Effect of Yoga on Life Quality and Immunity in Breast Cancer Patients After Operation and or Chemotherapy

September 16, 2014 updated by: Shu-Hui Yeh, Chang Bing Show Chwan Memorial Hospital
The purpose of study is to investigate if yoga exercise improve life quality and immune status in breast cancer patients after complete treatment (including surgery and / or radiotherapy and / or chemotherapy)

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

It is well-known that exercise promote immune regulation for better life quality. However, the mechanism for better immunity and life quality is not clear. We postulate that Ayurveda yoga might benefit breast cancer women with completion of operation and/or chemotherapy and radiotherapy. The benefits could be due to immune modulation, and improve health perception and life quality, and even potential decrease of cancer relapse.

The study patients will do yoga twice a week for 12 weeks. The study primary endpoints are 1) to improve personal health perception, 2) to improve life quality and 3) to enhance human immunity. The study secondary endpoint will follow up the immunity changes 3 months after the intervention.

We anticipate to reach the primary endpoints and to publish the primary results in one year, the secondary endpoint will complete in the second year.

Study Type

Interventional

Enrollment (Anticipated)

40

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 Locations

  • Taiwan
      • Changhua County, Taiwan
        • Recruiting
        • Division of Core Laboratory; Chang Bing Show Chwan Memorial Hospital
        • Contact:

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Able to attend yoga program weekly, and fill out inform consent.
  • Patients with breast cancer after complete treatment for at least 3 months (including surgery and / or radiotherapy and/or chemotherapy).

Exclusion Criteria:

  • male
  • overweight
  • unable to do yoga exercise.

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: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Yoga exercise
Subjects will receive regular 90-minutes yoga classes twice a week for 3 months.
Behavioral: Yoga exercise
Subjects will receive regular 90-minutes yoga classes twice a week for 3 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improve personal health and life quality
Time Frame: Change from baseline in personal health and life quality at 6 months.
Health and life quality will assessed by modified fatigue inventory and EORTC QLQ-C30 (version 3) at three different times: (1)baseline data: before yoga exercise, (2)outcome data: at 6 and 12 weeks post-test.
Change from baseline in personal health and life quality at 6 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immune modulation
Time Frame: Change from baseline in human immunity at 3 months.
Lymphocytes will be extracted from peripheral blood for analyses of lymphocytes subpopulation (Th1/ Th2/ Treg/ Th17), polarization (T-bet/ Gata-3/ Foxp3/ RORrt) and its related cytokines (Th1: IL-12/ IFN-γ/ IL-27; Th2: IL-4/ IL-13/ IL-25; Th17: IL-17A/ IL-6/ IL-21; Treg: TGF/ IL-10. Saliva collection for analyses of cortisol and IL-6 at 3 different times: (1) baseline data: before yoga exercise, (2)outcome data: at 6 and 12 weeks post-test.
Change from baseline in human immunity at 3 months.

Collaborators and Investigators

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

Sponsor

Chang Bing Show Chwan Memorial Hospital

Investigators

  • Study Director: Kuender D. Yang, PhD, Chang Bing Show Chwan Memorial Hospital
  • Study Chair: Shu-Hui Yeh, PhD, Chang Bing Show Chwan Memorial Hospital & Central Taiwan University of Science and Technology
  • Principal Investigator: Shin-Mae Wang, MD., Show Chwan Memorial Hospital

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

May 1, 2014

Primary Completion (Anticipated)

April 1, 2015

Study Completion (Anticipated)

April 1, 2015

Study Registration Dates

First Submitted

September 16, 2014

First Submitted That Met QC Criteria

September 16, 2014

First Posted (Estimate)

September 17, 2014

Study Record Updates

Last Update Posted (Estimate)

September 17, 2014

Last Update Submitted That Met QC Criteria

September 16, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1020106

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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