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

University of Rochester

Status and phase: Completed; Phase 2; Phase 1

Conditions: Fatigue

Treatments: Other: Massage Therapy; Other: Polarity Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00288795

URCC U4104

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: Female

Ages: 21+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 3 patient groups

1

No Intervention group

Description:

Standard Care

2

Other group

Description:

Massage Treatment

Treatment:

Other: Massage Therapy

3

Other group

Description:

Polarity Treatment

Treatment:

Other: Polarity Therapy