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

NCT ID: NCT00288795

Last Updated: 2011-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2011-11-30

Brief Summary

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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

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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 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.

Conditions

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Fatigue

Keywords

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Fatigue Polarity Massage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Standard Care

Group Type NO_INTERVENTION

No interventions assigned to this group

2

Massage Treatment

Group Type OTHER

Massage Therapy

Intervention Type OTHER

Therapeutic Touch

3

Polarity Treatment

Group Type OTHER

Polarity Therapy

Intervention Type OTHER

Use of energy fields to alleviate distress and achieve balance in the body

Interventions

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Massage Therapy

Therapeutic Touch

Intervention Type OTHER

Polarity Therapy

Use of energy fields to alleviate distress and achieve balance in the body

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Rochester

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karen Mustian, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

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University of Rochester James P. Wilmot Cancer Center

Rochester, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 21382958 (View on PubMed)

Other Identifiers

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URCC U4104

Identifier Type: -

Identifier Source: org_study_id