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

Fatigue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00288795
• Other study ID #: URCC U4104
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 6, 2006
• Last updated: November 30, 2011
• Start date: January 2006
• Est. completion date: November 2011

Study information

• Verified date: November 2011
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatigue

Intervention

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

Locations

Country	Name	City	State
United States	University of Rochester James P. Wilmot Cancer Center	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No