Evaluating Qigong as a Clinical Intervention for Cancer Survivors' Fatigue

Fatigue Clinical Trial

Official title: Testing the Effects of Qigong on a Multi-System Neuro-muscular- Immune Model of Vigor in Cancer Survivorship

Status Recruiting

Clinical Trial Summary

This study compares Qigong movement-based meditation exercise with a healthy living exercise-wellness course. There are two primary goals of this research:

1. Evaluate and compare physiological mechanisms underlying the two wellness-exercise interventions with the specific goal of understanding the physiology of Qigong.

Using a simple noninvasive EEG setup, the study will test some of the same brain mechanisms that have been found in mindfulness meditation.

The study will also investigate Qigong's effects on stress and heart signals and on inflammation in the immune system. A key hypothesis is that Qigong will show distinctive, stronger effects on brain and heart measures. A related hypothesis is that Qigong will show stronger effects on blood markers of inflammation.

2. Compare effect sizes of the two interventions in decreasing fatigue in order to plan for a larger clinical trial.

Clinical Trial Description

Between 20-50% of Cancer Survivors report fatigue following treatment that interferes with their daily life. However, to date no treatment option has been definitively validated as effective for fatigue in survivors. In recent years Mind Body exercises such as yoga, Tai Chi, and Qigong have been shown in small clinical trials to be effective at treating the symptoms of CRF in a wide array of Cancer types. But understanding of basic science mechanisms is poor.

Recent studies of Mindfulness meditation, by the investigators and others, confirm the importance of brain mechanisms related to awareness and attention. This study will assess whether Qigong activates similar physiological processes. The study will also assess (1) whether emotion regulation improves, suggesting that Mindfulness-related processes may partially underlie changes in Qigong as a Mindful exercise (2) whether grip strength improves, suggesting that Qigong activates similar processes to conventional exercise.

As an exploratory question, the study will look at whether brain measures related to awareness are correlated with inflammatory markers called cytokines, suggesting possible neuro-immune interaction that may be relevant for understanding fatigue, vitality and embodied meditative movement therapies such as Qigong, Tai Chi and Yoga. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Fatigue

• NCT number: NCT02845492
• Study type: Interventional
• Source: The Miriam Hospital
• Contact: Chloe Zimmerman, BA
• Phone: 4018636272
• Email: chloe_zimmerman@brown.edu
• Status: Recruiting
• Phase: N/A
• Start date: July 2016
• Completion date: December 2017