Massage Therapy for Cancer-Related Fatigue

Sponsor

National Center for Complementary and Integrative Health (NCCIH) (NIH)

Overall Status

Completed

CT.gov ID

NCT00039793

Collaborator

(none)

Enrollment

Location

Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Breast Neoplasms Ovarian Neoplasms Prostatic Neoplasms Colorectal Neoplasms	Procedure: Moderate-intensity and low-intensity bodywork therapy	Phase 2

Detailed Description

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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Massage Therapy for Cancer-Related Fatigue

Study Start Date :

Mar 1, 2001

Study Completion Date :

Mar 1, 2004

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Osher Center for Integrative Medicine	San Francisco	California	United States	94143

Sponsors and Collaborators

National Center for Complementary and Integrative Health (NCCIH)

Investigators

Principal Investigator: Andrew Avins, MD, MPH, 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