The Vitality Project for Fatigued Female Cancer Survivors
Status unconfirmed · Not applicable
Conditions studied: Fatigue, Cancer Survivorship
In brief
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.
Key facts
- Study ID
- NCT03259438
- Run by
- The Miriam Hospital
- People needed
- 75
- Starts
- 2017-07-24
- Expected to finish
- 2018-01-30
- Last updated by the study team
- 2017-08-23
Who can join
Age: 18 and older, up to 70. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- Miriam Hospital Outpatient 146 West River Street — Providence, Rhode Island, United States (enrolling)
Full record on ClinicalTrials.gov
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