|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Tracking Information | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | June 11, 2002 | ||||||||||||
| Last Updated Date | August 17, 2006 | ||||||||||||
| Start Date ICMJE | March 2001 | ||||||||||||
| Primary Completion Date | |||||||||||||
| Current Primary Outcome Measures ICMJE | |||||||||||||
| Original Primary Outcome Measures ICMJE | |||||||||||||
| Change History | Complete list of historical versions of study NCT00039793 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | Massage Therapy for Cancer-Related Fatigue | ||||||||||||
| Official Title ICMJE | Massage Therapy for Cancer-Related Fatigue | ||||||||||||
| 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. |
||||||||||||
| 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 Phase | Phase II | ||||||||||||
| Study Type ICMJE | Interventional | ||||||||||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||||||||||
| Condition ICMJE |
|
||||||||||||
| Intervention ICMJE | Procedure: Moderate-intensity and low-intensity bodywork therapy | ||||||||||||
| Study Arms / Comparison Groups | |||||||||||||
| Publications * | Patterson M, Maurer S, Adler SR, Avins AL. A novel clinical-trial design for the study of massage therapy. Complement Ther Med. 2008 Jun;16(3):169-76. Epub 2007 Sep 21. | ||||||||||||
|
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||||||||||
| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Completed | ||||||||||||
| Enrollment ICMJE | 45 | ||||||||||||
| Completion Date | March 2004 | ||||||||||||
| Primary Completion Date | |||||||||||||
| Eligibility Criteria ICMJE | Inclusion criteria:
Exclusion criteria:
|
||||||||||||
| Gender | Both | ||||||||||||
| Ages | 18 Years and older | ||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
| Location Countries ICMJE | United States | ||||||||||||
| Administrative Information | |||||||||||||
| NCT ID ICMJE | NCT00039793 | ||||||||||||
| Responsible Party | |||||||||||||
| Study ID Numbers ICMJE | R21 AT000348-01 | ||||||||||||
| Study Sponsor ICMJE | National Center for Complementary and Alternative Medicine (NCCAM) | ||||||||||||
| Collaborators ICMJE | |||||||||||||
| Investigators ICMJE |
|
||||||||||||
| Information Provided By | National Center for Complementary and Alternative Medicine (NCCAM) | ||||||||||||
| Verification Date | July 2006 | ||||||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||||||