The Clinical and Biochemical Effect of Therapeutic Massage on Fatigue and Insomnia in Women With Breast Cancer Receiving Radiation Therapy

Study Overview
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Brief Summary
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A majority of women with breast cancer receive radiation therapy, and many of them experience the debilitating side effects of fatigue and insomnia. There is a need for an effective treatment that could ameliorate these symptoms and improve quality of life in the radiation therapy population. 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.

Official Title
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The Clinical and Biochemical Effect of Therapeutic Massage on Fatigue and Insomnia in Women With Breast Cancer Receiving Radiation Therapy

Conditions
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Breast Cancer, Fatigue, Insomnia

Intervention / Treatment
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* Procedure: Therapeutic Massage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: female patients and > or = 18 years of age and diagnosed with breast cancer and undergoing radiation therapy and willing to follow protocol requirements Exclusion Criteria: Stage IV disease or 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Therapeutic Massage<br> | Procedure: Therapeutic Massage<br>* Therapeutic Massage--subjects randomized to this group will receive weekly, one-hour therapeutic massage<br>|
| No Intervention: No therapeutic massage<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue Symptom Inventory, Pittsburgh Sleep Quality Index, and Insomnia Severity Index scores over time. |  | Baseline, End of Treatment (6 weeks), End of Study (3 months after End of Treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma levels of proinflammatory markers: interleukin-6 (IL-6), soluble IL-6 receptor (sIL-6R/CD126), and C-Reactive Protein (CRP). |  | Baseline, End of Treatment (6 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Therapeutic massage, massage, inflammation, fatigue, insomnia, radiation therapy, breast cancer, Breast Cancer patients receiving radiation therapy