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Sponsored by: |
National Center for Complementary and Alternative Medicine (NCCAM) |
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Information provided by: | National Center for Complementary and Alternative Medicine (NCCAM) |
ClinicalTrials.gov Identifier: | NCT00039793 |
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 | Intervention | Phase |
---|---|---|
Breast Neoplasms Ovarian Neoplasms Prostatic Neoplasms Colorectal Neoplasms |
Procedure: Moderate-intensity and low-intensity bodywork therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Massage Therapy for Cancer-Related Fatigue |
Estimated Enrollment: | 45 |
Study Start Date: | March 2001 |
Estimated Study Completion Date: | March 2004 |
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 older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
United States, California | |
Osher Center for Integrative Medicine | |
San Francisco, California, United States, 94143 |
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 |
Study ID Numbers: | R21 AT000348-01 |
Study First Received: | June 11, 2002 |
Last Updated: | August 17, 2006 |
ClinicalTrials.gov Identifier: | NCT00039793 History of Changes |
Health Authority: | United States: Federal Government |
Cancer-related fatigue alternative medicine cancer rehabilitation /care fatigue |
human therapy evaluation physical therapy neoplasm /cancer chemotherapy neoplasm /cancer palliative treatment |
Prostatic Diseases Genital Neoplasms, Male Gastrointestinal Diseases Gonadal Disorders Colonic Diseases Urogenital Neoplasms Ovarian Diseases Rectal Diseases Genital Diseases, Female Signs and Symptoms Ovarian Cancer Breast Diseases Endocrine Gland Neoplasms Digestive System Neoplasms |
Fatigue Ovarian Neoplasms Skin Diseases Genital Neoplasms, Female Breast Neoplasms Endocrine System Diseases Intestinal Diseases Genital Diseases, Male Intestinal Neoplasms Digestive System Diseases Gastrointestinal Neoplasms Endocrinopathy Prostatic Neoplasms Colorectal Neoplasms |
Prostatic Diseases Genital Neoplasms, Male Gonadal Disorders Gastrointestinal Diseases Colonic Diseases Urogenital Neoplasms Ovarian Diseases Rectal Diseases Genital Diseases, Female Signs and Symptoms Neoplasms by Site Breast Diseases Endocrine Gland Neoplasms Digestive System Neoplasms Ovarian Neoplasms |
Fatigue Skin Diseases Genital Neoplasms, Female Breast Neoplasms Endocrine System Diseases Genital Diseases, Male Intestinal Diseases Intestinal Neoplasms Adnexal Diseases Neoplasms Digestive System Diseases Gastrointestinal Neoplasms Prostatic Neoplasms Colorectal Neoplasms |