Survey on Chinese Medicine Syndrome for Patients With Non Small Cell Lung Cancer

NCT01681485 | Terminated DMC

• 1 other identifier: KCC(QEH)/HKBU/NSCLC2012
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Cancer

Keywords

Traditional Chinese medicine; Non small cell lung cancer; Surgery; Chemotherapy; Radiation therapy

Outcome Measures

Primary Outcomes (1)

• Changes of TCM syndromes

  Baseline (Pre-operation) and 1 week (Post-operation)

Secondary Outcomes (3)

• Changes of TCM syndromes

  Baseline, Post chemotheray/radiation therapy, 3rd month, 6th month, 9th month, 12th month, 15th month, 18th month, 21month, 24month

• QoL assessment

  Post operation therapy, Post chemotheray/radiation therapy, 3rd month, 6th month, 9th month, 12th month, 15th month, 18th month, 21month, 24month

• Progression free survival

  3rd month, 6th month, 9th month, 12th month, 15th month, 18th month, 21th month, 24th month

Study Arms (1)

NSCL cancer patients

Surgery, chemotherapy and/or radiation therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hong Kong Baptist University: lead
• The Queen Elizabeth Hospital: collaborator

Study Sites (1)

Queen Elizabeth Hospital

Hong Kong, China

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Study Officials

• Peter PF So, MD

  The Queen Elizabeth Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 12, 2012
• First Posted: September 10, 2012
• Study Start: June 1, 2012
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: August 4, 2015

Record last verified: 2015-07

Locations

CN (1)