Qigong / Tai Chi Easy for fatigue in breast cancer survivors: Rationale and design of a randomized clinical trial.

Author: Larkey L1, Huberty J1, Pedersen M2, Weihs K1
Affiliation: <sup>1</sup>Arizona State University, School of Nutrition and Health Promotion, ASU PANW Program, Phoenix, AZ 85004, United States. <sup>2</sup>Arizona State University, School of Nutrition and Health Promotion, ASU PANW Program, Phoenix, AZ 85004, United States. Electronic address: pedersen.maja@gmail.com.
Conference/Journal: Contemp Clin Trials.
Date published: 2016 Aug 16
Other: Pages: S1551-7144(16)30200-2 , Special Notes: doi: 10.1016/j.cct.2016.08.002. [Epub ahead of print] , Word Count: 274


INTRODUCTION: Breast cancer survivors (BCSs) often report fatigue that persists for years following treatment. Despite a growing body of evidence for meditative movement practices to improve symptoms among BCSs, few studies have explored using Qigong/Tai Chi to reduce fatigue. Additionally, few have examined the biological mechanisms through which fatigue may be reduced using Qigong/Tai Chi.

METHODS/STUDY DESIGN: We will recruit 250 fatigued, post-menopausal women diagnosed with breast cancer (stage 0-III), between 6 months and 5 years past primary treatment and randomize to a standardized Qigong/Tai Chi Easy (QG/TCE) intervention, a "sham" Qigong group (movements without a focus on the breath and meditative state) (SQG), or an educational support (ES) group. The primary outcome (fatigue), secondary outcomes (anxiety, depression, sleep quality, cognitive function, physical activity), and a biomarker of HPA axis dysregulation (diurnal cortisol) will be assessed at baseline, post-intervention and 6 months postintervention, and biomarkers of inflammation (IL1ra, IL6, TNFα and INFᵧ) at pre/post-intervention. We hypothesize that QG/TCE will reduce fatigue (and improve other symptoms associated with fatigue) in BCSs experiencing persistent cancer-related fatigue more than SQG and ES. Biomarkers will be examined for relationships to changes in fatigue.

CONCLUSIONS: Findings from this study may reveal the effects of the unique mind-body aspects of QG/TCE on fatigue in BCSs with a complex design that separates the effects of low-intensity physical activity (SQG) and social support/attention (ES) from the primary intervention. Further, results will likely contribute greater understanding of the biological mechanisms of these practices related to improved symptoms among BCSs.

Copyright © 2016. Published by Elsevier Inc.

KEYWORDS: Breast neoplasm; Fatigue; Qigong; Survivor symptoms; Tai Chi

PMID: 27543065 DOI: 10.1016/j.cct.2016.08.002