Clinical trial NCT02845492: Evaluating Qigong as a Clinical Intervention for Cancer Survivors' Fatigue
Official title: Testing the Effects of Qigong on a Multi-System Neuro-muscular- Immune Model of Vigor in Cancer Survivorship
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fatigue
Keywords: Exercise
Qigong
Mind-Body
Fatigue
Cancer
EEG
HRV
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
Collaborators: name: Brown University
First posted: 2016-07-27
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Fatigue Symptom Inventory Questionnaire
timeFrame: Change from baseline to 10 weeks
Secondary outcomes:
measure: EEG meditative brain measures,
timeFrame: at baseline and at 10 weeks
measure: Self-reported Vitality (a component of the Medical Outcomes Short-Form 36)
timeFrame: at baseline and 10 weeks
measure: Heart Rate Variability (HRV)
timeFrame: at baseline and 10 weeks
measure: Inflammatory cytokines
timeFrame: at baseline and 10 weeks
Other outcomes:
measure: Difficulties in emotion regulation self-report scale (DERS)
timeFrame: at baseline and 10 weeks
measure: Handgrip strength
timeFrame: at baseline and 10 weeks
Locations:
city: Providence
country: United States
facility: Miriam Hospital
state: Rhode Island
Study officials:
affiliation: Women's Medicine Collaborative, Miriam Hospital
name: Catherine Kerr, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.