The Effect of Physical Activity and Abstain From Smoking on the Precancerous Lesion

NCT ID: NCT03093623

Last Updated: 2017-04-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 446 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2017-12-31

Brief Summary

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

Detailed 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

Conditions

Cancer Cervix Uterus; Precancerous Lesions; Smoking

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Physical activity

In physical activity experimental group, trained study nurses will interview with patients,give health education,teach how to use and record the Activity meter.Professionals will calculate Metabolic Equivalent of Task(MET) with formula weekly.MET = (intensity level 9 points \* time of each exercise (hours) \* Number of times per week + moderate level 5 points \* time per activity (hours) \* number of times per week + low level 3 points \* time per activity (hours) \* number of times per week),investigators hope patients in the first month MET can reach (3.75-7.49 MET-h/ week), and reach moderate or more than moderate activity (\>= 7.5-16.49 MET-h/ week) at the starting of second month for at least one year.

Group Type: EXPERIMENTAL

Physical activity

Intervention Type: BEHAVIORAL

In physical activity experimental group, trained study nurses will interview with patients,give health education,teach how to use and record the Activity meter.Professionals will calculate Metabolic Equivalent of Task(MET) with formula weekly.MET = (intensity level 9 points \* time of each exercise (hours) \* Number of times per week + moderate level 5 points \* time per activity (hours) \* number of times per week + low level 3 points \* time per activity (hours) \* number of times per week),investigators hope patients in the first month MET can reach (3.75-7.49 MET-h/ week), and reach moderate or more than moderate activity (\>= 7.5-16.49 MET-h/ week) at the starting of second month for at least one year.

Non-Physical activity

the non-physical activity group,investigators do not give them any physical interventions

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Physical activity

In physical activity experimental group, trained study nurses will interview with patients,give health education,teach how to use and record the Activity meter.Professionals will calculate Metabolic Equivalent of Task(MET) with formula weekly.MET = (intensity level 9 points \* time of each exercise (hours) \* Number of times per week + moderate level 5 points \* time per activity (hours) \* number of times per week + low level 3 points \* time per activity (hours) \* number of times per week),investigators hope patients in the first month MET can reach (3.75-7.49 MET-h/ week), and reach moderate or more than moderate activity (\>= 7.5-16.49 MET-h/ week) at the starting of second month for at least one year.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Patients with precancerous neoplasia
• between 20 to 70 years

Exclusion Criteria

• Patients with server heart disease or other cancer.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Taipei Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hsiu-Ting Tsai, Phd

Role: PRINCIPAL_INVESTIGATOR

Taipei Medical University

Locations

Taipei Medical University

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Yu-Wen Su, Bs

Role: CONTACT

m432104011@tmu.edu.tw

0917562397

Hsiu-Ting Tsai, Phd

Role: CONTACT

hsiuting@tmu.edu.tw

02-2736-1661 ext. 6337

Facility Contacts

Wen-Chi Liu, MSc

Role: primary

116085@tmuh.org.tw

02-227372181 ext. 1300

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Other Identifiers

TMU-JIRB:201410013

Identifier Type: -

Identifier Source: org_study_id