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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
Karen Mustian, Ph.D.
University of Rochester
United States: Institutional Review Board
|University of Rochester James P. Wilmot Cancer Center||Rochester, New York 14642|