Clinical trial NCT03259438: The Vitality Project for Fatigued Female Cancer Survivors
Official title: Testing the Effects of Movement Based Interventions on Brain-Body Mechanisms in Fatigued Cancer Survivors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fatigue
Cancer Survivorship
Keywords: Qigong
Comprehensive Health Improvement Program (CHIP)
Pre-Train Injury Prevention Program
Cancer Related Fatigue
Cancer Survivorship
Inflammation
Flowmetry
Corticomuscular coherence
Heart Rate Variability
Neuroimmune Interactions
Complex Systems Analysis
Female
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
Collaborators: name: Brown University
First posted: 2017-08-23
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This parallel, randomized non-inferiority trial will test whether qigong is not inferior to an exercise/nutrition active comparator group in terms of reducing fatigue in female cancer survivors. If non-inferiority is demonstrated during analysis, a secondary analysis will test whether qigong can be considered superior to the exercise-nutrition comparator
Primary purpose: TREATMENT

Brief summary: This parallel, randomized, non-inferiority trial will examine whether a ten week qigong intervention is not inferior to a ten week exercise-nutrition comparison group in reducing fatigue in cancer survivors. To build a more mechanistic understanding of physiological changes associated with fatigue reduction, it will secondly collect several different types of data to build an integrative brain-body model of vigor in cancer survivorship including:

1. data related to neural correlates of body awareness: cortical EEG data measuring each subject's ability to use attention to control neurons in primary somatosensory cortex (replication of Kerr et al 2011 study in mindfulness), and resting state fMRI measures of insular connectivity with nodes of the default mode network and salience network
2. data related to inflammation measured via inflammatory cytokines (e.g., interleukin-6 and tnf-alpha)
3. data related to cardiorespiratory functioning including cardiac impedance (ICG) and mechanical lung function
4. data related to parasympathetic and sympathetic signaling between the nervous system and the rest of the periphery.

Detailed description: The purpose of this study is to examine the therapeutic effects of movement and body awareness on recovery from cancer-related fatigue. In the current study, 60-80 female cancer survivors with cancer-related fatigue will be recruited who have been out of treatment for at least eight weeks. They will be randomized to either a 10-week qigong contemplative movement course or a 10 -week exercise-nutrition course. This study is designed as a non-inferiority trial to test the primary hypothesis that a ten week qigong intervention is not inferior to a ten week exercise-nutrition active comparator group in reducing fatigue in female cancer survivors (assessed via the FACIT-Fatigue scale). If non-inferiority is demonstrated during analysis, the data will be further analyzed to examine whether the qigong group significantly decreases fatigue more than the healthy living comparison group. The FACIT-Fatigue scale will be delivered at three time points: before the intervention starts (T1), after it ends (T2), and three months after the intervention has ended (T3). Further, this study will directly examine the underlying physiological mechanisms by which each intervention exerts its effects. Participants will be tested pre (T1) and post (T2) intervention on a variety of measures across multiple bodily and brain systems (eg EEG, fMRI, EMG, ECG, ICG, mechanical lung function, Doppler flowmetry, serum cytokines, muscle strength, 6 min walk test) to assess changes in these systems that are associated with reduction of fatigue and improvement of the subjective sense of vitality and energy. The data will be used to test whether conscious attention to bodily sensations cultivated in contemplative movement practices (i.e. Qigong) can actually impact levels of inflammation in the periphery as well as cortical measures of interoceptive awareness (ie resting state insula connectivity), and whether these changes will be associated with fatigue reduction. The secondary hypothesis is that decreased inflammation levels in the blood will be correlated with reduction in fatigue at post intervention as well as changes in neural markers of interoceptive and bodily awareness, and that this effect will be stronger in the qigong group.

Eligibility criteria: Inclusion Criteria:

* Female patients
* Aged 18-70 years
* Have completed a course of chemotherapy cancer treatment (except for ongoing treatment with Herceptin \[trastuzumab\] or other adjuvant therapies), AND/OR radiation treatment, AND/OR surgery, with no surgery, radiation or chemotherapy received in the past 8 weeks.
* Endorse a 3/10 or above for the question "On a scale of one to ten, in the last week, how much has your fatigue interfered with your daily life, with 1 being not at all, and 10 being all the time" AND/OR "On a scale of one to ten, in the last week, how much have you felt your sleep has been disturbed or of a quality that you have not felt rested when you wake up, with 1 being not at all, and 10 being all the time"
* Have a primary care or other physician
* Ability to understand English
* Willingness to have blood drawn
* Willingness to have an EEG, EKG, and EMG taken
* Willingness to complete questionnaires
* Willingness and ability to undergo an fMRI scan (screening parameters for this are included below) \[optional: participant doesn't have to do this if it will represent too much burden to the participant, or if they have other contraindications to fMRI such as metal in the body, etc.\]
* 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 and exercise practices

Exclusion Criteria:

* History or current diagnosis of coronary artery or coronary heart disease
* History or current diagnosis of heart attack, or heart murmur
* Electrical Pacemaker Implant in heart
* Peripheral neuropathy in hands
* History or current diagnosis of any other MAJOR psychiatric disorder (including psychosis, or mania, or suicidal or homicidal ideation) besides depression or anxiety
* Active alcohol or drug abuse
* Tobacco use
* Pregnancy
* Ingestion of caffeine or cocoa products less than two hours from data collection
* Inability to participate in gentle exercises (like pilates)

Primary outcomes:
measure: Reduction in Fatigue (via FACIT-Fatigue scale)
timeFrame: Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3)
Secondary outcomes:
measure: Electrocardiogram (ECG)
timeFrame: Measured at baseline (time 1) and after 10-week intervention (time 2)
measure: Impedance Cardiography
timeFrame: Measured at baseline (time 1) and after 10-week intervention (time 2)
measure: Electroencephalography (EEG)
timeFrame: Measured at baseline (time 1) and after 10-week intervention (time 2)
measure: Tactile Acuity
timeFrame: Measured at baseline (time 1) and after 10-week intervention (time 2)
measure: Electromyography (EMG)
timeFrame: Measured at baseline (time 1) and after 10-week intervention (time 2)
measure: Precision Grip
timeFrame: Measured at baseline (time 1) and after 10-week intervention (time 2)
measure: Electrodermal Activity (skin conductance)
timeFrame: Measured at baseline (time 1) and after 10-week intervention (time 2)
measure: Working memory capacity (WMC)
timeFrame: Measured at baseline (time 1) and after 10-week intervention (time 2)
measure: Mechanical lung function
timeFrame: Measured at baseline (time 1) and after 10-week intervention (time 2)
measure: Inflammatory cytokines (eg Il-1, Il-6) collected via a blood draw
timeFrame: Measured at baseline (time 1) and after 10-week intervention (time 2)
measure: Resting State Functional Magnetic Resonance Imaging (rs-fMRI)
timeFrame: Measured at baseline (time 1) and after 10-week intervention (time 2)
measure: Muscle Strength
timeFrame: Measured at baseline (time 1) and after 10-week intervention (time 2)
measure: 6 Minute Walk Test
timeFrame: Measured at baseline (time 1) and after 10-week intervention (time 2)
measure: Patient Health Questionnaire
timeFrame: Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3)
measure: Functional Assessment of cancer therapy-General (FACT-G) Questionnaire
timeFrame: Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3)
measure: Multidimensional Assessment of Interoceptive Awareness (MAIA) Questionnaire
timeFrame: Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3)
measure: Profile of Mood States (POMS) Questionnaire
timeFrame: Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3)
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3)
measure: Rand 36-Item Short Form Health Survey (SF-36)
timeFrame: Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3)
measure: Difficulties in Emotion Regulation Scale (DERS)
timeFrame: Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3)
measure: Fatigue Symptom Inventory (FSI)
timeFrame: Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3)
Other outcomes:
measure: Apple watches Heart Rate and Physical Steps Tracking
timeFrame: Optional Measure: For those involved, tracked daily for five days before the intervention starts, for the 70 days during the 10-week intervention, and for five days after the intervention ends.
measure: Perceived Stress Scale (PSS) Questionnaire
timeFrame: Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3)
measure: Multidimensional Scale of Perceived Social Support (MSPSS)
timeFrame: Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3)
measure: Unmitigated Communion Scale
timeFrame: Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3)
measure: Godin Leisure time Questionnaire
timeFrame: Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3)
Locations:
city: Providence
country: United States
facility: Miriam Hospital Outpatient 146 West River Street
state: Rhode Island
Study officials:
affiliation: The Miriam Hospital
name: Ellen Flynn, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Farb N, Daubenmier J, Price CJ, Gard T, Kerr C, Dunn BD, Klein AC, Paulus MP, Mehling WE. Interoception, contemplative practice, and health. Front Psychol. 2015 Jun 9;6:763. doi: 10.3389/fpsyg.2015.00763. eCollection 2015.
citation: Desbordes G, Gard T, Hoge EA, Holzel BK, Kerr C, Lazar SW, Olendzki A, Vago DR. Moving beyond Mindfulness: Defining Equanimity as an Outcome Measure in Meditation and Contemplative Research. Mindfulness (N Y). 2014 Jan 21;2014(January):356-72. doi: 10.1007/s12671-013-0269-8.
citation: Wells RE, Yeh GY, Kerr CE, Wolkin J, Davis RB, Tan Y, Spaeth R, Wall RB, Walsh J, Kaptchuk TJ, Press D, Phillips RS, Kong J. Meditation's impact on default mode network and hippocampus in mild cognitive impairment: a pilot study. Neurosci Lett. 2013 Nov 27;556:15-9. doi: 10.1016/j.neulet.2013.10.001. Epub 2013 Oct 10.
citation: Daubenmier J, Sze J, Kerr CE, Kemeny ME, Mehling W. Follow your breath: respiratory interoceptive accuracy in experienced meditators. Psychophysiology. 2013 Aug;50(8):777-89. doi: 10.1111/psyp.12057. Epub 2013 May 22.
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: Kerr CE, Jones SR, Wan Q, Pritchett DL, Wasserman RH, Wexler A, Villanueva JJ, Shaw JR, Lazar SW, Kaptchuk TJ, Littenberg R, Hamalainen MS, Moore CI. Effects of mindfulness meditation training on anticipatory alpha modulation in primary somatosensory cortex. Brain Res Bull. 2011 May 30;85(3-4):96-103. doi: 10.1016/j.brainresbull.2011.03.026. Epub 2011 Apr 8.
citation: Mehling WE, Wrubel J, Daubenmier JJ, Price CJ, Kerr CE, Silow T, Gopisetty V, Stewart AL. Body Awareness: a phenomenological inquiry into the common ground of mind-body therapies. Philos Ethics Humanit Med. 2011 Apr 7;6:6. doi: 10.1186/1747-5341-6-6.
citation: Kerr CE, Shaw JR, Wasserman RH, Chen VW, Kanojia A, Bayer T, Kelley JM. Tactile acuity in experienced Tai Chi practitioners: evidence for use dependent plasticity as an effect of sensory-attentional training. Exp Brain Res. 2008 Jun;188(2):317-22. doi: 10.1007/s00221-008-1409-6. Epub 2008 May 30.
citation: Lazar SW, Kerr CE, Wasserman RH, Gray JR, Greve DN, Treadway MT, McGarvey M, Quinn BT, Dusek JA, Benson H, Rauch SL, Moore CI, Fischl B. Meditation experience is associated with increased cortical thickness. Neuroreport. 2005 Nov 28;16(17):1893-7. doi: 10.1097/01.wnr.0000186598.66243.19.