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.

Condition	Treatment or Intervention	Phase
Breast Neoplasms Ovarian Neoplasms Prostatic Neoplasms Colorectal Neoplasms	Procedure: Moderate-intensity and low-intensity bodywork therapy	Phase II

Further Study Details: 

Expected Total Enrollment:  45

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

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.

California
      Osher Center for Integrative Medicine, San Francisco,  California,  94143,  United States

Study chairs or principal investigators

Andrew Avins, MD, MPH,  Principal Investigator,  Osher Center for Integrative Medicine, University of California, San Francisco   
Shelley Adler, PhD,  Osher Center for Integrative Medicine, University of California, San Francisco   
Michael Patterson, MS,  Osher Center for Integrative Medicine, University of California, San Francisco   

Study ID Numbers:  1 R21 AT00348-01
Record last reviewed:  September 2004
Last Updated:  October 13, 2004
Record first received:  June 11, 2002
ClinicalTrials.gov Identifier:  NCT00039793
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08