The Clinical and Biochemical Effect of Therapeutic Massage on Fatigue and Insomnia in Women With Breast Cancer Receiving Radiation Therapy (RTTM301)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01071109|
Recruitment Status : Unknown
Verified February 2010 by Floyd Memorial Hospital and Health Services.
Recruitment status was: Not yet recruiting
First Posted : February 19, 2010
Last Update Posted : February 19, 2010
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 or disease||Intervention/treatment||Phase|
|Breast Cancer Fatigue Insomnia||Procedure: Therapeutic Massage||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (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|
|Study Start Date :||November 2010|
|Estimated Primary Completion Date :||October 2011|
|Estimated Study Completion Date :||April 2012|
|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|
- 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) ]
- 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) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01071109
|Contact: Judith G Myers, PhDfirstname.lastname@example.org|
|Contact: Anthony E Dragun, MD||812- 945-4000 ext Option email@example.com|
|United States, Indiana|
|FMHHS Cancer Care Center|
|New Albany, Indiana, United States, 47150|
|Contact: Judith G Myers, PhD 812-941-2695 firstname.lastname@example.org|
|Contact: Krystal S Angevine, MSW 812-949-5989 email@example.com|
|Principal Investigator: Judith G Myers, PhD|
|Sub-Investigator: Anthony E Dragun, MD|
|Principal Investigator:||Judith G Myers, PhD||Indiana University Southeast|