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Massage Therapy for Cancer-Related Fatigue
This study has been completed.
Study NCT00039793   Information provided by National Center for Complementary and Alternative Medicine (NCCAM)
First Received: June 11, 2002   Last Updated: August 17, 2006   History of Changes

June 11, 2002
August 17, 2006
March 2001
 
 
 
Complete list of historical versions of study NCT00039793 on ClinicalTrials.gov Archive Site
 
 
 
Massage Therapy for Cancer-Related Fatigue
Massage Therapy for Cancer-Related Fatigue

The purpose of this study is to develop methods for studying the effect of bodywork therapy on symptoms of fatigue in patients undergoing cancer chemotherapy.

The proposed project is a randomized pilot trial of a Swedish-style massage therapy intervention for the treatment of fatigue in patients who are undergoing cancer chemotherapy. Fatigue is the most common complaint of patients receiving treatment for cancer, but is often difficult to treat and causes a substantial decrement in patients' quality of life. Massage therapy is a non-invasive intervention used in many patients with cancer for symptom control. Prior small studies have suggested some efficacy of bodywork therapies in conditions characterized by fatigue, such as fibromyalgia and chronic fatigue syndrome. Based on these results, massage therapy may provide an important adjunct in ameliorating fatigue and enhancing cancer patients' well being.

The proposed study is a 12-week, randomized, three-arm, parallel-comparison clinical trial comparing the effects of a Swedish-style massage regimen to a sham bodywork control and a usual-care group for fatigue reduction in cancer patents undergoing chemotherapy. Patients with breast, ovarian, prostate, or colo-rectal cancer will be enrolled; the primary outcome measure is a quantitative assessment of fatigue symptoms. This study will determine efficacy, functioning, perceptions of fatigue, and quality of life. This study should provide not only important data on the potential efficacy of massage therapy for the treatment of fatigue, but also advance the methodology for studying CAM interventions for difficult-to-treat symptomatic conditions.

Phase II
Interventional
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
  • Breast Neoplasms
  • Ovarian Neoplasms
  • Prostatic Neoplasms
  • Colorectal Neoplasms
Procedure: Moderate-intensity and low-intensity bodywork therapy
 
Patterson M, Maurer S, Adler SR, Avins AL. A novel clinical-trial design for the study of massage therapy. Complement Ther Med. 2008 Jun;16(3):169-76. Epub 2007 Sep 21.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
45
March 2004
 

Inclusion criteria:

  • Confirmed tissue diagnosis of cancer of the breast, ovary, prostate or colo-rectum
  • Have an anticipated completion of chemotherapy no more than 2 weeks before the last bodywork session.
  • Have a primary oncologist
  • Currently receiving chemotherapy or completed chemotherapy treatment within the past 6 months

Exclusion criteria:

  • Active skin rash or open cutaneous lesions.
  • History of venous thrombosis (or symptomatic varicosity)
  • Identification of a thrombosis using an ultrasound test of the legs.
  • Long term (> 3 months) steroid medications for other medical conditions in past 5 years
  • Plans to move out of the study region within 6 months
  • Thyroid-stimulating hormone (TSH) level above the upper limit of normal
  • Hematocrit <25%
  • Platelet count of < 50,000
  • Patients who have been receiving regular (i.e. at least twice a month) bodywork over the past 6 months.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00039793
 
R21 AT000348-01
National Center for Complementary and Alternative Medicine (NCCAM)
 
Principal Investigator: Andrew Avins, MD, MPH Osher Center for Integrative Medicine, University of California, San Francisco
Investigator: Shelley Adler, PhD Osher Center for Integrative Medicine, University of California, San Francisco
Investigator: Michael Patterson, MS Osher Center for Integrative Medicine, University of California, San Francisco
National Center for Complementary and Alternative Medicine (NCCAM)
July 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP