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

Female Breast Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02243163
• Other study ID #: 1020106
• Status: Recruiting
• Phase: N/A
• First received: September 16, 2014
• Last updated: September 16, 2014
• Start date: May 2014
• Est. completion date: April 2015

Study information

• Verified date: September 2014
• Source: Chang Bing Show Chwan Memorial Hospital
• Contact: Shin-Mae Wang, MD.
• Email: wangznmg[@]gmail.com
• Is FDA regulated: No
• Health authority: Taiwan: Ministry of Health and Welfare
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 65 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Breast Neoplasms
• Carcinoma
• Female Breast Carcinoma

Intervention

Behavioral:
• Yoga exercise
Subjects will receive regular 90-minutes yoga classes twice a week for 3 months.

Locations

Country	Name	City	State
Taiwan	Division of Core Laboratory; Chang Bing Show Chwan Memorial Hospital	Changhua County

Sponsors (1)

Lead Sponsor	Collaborator
Chang Bing Show Chwan Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from baseline in personal health and life quality at 6 months.	No
Secondary	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-?/ 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.	No