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

February 16, 2010
February 17, 2010
November 2010
October 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01071109 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
The Clinical and Biochemical Effect of Therapeutic Massage on Fatigue and Insomnia in Women With Breast Cancer Receiving Radiation Therapy
The Clinical and Biochemical Effect of Therapeutic Massage on Fatigue and Insomnia in Women With Breast Cancer Receiving Radiation Therapy

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Breast Cancer
  • Fatigue
  • Insomnia
Procedure: Therapeutic Massage
Therapeutic Massage--subjects randomized to this group will receive weekly, one-hour therapeutic massage
  • Experimental: Therapeutic Massage
    Intervention: Procedure: Therapeutic Massage
  • No Intervention: No therapeutic massage
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
48
April 2012
October 2011   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
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
United States
 
NCT01071109
RTTM301
No
Judith G. Myers, PhD, Indiana University Southeast
Floyd Memorial Hospital and Health Services
Indiana University
Principal Investigator: Judith G Myers, PhD Indiana University Southeast
Floyd Memorial Hospital and Health Services
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP