Breast Cancer Clinical Trial

Massage Therapy for Cancer-Related Fatigue

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.

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Full 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.

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Eligibility 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.

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

45

Study ID:

NCT00039793

Recruitment Status:

Completed

Sponsor:

National Center for Complementary and Integrative Health (NCCIH)

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There is 1 Location for this study

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

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

45

Study ID:

NCT00039793

Recruitment Status:

Completed

Sponsor:


National Center for Complementary and Integrative Health (NCCIH)

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