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

Not Applicable

• Conditions: Breast Cancer; Fatigue; Insomnia
• Interventions: Procedure: Therapeutic Massage

• Registration Number: NCT01071109
• Lead Sponsor: Floyd Memorial Hospital and Health Services

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-02
• Study First Submitted: 2010-02-16
• Study First Submitted QC: 2010-02-17
• Last Update Submitted: 2010-02-17
• Study First Posted: 2010-02-19
• Last Update Posted: 2010-02-19
• Study Start: 2010-11
• Primary Completion: 2011-10
• Study Completion: 2012-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Therapeutic Massage	Therapeutic Massage	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (1)

FMHHS Cancer Care Center; 🇺🇸 New Albany, Indiana, United States