Breast Cancer Clinical Trial
Official title:
The Clinical and Biochemical Effect of Therapeutic Massage on Fatigue and Insomnia in Women With Breast Cancer Receiving Radiation Therapy
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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