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A Randomized Study of Polarity or Massage Therapy to Reduce Fatigue in Breast Cancer Patients During Radiation Therapy

Phase 1/Phase 2
21 Years
Not Enrolling

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Trial Information

A Randomized Study of Polarity or Massage Therapy to Reduce Fatigue in Breast Cancer Patients During Radiation Therapy

This is a randomized three-arm clinical trial of an intervention examining the efficacy of
Polarity Therapy for the relief of fatigue associated with radiation treatments in breast
cancer patients. Patients who meets the eligibility criteria and who have signed the
consent form will be randomized to one of three trial arms: 1) Polarity Treatment 2)
Massage treatment 3) Standard Care. Three treatments will be administered in the 4th, 5th,
and 6th calendar weeks of radiation treatment. There will be weekly blood draws to assess
cytokine levels. In addition, 6 saliva samples will be gathered per day for 2 days during
each of the 4 study weeks to assess cortisol levels. Saliva samples will be completed by
the participant at home. An actigraph will be worn for the 28 day study period to assess
activity and sleep. Patients randomized to the Standard Care Arm will receive a Polarity or
Massage treatment gratis following the completion of the study.

Inclusion Criteria:

- Diagnosis of breast cancer

- Fatigue of 2 or greater on Symptom Inventory

- Received at least 8 radiation treatments

- Able to read English

Exclusion Criteria:

- Be receiving concurrent chemotherapy

- Have bone metastasizes

- Be taking methylphenidate, modafinil, sedatives, or anxiolytics

- Have a hemoglobin <11g/dL.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Fatigue: Brief Fatigue Inventory and the Multidimensional Fatigue Symptom Inventory; objectively via actigraphy; mood via the Fatigue/Inertia subscale of the Monopolar Profile of Mood States.

Outcome Time Frame:

4 wk

Safety Issue:


Principal Investigator

Karen Mustian, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Rochester


United States: Institutional Review Board

Study ID:

URCC U4104



Start Date:

January 2006

Completion Date:

November 2011

Related Keywords:

  • Fatigue
  • Fatigue
  • Polarity
  • Massage
  • Breast Neoplasms
  • Fatigue



University of Rochester James P. Wilmot Cancer Center Rochester, New York  14642