A Randomized Study of Polarity or Massage Therapy to Reduce Fatigue in Breast Cancer Patients During Radiation Therapy
1 other identifier
interventional
45
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jan 2006
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 6, 2006
CompletedFirst Posted
Study publicly available on registry
February 8, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedDecember 1, 2011
November 1, 2011
5.8 years
February 6, 2006
November 30, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Study Arms (3)
1
NO INTERVENTIONStandard Care
2
OTHERMassage Treatment
3
OTHERPolarity Treatment
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of breast cancer
- Fatigue of 2 or greater on Symptom Inventory
- Received at least 8 radiation treatments
- Able to read English
You may not qualify if:
- Be receiving concurrent chemotherapy
- Have bone metastasizes
- Be taking methylphenidate, modafinil, sedatives, or anxiolytics
- Have a hemoglobin \<11g/dL.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Rochester James P. Wilmot Cancer Center
Rochester, New York, 14642, United States
Related 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.
PMID: 21382958BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karen Mustian, Ph.D.
University of Rochester
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 6, 2006
First Posted
February 8, 2006
Study Start
January 1, 2006
Primary Completion
November 1, 2011
Study Completion
November 1, 2011
Last Updated
December 1, 2011
Record last verified: 2011-11