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

NCT01071109 | Unknown

• 1 other identifier: RTTM301
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Fatigue; Insomnia

Keywords

Therapeutic massage; massage; inflammation; fatigue; insomnia; radiation therapy; breast cancer; Breast Cancer patients receiving radiation therapy

Outcome Measures

Primary Outcomes (1)

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

  Baseline, End of Treatment (6 weeks), End of Study (3 months after End of Treatment)

Secondary Outcomes (1)

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

  Baseline, End of Treatment (6 weeks)

Study Arms (2)

Therapeutic Massage

EXPERIMENTAL

Procedure: Therapeutic Massage

No therapeutic massage

NO INTERVENTION

Interventions

Therapeutic Massage PROCEDURE

Therapeutic Massage--subjects randomized to this group will receive weekly, one-hour therapeutic massage

Therapeutic Massage

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• female patients and
• \> or = 18 years of age and
• diagnosed with breast cancer and
• undergoing radiation therapy and
• willing to follow protocol requirements

You may not qualify if:

• 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

Sponsors & Collaborators

• Floyd Memorial Hospital and Health Services: lead
• Indiana University: collaborator

Study Sites (1)

FMHHS Cancer Care Center

New Albany, Indiana, 47150, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Fatigue; Sleep Initiation and Maintenance Disorders; Inflammation

Interventions

Massage

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Pathologic Processes

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Judith G Myers, PhD

  Indiana University Southeast

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Judith G Myers, PhD

CONTACT

812-941-2695; judymyer@ius.edu

Anthony E Dragun, MD

CONTACT

812- 945-4000; aedrag01@louisville.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 16, 2010
• First Posted: February 19, 2010
• Study Start: November 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: April 1, 2012
• Last Updated: February 19, 2010

Record last verified: 2010-02

Locations

US (1)