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

Not Applicable

• Conditions: Female Breast Carcinoma
• Interventions: Behavioral: Yoga exercise

• Registration Number: NCT02243163
• Lead Sponsor: Chang Bing Show Chwan Memorial Hospital

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.

Study Timeline

• Study Start: 2014-05
• Status Verified: 2014-09
• Study First Submitted: 2014-09-16
• Study First Submitted QC: 2014-09-16
• Last Update Submitted: 2014-09-16
• Study First Posted: 2014-09-17
• Last Update Posted: 2014-09-17
• Primary Completion: 2015-04
• Study Completion: 2015-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Yoga exercise	Yoga exercise	Subjects will receive regular 90-minutes yoga classes twice a week for 3 months.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Division of Core Laboratory; Chang Bing Show Chwan Memorial Hospital; 🇨🇳 Changhua County, Taiwan