Fatigue
Conditions
Keywords
Fatigue, Polarity, Massage
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.
Interventions
OTHERMassage Therapy
Therapeutic Touch
OTHERPolarity Therapy
Use of energy fields to alleviate distress and achieve balance in the body
Sponsors
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed