Evaluating Qigong as a Clinical Intervention for Cancer Survivors' Fatigue

NCT ID: NCT02845492

Last Updated: 2016-08-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2017-12-31

Brief 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.

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.

Conditions

Fatigue

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Qigong

Intervention Type: OTHER

Qigong is a mind-body exercise based around gentle exercise and the cultivation of a meditative focus on bodily sensations

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.

Group Type: ACTIVE_COMPARATOR

Complete Health Improvement Program (CHIP)

Intervention Type: OTHER

The CHIP program is a validated weekly wellness and exercise program designed to promote health and wellbeing.

Interventions

Qigong

Qigong is a mind-body exercise based around gentle exercise and the cultivation of a meditative focus on bodily sensations

Intervention Type: OTHER

Complete Health Improvement Program (CHIP)

The CHIP program is a validated weekly wellness and exercise program designed to promote health and wellbeing.

Intervention Type: OTHER

Other Intervention Names

Meditative Exercise Therapy; Wellness-Exercise Program

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Brown University

OTHER

Sponsor Role: collaborator

The Miriam Hospital

OTHER

Sponsor Role: lead

Responsible Party

Catherine Kerr

Assistant Professor of Family Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Catherine Kerr, PhD

Role: PRINCIPAL_INVESTIGATOR

Women's Medicine Collaborative, Miriam Hospital

Locations

Miriam Hospital

Providence, Rhode Island, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Chloe Zimmerman, BA

Role: CONTACT

chloe_zimmerman@brown.edu

4018636272

Brendan Cullen, BA

Role: CONTACT

Brendan_Cullen@brown.edu

4018636272

Facility Contacts

Chloe Zimmerman

Role: primary

cancersurvivor@lifespan.org

401-863-6272

References

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.

Reference Type: BACKGROUND

PMID: 23408771 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27199700 (View on PubMed)

Other Identifiers

MiriamH

Identifier Type: -

Identifier Source: org_study_id