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

Primary Purpose

Fatigue

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Massage Therapy
Polarity Therapy
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fatigue focused on measuring Fatigue, Polarity, Massage

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Rochester James P. Wilmot Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Other

Other

Arm Label

1

2

3

Arm Description

Standard Care

Massage Treatment

Polarity Treatment

Outcomes

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.

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.

Full Information

First Posted
February 6, 2006
Last Updated
November 30, 2011
Sponsor
University of Rochester
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1. Study Identification

Unique Protocol Identification Number
NCT00288795
Brief Title
A Randomized Study of Polarity or Massage Therapy to Reduce Fatigue in Breast Cancer Patients During Radiation Therapy
Official Title
A Randomized Study of Polarity or Massage Therapy to Reduce Fatigue in Breast Cancer Patients During Radiation Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Rochester

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue
Keywords
Fatigue, Polarity, Massage

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
No Intervention
Arm Description
Standard Care
Arm Title
2
Arm Type
Other
Arm Description
Massage Treatment
Arm Title
3
Arm Type
Other
Arm Description
Polarity Treatment
Intervention Type
Other
Intervention Name(s)
Massage Therapy
Intervention Description
Therapeutic Touch
Intervention Type
Other
Intervention Name(s)
Polarity Therapy
Intervention Description
Use of energy fields to alleviate distress and achieve balance in the body
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Mustian, Ph.D.
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester James P. Wilmot Cancer Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21382958
Citation
Mustian KM, Roscoe JA, Palesh OG, Sprod LK, Heckler CE, Peppone LJ, Usuki KY, Ling MN, Brasacchio RA, Morrow GR. Polarity Therapy for cancer-related fatigue in patients with breast cancer receiving radiation therapy: a randomized controlled pilot study. Integr Cancer Ther. 2011 Mar;10(1):27-37. doi: 10.1177/1534735410397044. Epub 2011 Mar 7.
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A Randomized Study of Polarity or Massage Therapy to Reduce Fatigue in Breast Cancer Patients During Radiation Therapy

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