The Clinical and Biochemical Effect of Therapeutic Massage on Fatigue and Insomnia in Women With Breast Cancer Receiving Radiation Therapy (RTTM301)

Floyd Memorial Hospital and Health Services

Status: Unknown

Conditions: Breast Cancer; Insomnia; Fatigue

Treatments: Procedure: Therapeutic Massage

Study type: Interventional

Funder types: Other

Identifiers

NCT01071109

RTTM301

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

Therapeutic Massage

Experimental group

Treatment:

Procedure: Therapeutic Massage

No therapeutic massage

No Intervention group