search
Back to results

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

Primary Purpose

Female Breast Carcinoma

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Yoga exercise
Sponsored by
Chang Bing Show Chwan Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Female Breast Carcinoma

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Division of Core Laboratory; Chang Bing Show Chwan Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Yoga exercise

Arm Description

Subjects will receive regular 90-minutes yoga classes twice a week for 3 months.

Outcomes

Primary Outcome Measures

Improve personal health and life quality
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.

Secondary Outcome Measures

Immune modulation
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.

Full Information

First Posted
September 16, 2014
Last Updated
September 16, 2014
Sponsor
Chang Bing Show Chwan Memorial Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02243163
Brief Title
Effect of Yoga on Life Quality and Immunity in Breast Cancer Patients After Operation and or Chemotherapy
Official Title
Effect of Yoga on Life Quality and Immunity in Breast Cancer Patients After Operation and or Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (undefined)
Primary Completion Date
April 2015 (Anticipated)
Study Completion Date
April 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Bing Show Chwan Memorial Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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)
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Female Breast Carcinoma

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Yoga exercise
Arm Type
Experimental
Arm Description
Subjects will receive regular 90-minutes yoga classes twice a week for 3 months.
Intervention Type
Behavioral
Intervention Name(s)
Yoga exercise
Intervention Description
Subjects will receive regular 90-minutes yoga classes twice a week for 3 months.
Primary Outcome Measure Information:
Title
Improve personal health and life quality
Description
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.
Time Frame
Change from baseline in personal health and life quality at 6 months.
Secondary Outcome Measure Information:
Title
Immune modulation
Description
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.
Time Frame
Change from baseline in human immunity at 3 months.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shin-Mae Wang, MD.
Email
wangznmg@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Shu-Hui Yeh Yeh, PhD
Email
yehshuhui@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shu-Hui Yeh, PhD
Organizational Affiliation
Chang Bing Show Chwan Memorial Hospital & Central Taiwan University of Science and Technology
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Kuender D. Yang, PhD
Organizational Affiliation
Chang Bing Show Chwan Memorial Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Shin-Mae Wang, MD.
Organizational Affiliation
Show Chwan Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Core Laboratory; Chang Bing Show Chwan Memorial Hospital
City
Changhua County
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kuender D. Yang, PhD
Phone
886-975617006
Email
yangkd.yeh@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs