Clincosm LogoSign in Get a demo

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

Sponsor
University of Rochester (Other)
Overall Status
Completed
CT.gov ID
NCT00288795
Collaborator
(none)
45
Enrollment
1
Location
3
Arms
70
Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Massage Therapy
  • Other: Polarity Therapy
 Phase 1/Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (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
Study Start Date :
Jan 1, 2006
Actual Primary Completion Date :
Nov 1, 2011
Actual Study Completion Date :
Nov 1, 2011

Arms and Interventions

Arm Intervention/Treatment
No Intervention: 1

Standard Care
Other: 2

Massage Treatment

Other: Massage Therapy
Therapeutic Touch
Other: 3

Polarity Treatment

Other: Polarity Therapy
Use of energy fields to alleviate distress and achieve balance in the body

Outcome Measures

Primary Outcome Measures

  1. 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. [4 wk]

Secondary Outcome Measures

  1. 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. [4 wk]

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University of Rochester
ClinicalTrials.gov Identifier:
NCT00288795
Other Study ID Numbers:
  • URCC U4104
First Posted:
Feb 8, 2006
Last Update Posted:
Dec 1, 2011
Last Verified:
Nov 1, 2011
Keywords provided by University of Rochester
Fatigue
Polarity
Massage
Additional relevant MeSH terms:
Fatigue

Study Results

No Results Posted as of Dec 1, 2011