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

Fatigue Clinical Trial

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

Clinical Trial Summary

This research study is being conducted to compare the effectiveness of two types of complimentary medicine treatments to see if they will reduce the fatigue experienced by breast cancer patients receiving radiation therapy. The treatments being studied are Polarity Therapy and Massage Therapy.

The primary study hypothesis is that Polarity Therapy will be efficacious in relieving fatigue in breast cancer patients receiving radiation treatments.

The secondary hypothesis is that Polarity Therapy will be efficacious in improving health-related quality of life in breast cancer patients receiving radiation treatments.

Clinical Trial Description

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. ;

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00288795
Study type Interventional
Source University of Rochester
Contact
Status Completed
Phase Phase 1/Phase 2
Start date January 2006
Completion date November 2011
View Details
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