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

Breast Cancer Clinical Trial

— RTTM301  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01071109
• Other study ID #: RTTM301
• Status: Not yet recruiting
• Phase: N/A
• First received: February 16, 2010
• Last updated: February 17, 2010
• Start date: November 2010
• Est. completion date: April 2012

Study information

• Verified date: February 2010
• Source: Floyd Memorial Hospital and Health Services
• Contact: Judith G Myers, PhD
• Phone: 812-941-2695
• Email: judymyer[@]ius.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. completion date: April 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Fatigue
• Insomnia

Intervention

Procedure:
• Therapeutic Massage
Therapeutic Massage--subjects randomized to this group will receive weekly, one-hour therapeutic massage

Locations

Country	Name	City	State
United States	FMHHS Cancer Care Center	New Albany	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Floyd Memorial Hospital and Health Services	Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No