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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Rochester
ClinicalTrials.gov Identifier:
NCT00288795
First received: February 6, 2006
Last updated: November 30, 2011
Last verified: November 2011
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Study of Polarity or Massage Therapy to Reduce Fatigue in Breast Cancer Patients During Radiation Therapy

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • 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. [ Time Frame: 4 wk ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Health -Related Quality of Life: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F). Quality of sleep assessed subjectively with Pittsburgh Sleep Quality Inventory and a Sleep Diary. [ Time Frame: 4 wk ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: January 2006
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
Standard Care
2
Massage Treatment
Other: Massage Therapy
Therapeutic Touch
3
Polarity Treatment
Other: Polarity Therapy
Use of energy fields to alleviate distress and achieve balance in the body

Detailed 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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00288795

Locations
United States, New York
University of Rochester James P. Wilmot Cancer Center
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Karen Mustian, Ph.D. University of Rochester
  More Information

No publications provided by University of Rochester

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Rochester
ClinicalTrials.gov Identifier: NCT00288795     History of Changes
Other Study ID Numbers: URCC U4104
Study First Received: February 6, 2006
Last Updated: November 30, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rochester:
Fatigue
Polarity
Massage

Additional relevant MeSH terms:
Breast Neoplasms
Fatigue
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014