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

April 9, 2017 updated by: Taipei Medical University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

446

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
      • Taipei, Taiwan, 110
        • Recruiting
        • Taipei Medical University
        • Contact:
        • Principal Investigator:
          • Hsiu-Ting Tsai, Phd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients with precancerous neoplasia
  • between 20 to 70 years

Exclusion Criteria:

  • Patients with server heart disease or other cancer.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Behavioral: 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.
NO_INTERVENTION: Non-Physical activity
the non-physical activity group,investigators do not give them any physical interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The effect of physical activity and abstain from smoking on the regression of precancerous
Time Frame: 2 years

To estimate the effect of moderate physical activity and abstain from smoking can strengthen the innate immune system,adaptive human immune system and can help regression of Cervical intraepithelial neoplasia among patients with cervical cancer.

Using a composite outcome measure consisting of questionnaire,blood counts,plasma and DNA.

blood counts :white blood cells,hemoglobin,red blood cells,platelets,Neutrophil,Lymphocyte,Monocyte,Eosinophil,Basophil,CD-4,CD-8,NK-cell,B-cell.

plasma:lL-1,IL-2,IL-4,IL-5,IL,6,LI-8,IL-10,IL-13,TNF-r
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Medical University

Investigators

  • Principal Investigator: Hsiu-Ting Tsai, Phd, Taipei Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (ANTICIPATED)

October 1, 2017

Study Completion (ANTICIPATED)

December 1, 2017

Study Registration Dates

First Submitted

March 23, 2017

First Submitted That Met QC Criteria

March 23, 2017

First Posted (ACTUAL)

March 28, 2017

Study Record Updates

Last Update Posted (ACTUAL)

April 11, 2017

Last Update Submitted That Met QC Criteria

April 9, 2017

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TMU-JIRB:201410013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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