| Contact: Hollie CW Cheng, Mphil (852) 2958 7847 hollie_cheng@yahoo.com.hk | |
| Contact: Peter PF So, MD (852) 2958 2307 spfz01@ha.org.hk | |
| Principal Investigator: Peter PF So, MD | |
| Principal Investigator: | Peter PF So, MD | Queen Elizabeth Hospital |
More Information
No publications provided
| Responsible Party: | ZhaoXiang Bian, Professor, Hong Kong Baptist University |
| ClinicalTrials.gov Identifier: | NCT01681485 History of Changes |
| Other Study ID Numbers: | KCC(QEH)/HKBU/NSCLC2012 |
| Study First Received: | June 12, 2012 |
| Last Updated: | September 5, 2012 |
| Health Authority: | Hong Kong: Ethics Committee |
Keywords provided by Hong Kong Baptist University:
|
Traditional Chinese medicine Non small cell lung cancer Surgery Chemotherapy Radiation therapy |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms |
Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 22, 2013