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

Phase 1

Completed

• Conditions: Fatigue
• Interventions: Other: Massage Therapy; Other: Polarity Therapy

• Registration Number: NCT00288795
• Lead Sponsor: University of Rochester

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.

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2006-02-06
• Study First Submitted QC: 2006-02-07
• Study First Posted: 2006-02-08
• Status Verified: 2011-11
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Last Update Submitted: 2011-11-30
• Last Update Posted: 2011-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 45

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
2	Massage Therapy	Massage Treatment
3	Polarity Therapy	Polarity Treatment

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

University of Rochester James P. Wilmot Cancer Center; 🇺🇸 Rochester, New York, United States