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

Sponsor
Chang Bing Show Chwan Memorial Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02243163
Collaborator
(none)
40
1
1
11
3.6

Study Details

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)

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Yoga exercise
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Effect of Yoga on Life Quality and Immunity in Breast Cancer Patients After Operation and or Chemotherapy
Study Start Date :
May 1, 2014
Anticipated Primary Completion Date :
Apr 1, 2015
Anticipated Study Completion Date :
Apr 1, 2015

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Improve personal health and life quality [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.

Secondary Outcome Measures

  1. Immune modulation [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 65 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Division of Core Laboratory; Chang Bing Show Chwan Memorial Hospital Changhua County Taiwan

Sponsors and Collaborators

  • Chang Bing Show Chwan Memorial Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shu-Hui Yeh, RN, PhD, Professor, Chang Bing Show Chwan Memorial Hospital
ClinicalTrials.gov Identifier:
NCT02243163
Other Study ID Numbers:
  • 1020106
First Posted:
Sep 17, 2014
Last Update Posted:
Sep 17, 2014
Last Verified:
Sep 1, 2014
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 17, 2014