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


N/A
18 Years
N/A
Not Enrolling
Female
Breast Cancer, Fatigue, Insomnia

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

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

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

Judith G Myers, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Indiana University Southeast

Authority:

United States: Institutional Review Board

Study ID:

RTTM301

NCT ID:

NCT01071109

Start Date:

November 2010

Completion Date:

April 2012

Related Keywords:

  • Breast Cancer
  • Fatigue
  • Insomnia
  • Therapeutic massage
  • massage
  • inflammation
  • fatigue
  • insomnia
  • radiation therapy
  • breast cancer
  • Breast Cancer patients receiving radiation therapy
  • Breast Neoplasms
  • Fatigue
  • Sleep Initiation and Maintenance Disorders

Name

Location
FMHHS Cancer Care Center New Albany, Indiana  47150