Recruiting

Observational StudyThe Vitality Project for Fatigued Female Cancer Survivors

Sponsor:

The Miriam Hospital

Code:

NCT03259438

Conditions

Fatigue

Cancer Survivorship

Eligibility Criteria

Sex: Female

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Qigong

Healthy Living (CHIP + Pre-Train)

Study Details

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.

Conditions

Fatigue

Cancer Survivorship

Study ID

NCT03259438

Start date

Jul 24, 2017

Status verified date

Aug, 2017

Completion date

Jan 30, 2018

Anticipated

Primary completion date

Dec 20, 2017

Anticipated

Eligibility Criteria

Sex: Female

Age: 18 - 70

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

75 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Qigong

This course will meet twice weekly for 2 hours and 15 minutes per class for ten weeks. Topics will include guided instruction in the theory and background of qigong and healing. Practice will include gentle stretching and guided qigong movement as well as seated and lying down meditations. Participants will be asked to complete about 30 minutes a day of home assignments.

active comparator: Healthy Living (CHIP + Pre-Train)

This course will meet twice weekly for 2 hours and 15 minutes per class for ten weeks. Topics will include plant based nutrition counseling via the Comprehensive Health Improvement Program (CHIP) as well as core-stretching, strengthening, and light aerobic movements through a Pre-Train exercise program. Participants will be asked to complete about 30 minutes a day of home assignments.

Interventions

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.

Primary outcome measure

Reduction in Fatigue (via FACIT-Fatigue scale) [ Time Frame: Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3) ]

Central Contacts and Locations

Central contacts

Chloe S Zimmerman, BA

401-863-6272 chloe_zimmerman@brown.edu

Locations

Miriam Hospital Outpatient 146 West River Street

Recruiting

Providence, Rhode Island, United States, 02904

Contacts

Ellen Flynn, MD

401-793-7020 eflynn@lifespan.org

Susan Martin, LDN, IBCLC

401-793-7822 smartin8@lifespan.org

More Information

Sponsor

The Miriam Hospital

Last update posted

Aug 23, 2017

Last verified

Aug, 2017

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Miriam Hospital on 2017-08-23.