Breast Cancer Clinical Trial

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

Summary

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.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Breast Cancer

Estimated Enrollment:

48

Study ID:

NCT01071109

Recruitment Status:

Unknown status

Sponsor:

Floyd Memorial Hospital and Health Services

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There is 1 Location for this study

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FMHHS Cancer Care Center
New Albany Indiana, 47150, United States More Info
Judith G Myers, PhD
Contact
812-941-2695
[email protected]
Krystal S Angevine, MSW
Contact
812-949-5989
[email protected]
Judith G Myers, PhD
Principal Investigator
Anthony E Dragun, MD
Sub-Investigator

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

48

Study ID:

NCT01071109

Recruitment Status:

Unknown status

Sponsor:


Floyd Memorial Hospital and Health Services

How clear is this clinincal trial information?

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