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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Floyd Memorial Hospital and Health Services.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Indiana University
Information provided by:
Floyd Memorial Hospital and Health Services
ClinicalTrials.gov Identifier:
NCT01071109
First received: February 16, 2010
Last updated: February 17, 2010
Last verified: February 2010
History of Changes
  Purpose

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.


Condition Intervention
Breast Cancer
Fatigue
Insomnia
 Procedure: Therapeutic Massage

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: The Clinical and Biochemical Effect of Therapeutic Massage on Fatigue and Insomnia in Women With Breast Cancer Receiving Radiation Therapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Floyd Memorial Hospital and Health Services:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: November 2010
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01071109

Contacts
Contact: Judith G Myers, PhD 812-941-2695 judymyer@ius.edu
Contact: Anthony E Dragun, MD 812- 945-4000 ext Option 3 aedrag01@louisville.edu

Locations
United States, Indiana
FMHHS Cancer Care Center Not yet recruiting
New Albany, Indiana, United States, 47150
Contact: Judith G Myers, PhD     812-941-2695     judymyer@ius.edu    
Contact: Krystal S Angevine, MSW     812-949-5989     kangevine@fmhhs.com    
Principal Investigator: Judith G Myers, PhD            
Sub-Investigator: Anthony E Dragun, MD            
Sponsors and Collaborators
Floyd Memorial Hospital and Health Services
Indiana University
Investigators
Principal Investigator: Judith G Myers, PhD Indiana University Southeast
  More Information

No publications provided

Responsible Party: Judith G. Myers, PhD, Indiana University Southeast
ClinicalTrials.gov Identifier: NCT01071109     History of Changes
Other Study ID Numbers: RTTM301
Study First Received: February 16, 2010
Last Updated: February 17, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Floyd Memorial Hospital and Health Services:
Therapeutic massage
massage
inflammation
fatigue
 insomnia
radiation therapy
breast cancer
Breast Cancer patients receiving radiation therapy

Additional relevant MeSH terms:
Breast Neoplasms
Fatigue
Sleep Initiation and Maintenance Disorders
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
 Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Mental Disorders

ClinicalTrials.gov processed this record on May 21, 2013