Massage Therapy for Cancer-Related Fatigue
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Purpose
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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| 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 |
More Information
No publications provided by National Center for Complementary and Alternative Medicine (NCCAM)
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00039793 History of Changes |
| Obsolete Identifiers: | NCT00058513 |
| Other Study ID Numbers: | R21 AT000348-01 |
| Study First Received: | June 11, 2002 |
| Last Updated: | August 17, 2006 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
|
Cancer-related fatigue alternative medicine cancer rehabilitation /care fatigue |
human therapy evaluation physical therapy neoplasm /cancer chemotherapy neoplasm /cancer palliative treatment |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms Colorectal Neoplasms Fatigue Ovarian Neoplasms Prostatic Neoplasms Neoplasms by Site Breast Diseases Skin Diseases Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases |
Intestinal Diseases Rectal Diseases Signs and Symptoms Endocrine Gland Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Genital Neoplasms, Male Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on May 22, 2013