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

February 17, 2010 updated by: Floyd Memorial Hospital and Health Services

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • New Albany, Indiana, United States, 47150
        • FMHHS Cancer Care Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Therapeutic Massage
Procedure: Therapeutic Massage
Therapeutic Massage--subjects randomized to this group will receive weekly, one-hour therapeutic massage
No Intervention: No therapeutic massage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fatigue Symptom Inventory, Pittsburgh Sleep Quality Index, and Insomnia Severity Index scores over time.
Time Frame: Baseline, End of Treatment (6 weeks), End of Study (3 months after End of Treatment)
Baseline, End of Treatment (6 weeks), End of Study (3 months after End of Treatment)

Secondary Outcome Measures

Outcome Measure
Time Frame
Plasma levels of proinflammatory markers: interleukin-6 (IL-6), soluble IL-6 receptor (sIL-6R/CD126), and C-Reactive Protein (CRP).
Time Frame: Baseline, End of Treatment (6 weeks)
Baseline, End of Treatment (6 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Floyd Memorial Hospital and Health Services

Collaborators

Indiana University

Investigators

  • Principal Investigator: Judith G Myers, PhD, Indiana University Southeast

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Anticipated)

October 1, 2011

Study Completion (Anticipated)

April 1, 2012

Study Registration Dates

First Submitted

February 16, 2010

First Submitted That Met QC Criteria

February 17, 2010

First Posted (Estimate)

February 19, 2010

Study Record Updates

Last Update Posted (Estimate)

February 19, 2010

Last Update Submitted That Met QC Criteria

February 17, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RTTM301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Clinical Trials on Therapeutic Massage

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cameroon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe