Evaluating Qigong as a Clinical Intervention for Cancer Survivors' Fatigue

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

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.

Study Overview

• Status: Unknown
• Conditions: Fatigue
• Intervention / Treatment: Other: Qigong; Other: Complete Health Improvement Program (CHIP)

Detailed 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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chloe Zimmerman, BA; Phone Number: 4018636272; Email: chloe_zimmerman@brown.edu
• Study Contact Backup: Name: Brendan Cullen, BA; Phone Number: 4018636272; Email: Brendan_Cullen@brown.edu

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02904
      • Recruiting
      • Miriam Hospital
      • Contact: Chloe Zimmerman; Phone Number: 401-863-6272; Email: cancersurvivor@lifespan.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Female patients
• Aged 18-70 years
• Self-report of fatigue =/> 3/10 on fatigue interference scale
• Have been diagnosed and completed treatment for cancer (with surgery or radiation or chemotherapy)
• no surgery, radiation or chemotherapy received in the past 8 weeks (ongoing treatment with Herceptin [trastuzumab] or other adjuvant therapies is permitted)
• Currently cancer-free
• Have a primary care or other physician
• Ability to understand English
• Willingness to have blood drawn, have an EEG taken and complete questionnaires
• Ability to pass basic validated physical movement tests (e.g.: standing with feet touching for 30 seconds, twist right to left and back, hold arms out to side in air for 15 seconds, lift arms over head, moving from standing position to seated position on the floor) to verify safety for Qigong practice.

Exclusion Criteria:

• History or current diagnosis of medical or psychiatric disorder that would interfere with ability to participate in wellness classes or in scientific assessment sessions (e.g., rheumatoid arthritis, diabetes, major psychiatric disorder, connective tissue disorder)
• Body Mass Index (BMI) > 31
• Active alcohol or drug abuse
• Tobacco use
• Pregnancy
• Regular daily use of anti-inflammatory drugs, including non-steroidal anti-inflammatory drugs, (does not apply to common use of daily "baby aspirin" as daily prophylactic cardiovascular treatment)
• Resting systolic blood pressure of less than 90 or greater than 160 and resting diastolic blood pressure of greater than 110.
• Ingestion of caffeine or cocoa products less than two hours from data collection
• Contraindication to regular physical activity participation
• Already engaging in >60 min of vigorous physical activity per week for the prior month
• Weekly practice of yoga, Tai Chi, Qigong, or meditation since the diagnosis of cancer
• Peripheral neuropathy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Qigong intervention; Qigong meditative exercise intervention meets three times a week for 10 weeks. The qigong group (n=30) will meet at the Women's Medicine Collaborative, Miriam Hospital (146 W. River St., Providence, RI) for Qigong classes. The lesson will be taught by a validated Qi Gong master with over forty years of experience and the interventional protocol will be validated. Two and a half hours of weekly outside personal practice will also be required of participants.	Other: Qigong; Qigong is a mind-body exercise based around gentle exercise and the cultivation of a meditative focus on bodily sensations; Other Names: Meditative Exercise Therapy
ACTIVE_COMPARATOR: CHIP healthy wellness-exercise class; The Complete Health Improvement Program is a validated set of weekly classes designed to promote gentle exercise and wellness related activities in a supportive group setting led by an experienced trainer.	Other: Complete Health Improvement Program (CHIP); The CHIP program is a validated weekly wellness and exercise program designed to promote health and wellbeing.; Other Names: Wellness-Exercise Program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fatigue Symptom Inventory Questionnaire	Questions about daily experience of fatigue	Change from baseline to 10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EEG meditative brain measures,	Acquired using a non-invasive EEG cap that sits on the scalp	at baseline and at 10 weeks
Self-reported Vitality (a component of the Medical Outcomes Short-Form 36)		at baseline and 10 weeks
Heart Rate Variability (HRV)	Acquired using an EKG	at baseline and 10 weeks
Inflammatory cytokines	Cytokine measures: Il-1, Il-6, Il-10, tnf-alpha	at baseline and 10 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difficulties in emotion regulation self-report scale (DERS)	Questions about emotions and emotion regulation	at baseline and 10 weeks
Handgrip strength	Uses dynamometer to assess handgrip strength	at baseline and 10 weeks

Collaborators and Investigators

• Sponsor: The Miriam Hospital
• Collaborators: Brown University
• Investigators: Principal Investigator: Catherine Kerr, PhD, Women's Medicine Collaborative, Miriam Hospital

Publications and helpful links

General Publications

• Kerr CE, Sacchet MD, Lazar SW, Moore CI, Jones SR. Mindfulness starts with the body: somatosensory attention and top-down modulation of cortical alpha rhythms in mindfulness meditation. Front Hum Neurosci. 2013 Feb 13;7:12. doi: 10.3389/fnhum.2013.00012. eCollection 2013.
• Schmalzl L, Kerr CE. Editorial: Neural Mechanisms Underlying Movement-Based Embodied Contemplative Practices. Front Hum Neurosci. 2016 Apr 26;10:169. doi: 10.3389/fnhum.2016.00169. eCollection 2016. No abstract available.

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (ANTICIPATED): April 1, 2017
• Study Completion (ANTICIPATED): December 1, 2017

Study Registration Dates

• First Submitted: July 15, 2016
• First Submitted That Met QC Criteria: July 26, 2016
• First Posted (ESTIMATE): July 27, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): August 1, 2016
• Last Update Submitted That Met QC Criteria: July 28, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Exercise; Cancer; Fatigue; EEG; HRV; Qigong; Mind-Body
• Additional Relevant MeSH Terms: Fatigue
• Other Study ID Numbers: MiriamH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study data will be archived with with computer scripts into a package. These packages will be available to any investigator who requests them.