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| Sponsored by: |
University of Rochester |
|---|---|
| Information provided by: | University of Rochester |
| ClinicalTrials.gov Identifier: | NCT00288795 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Fatigue |
Other: Massage Therapy Other: Polarity Therapy |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
| Official Title: | A Randomized Study of Polarity or Massage Therapy to Reduce Fatigue in Breast Cancer Patients During Radiation Therapy |
| Estimated Enrollment: | 60 |
| Study Start Date: | January 2006 |
| Estimated Study Completion Date: | September 2008 |
| Arms | Assigned Interventions |
|---|---|
|
1: No Intervention
Standard Care
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2
Massage Treatment
|
Other: Massage Therapy
Therapeutic Touch
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3
Polarity Treatment
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Other: Polarity Therapy
Use of energy fields to alleviate distress and achieve balance in the body
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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 consent 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.
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, New York | |
| University of Rochester James P. Wilmot Cancer Center | |
| Rochester, New York, United States, 14642 | |
| Principal Investigator: | Karen Mustian, Ph.D. | University of Rochester |
More Information
| Responsible Party: | University of Rocheter ( Karen Mustian ) |
| Study ID Numbers: | URCC U4104 |
| Study First Received: | February 6, 2006 |
| Last Updated: | July 30, 2008 |
| ClinicalTrials.gov Identifier: | NCT00288795 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Fatigue Polarity Massage |
|
Signs and Symptoms Fatigue Skin Diseases Breast Neoplasms Breast Diseases |
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Signs and Symptoms Neoplasms Neoplasms by Site Fatigue |
Skin Diseases Breast Neoplasms Breast Diseases |
