The Vitality Project for Fatigued Female Cancer Survivors

Fatigue Clinical Trial

Official title:

Testing the Effects of Movement Based Interventions on Brain-Body Mechanisms in Fatigued Cancer Survivors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03259438
• Other study ID #: MiriamH 1040485
• Status: Recruiting
• Phase: N/A
• First received: July 19, 2017
• Last updated: August 21, 2017
• Start date: July 24, 2017
• Est. completion date: January 30, 2018

Study information

• Verified date: August 2017
• Source: The Miriam Hospital
• Contact: Chloe S Zimmerman, BA
• Phone: 401-863-6272
• Email: chloe_zimmerman[@]brown.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: January 30, 2018
• Est. primary completion date: December 20, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cancer Survivorship
• Fatigue

Intervention

Behavioral:
• Qigong
Qigong is a form of gentle mind-body movement that originates in China and has traditionally been used for healing purposes. It has been reported to improve energy levels, as well as strength and endurance and mental clarity and equanimity. This study will assess how a 10-week qigong intervention compares to an exercise-nutrition intervention in improving fatigue and vitality in female cancer survivors. On a secondary level, we will asses changes in underlying brain, heart, and peripheral dynamics that occur as a result of the qigong practice to develop a mechanistic understanding of qigong's efficacy.
• Healthy Living (CHIP + Pre-Train)
The Healthy Living active comparator intervention includes two components: plant based nutrition counseling via the Comprehensive Health Improvement Program (CHIP) and core strengthening exercises and light aerobic activity via the Pre-Train exercise program.

Locations

Country	Name	City	State
United States	Miriam Hospital Outpatient 146 West River Street	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
The Miriam Hospital	Brown University

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View Citation

Desbordes G, Gard T, Hoge EA, Hölzel 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). doi: 10.1007/s12671-013-0269-8. — View 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. — View Citation

Kerr CE, Jones SR, Wan Q, Pritchett DL, Wasserman RH, Wexler A, Villanueva JJ, Shaw JR, Lazar SW, Kaptchuk TJ, Littenberg R, Hämäläinen 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Apple watches Heart Rate and Physical Steps Tracking	Apple watches will be supplied to interested participants to monitor their heart rate and physical steps taken throughout the day to assess changes in movement patterns while participating in the classes	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.
Other	Perceived Stress Scale (PSS) Questionnaire	To assess changes in self-reported stress	Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3)
Other	Multidimensional Scale of Perceived Social Support (MSPSS)	Measure of self-reported social support	Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3)
Other	Unmitigated Communion Scale	A measure of a person's tendency to care for other's before themselves	Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3)
Other	Godin Leisure time Questionnaire	Measure of how much a person has been excising or relaxing	Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3)
Primary	Reduction in Fatigue (via FACIT-Fatigue scale)	Fatigue assessed via the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) questionnaire	Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3)
Secondary	Electrocardiogram (ECG)	Will be measured to calculate heart rate variability (HRV)	Measured at baseline (time 1) and after 10-week intervention (time 2)
Secondary	Impedance Cardiography	Will be used to assess exercise related improvements in cardiovascular tone.	Measured at baseline (time 1) and after 10-week intervention (time 2)
Secondary	Electroencephalography (EEG)	Will be used to assess changes in cortical brain waves (particularly alpha and beta rhythms)	Measured at baseline (time 1) and after 10-week intervention (time 2)
Secondary	Tactile Acuity	A task that involves subtle taps to the finger tips, EEG is simultaneously recorded to examine modulation in brain rhythms across somatosensory cortex related to cued attention to the tap	Measured at baseline (time 1) and after 10-week intervention (time 2)
Secondary	Electromyography (EMG)	A measure of muscle rhythms	Measured at baseline (time 1) and after 10-week intervention (time 2)
Secondary	Precision Grip	A measure of one's ability to hold a lever at a steady force, EEG and EMG simultaneously record corticomuscular coherence that may facilitate steady grip	Measured at baseline (time 1) and after 10-week intervention (time 2)
Secondary	Electrodermal Activity (skin conductance)	to assess sympathetic tone	Measured at baseline (time 1) and after 10-week intervention (time 2)
Secondary	Working memory capacity (WMC)	Assessed via the short-form O-SPAN computer-based task to assess overall memory impairments	Measured at baseline (time 1) and after 10-week intervention (time 2)
Secondary	Mechanical lung function	to determine the impact of exercise and movement on overall lung function	Measured at baseline (time 1) and after 10-week intervention (time 2)
Secondary	Inflammatory cytokines (eg Il-1, Il-6) collected via a blood draw	To measure the interaction between the brain measures of bodily awareness and the immune system	Measured at baseline (time 1) and after 10-week intervention (time 2)
Secondary	Resting State Functional Magnetic Resonance Imaging (rs-fMRI)	Optional measure: To assess changes in functional connectivity associated with participation in the intervention	Measured at baseline (time 1) and after 10-week intervention (time 2)
Secondary	Muscle Strength	Assessed via jamar hand dynamometers and back, leg, and arm dynamometers to assess changes in muscle tone associated with the classes	Measured at baseline (time 1) and after 10-week intervention (time 2)
Secondary	6 Minute Walk Test	Test of how far a participant can walk in six minutes to assess overall endurance	Measured at baseline (time 1) and after 10-week intervention (time 2)
Secondary	Patient Health Questionnaire	Measure of anxiety and depression	Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3)
Secondary	Functional Assessment of cancer therapy-General (FACT-G) Questionnaire	Measure of physical, social, emotional, and functional well-being	Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3)
Secondary	Multidimensional Assessment of Interoceptive Awareness (MAIA) Questionnaire	Questionnaire to measure subjectively reported interoceptive and bodily awareness (including body-specific sensations, emotions, and cognitions)	Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3)
Secondary	Profile of Mood States (POMS) Questionnaire	To assess fatigue, vigor, and overall mood	Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3)
Secondary	Pittsburgh Sleep Quality Index (PSQI)	Measurement of sleep quality, habits, and patterns	Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3)
Secondary	Rand 36-Item Short Form Health Survey (SF-36)	Measurement of overall quality of life	Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3)
Secondary	Difficulties in Emotion Regulation Scale (DERS)	Measures multiple factors of emotional dysregulation	Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3)
Secondary	Fatigue Symptom Inventory (FSI)	Measures overall fatigue interfrerence	Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3)