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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)

Primary Purpose

Breast Cancer, Fatigue, Insomnia

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Therapeutic Massage
Sponsored by
Floyd Memorial Hospital and Health Services
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Therapeutic massage, massage, inflammation, fatigue, insomnia, radiation therapy, breast cancer, Breast Cancer patients receiving radiation therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • FMHHS Cancer Care Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Therapeutic Massage

No therapeutic massage

Arm Description

Outcomes

Primary Outcome Measures

Fatigue Symptom Inventory, Pittsburgh Sleep Quality Index, and Insomnia Severity Index scores over time.

Secondary Outcome Measures

Plasma levels of proinflammatory markers: interleukin-6 (IL-6), soluble IL-6 receptor (sIL-6R/CD126), and C-Reactive Protein (CRP).

Full Information

First Posted
February 16, 2010
Last Updated
February 17, 2010
Sponsor
Floyd Memorial Hospital and Health Services
Collaborators
Indiana University
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1. Study Identification

Unique Protocol Identification Number
NCT01071109
Brief Title
The Clinical and Biochemical Effect of Therapeutic Massage on Fatigue and Insomnia in Women With Breast Cancer Receiving Radiation Therapy
Acronym
RTTM301
Official Title
The Clinical and Biochemical Effect of Therapeutic Massage on Fatigue and Insomnia in Women With Breast Cancer Receiving Radiation Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Unknown status
Study Start Date
November 2010 (undefined)
Primary Completion Date
October 2011 (Anticipated)
Study Completion Date
April 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Floyd Memorial Hospital and Health Services
Collaborators
Indiana University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Fatigue, Insomnia
Keywords
Therapeutic massage, massage, inflammation, fatigue, insomnia, radiation therapy, breast cancer, Breast Cancer patients receiving radiation therapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Therapeutic Massage
Arm Type
Experimental
Arm Title
No therapeutic massage
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
Therapeutic Massage
Intervention Description
Therapeutic Massage--subjects randomized to this group will receive weekly, one-hour therapeutic massage
Primary Outcome Measure Information:
Title
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)
Secondary Outcome Measure Information:
Title
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)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Judith G Myers, PhD
Phone
812-941-2695
Email
judymyer@ius.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Anthony E Dragun, MD
Phone
812- 945-4000
Ext
Option 3
Email
aedrag01@louisville.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judith G Myers, PhD
Organizational Affiliation
Indiana University Southeast
Official's Role
Principal Investigator
Facility Information:
Facility Name
FMHHS Cancer Care Center
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Judith G Myers, PhD
Phone
812-941-2695
Email
judymyer@ius.edu
First Name & Middle Initial & Last Name & Degree
Krystal S Angevine, MSW
Phone
812-949-5989
Email
kangevine@fmhhs.com
First Name & Middle Initial & Last Name & Degree
Judith G Myers, PhD
First Name & Middle Initial & Last Name & Degree
Anthony E Dragun, MD

12. IPD Sharing Statement

Learn more about this trial

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

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