The Clinical and Biochemical Effect of Therapeutic Massage on Fatigue and Insomnia in Women With Breast Cancer Receiving Radiation Therapy
NCT ID: NCT01071109
Last Updated: 2010-02-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
48 participants
INTERVENTIONAL
2010-11-30
2012-04-30
Brief Summary
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The primary purpose of the proposed research is to study the impact of massage therapy as a tool for the management of fatigue and insomnia experienced by women diagnosed with breast cancer and receiving radiation therapy.
The secondary purpose is to explain, at the biochemical level, the effect of therapeutic massage on the level of fatigue and insomnia in radiation therapy patients. Prior studies have shown an association between fatigue and insomnia in the breast cancer patient following radiation therapy and the presence of inflammation as evidenced by increased proinflammatory cytokine production. The investigators hypothesize that therapeutic massage will ameliorate the symptoms of fatigue and insomnia associated with radiation therapy, and will be associated with a reduction in the plasma levels of interleukin-6 (IL-6),soluble IL-6 receptor (sIL-6R/CD126), and C-Reactive Protein (CRP). This reduction in proinflammatory biomarkers will be due to the activation of the cholinergic anti-inflammatory pathway via the activation of the vagus nerve.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Therapeutic Massage
Therapeutic Massage
Therapeutic Massage--subjects randomized to this group will receive weekly, one-hour therapeutic massage
No therapeutic massage
No interventions assigned to this group
Interventions
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Therapeutic Massage
Therapeutic Massage--subjects randomized to this group will receive weekly, one-hour therapeutic massage
Eligibility Criteria
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Inclusion Criteria
* \> or = 18 years of age and
* diagnosed with breast cancer and
* undergoing radiation therapy and
* willing to follow protocol requirements
Exclusion Criteria
* Presence of an underlying disease that is anticipated to be fatal w/in 6 mo
* Long term steroid medications in the past year or
* Plans to move out of study region within six months or
* Receiving regular body work over the past six months
18 Years
FEMALE
No
Sponsors
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Indiana University
OTHER
Floyd Memorial Hospital and Health Services
OTHER
Responsible Party
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Indiana University Southeast
Principal Investigators
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Judith G Myers, PhD
Role: PRINCIPAL_INVESTIGATOR
Indiana University Southeast
Locations
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FMHHS Cancer Care Center
New Albany, Indiana, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RTTM301
Identifier Type: -
Identifier Source: org_study_id
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