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

NCT03093623 | Unknown DMC

• 1 other identifier: TMU-JIRB:201410013
• Study Type: interventional
• Target: 446
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cancer Cervix Uterus; Precancerous Lesions; Smoking

Keywords

physical activity; abstain from smoking; human papillomavirus (HPV); cervical intraepithelial neoplasia (CIN)

Outcome Measures

Primary Outcomes (1)

• The effect of physical activity and abstain from smoking on the regression of precancerous

  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

Study Arms (2)

Physical activity

EXPERIMENTAL

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

Non-Physical activity

NO INTERVENTION

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

Interventions

Physical activity 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.

Physical activity

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with precancerous neoplasia
• between 20 to 70 years

You may not qualify if:

• Patients with server heart disease or other cancer.

Sponsors & Collaborators

• Taipei Medical University: lead

Study Sites (1)

Taipei Medical University

Taipei, 110, Taiwan

RECRUITING

Related Publications (69)

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MeSH Terms

Conditions

Smoking; Motor Activity; Uterine Cervical Dysplasia

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior; Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Hsiu-Ting Tsai, Phd

  Taipei Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu-Wen Su, Bs

CONTACT

0917562397; m432104011@tmu.edu.tw

Hsiu-Ting Tsai, Phd

CONTACT

02-2736-1661; hsiuting@tmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2017
• First Posted: March 28, 2017
• Study Start: October 1, 2014
• Primary Completion: October 1, 2017
• Study Completion: December 1, 2017
• Last Updated: April 11, 2017

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)