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Clinical Trial Summary

In this proposed project,investigators will estimate the effect of physical activity and abstain from smoking on the regression of precancerous neoplasia.


Clinical Trial Description

Cervical cancer is the seventh most common malignancy and the sixth most common cause of cancer-related death in Taiwan. The development of cervical cancer is passed through cervical intraepithelial neoplasia (CIN), including CIN I, CIN II, and CIN III. CIN I is classified as low-grade squamous intraepithelial lesion (LSIL), and about 57% of patients with CIN I are known to regress spontaneously, while patients with CIN II or CIN III is 5% and 15% to progress to invasive cervical cancer, respectively. Both two need active treatment and are classified as high-grade squamous intraepithelial lesion (HSIL). Fortunately, the 5-year survival rate is more than 90% for patients with CINs if they receive clinical management as soon as possible. The immunocompetence plays an important role for prevention of cervical cancer. High-risk human papillomavirus (HR-HPV) infection is demonstrated as one of the vital risk factors of CIN and cervical cancer. Most HPV infection is known to regress spontaneously by cell-mediated immunity, whereas a small fraction persistant HPV infection, which increase the risk of CIN and promote the progression to cervical cancer. Physical activity is reported to increase the cell number and activity of immune cells and promote cell-mediated cytotoxic effect to protect against HPV and cancer cells. Also, it is found that physical activity decrease the risk of breast cancer, hepatocellular carcinoma, colon cancer, and prostate cancer. Regular moderate intensity physical activity is ssociated with a decrease in the death from cancer. Moreover, tobacco smoke is reported to abate human immunocompetence and raise the risk of cervical cancer as well as to enhance the progression of CIN through the inhibition of cell-mediated immunity. Also, the extract of tobacco is demonstrated to enhance the proliferation and viral load of HPV, consequently induce carcinogenesis of cervical intraepithelial cells. Investigators suggest that physical activity could decrease the risk of CIN through promote cell-mediated immunity. Also, physical activity and abstain from smoking could be benefit to the regression of CIN and the decreasing of DNA viral load of HPV. However, the roles of physical activity and abstain from smoking on the regression of CIN and viral load are not fully clarified. Therefore, in this proposed project, investigators will 【1】estimate the effect of physical activity on decreasing the risk of cervical intraepithelial neoplasia. 【2】estimate the effect of physical activity on the regression of cervical intraepithelial neoplasia. 【3】estimate the effect of abstain from smoking on the regression of cervical intraepithelial neoplasia. 【4】estimate the additive effect and synergistic effect of physical activity and abstain from smoking on the regression of cervical intraepithelial neoplasia. 【5】estimate the effect of physical activity on the decreasing of DNA viral load of human papillomavirus. 【6】estimate the effect of abstain from smoking on the decreasing of DNA viral load of human papillomavirus. 【7】estimate the additive effect and synergistic effect of physical activity and abstain from smoking on the decreasing of DNA viral load of human papillomavirus ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03093623
Study type Interventional
Source Taipei Medical University
Contact Yu-Wen Su, Bs
Phone 0917562397
Email m432104011@tmu.edu.tw
Status Recruiting
Phase N/A
Start date October 2014
Completion date December 2017

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