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Massage Therapy for Cancer-Related Fatigue Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Massage Therapy for Cancer-Related Fatigue conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Massage Therapy for Cancer-Related Fatigue Clinical research trials and Massage Therapy for Cancer-Related Fatigue healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Massage Therapy for Cancer-Related Fatigue. Massage Therapy for Cancer-Related Fatigue Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Massage Therapy for Cancer-Related Fatigue clinical trial. Human subjects often receive the most effective healthcare possible for their Massage Therapy for Cancer-Related Fatigue condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "M" Clinical Trials Conditions > Massage Therapy for Cancer-Related Fatigue  Massage Therapy for Cancer-Related Fatigue
Massage Therapy for Cancer-Related Fatigue
For Condition: Breast Neoplasms,Ovarian Neoplasms,Colorectal Neoplasms,Prostatic Neoplasms
Status: Recruiting
Sponsor(s): National Center for Complementary and Alternative Medicine (NCCAM) ,
Synopsis: 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.
Details: 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. Sixty patients with breast, ovarian, prostate, or colo-rectal cancer will be enrolled; the primary outcome measure is a quantitative assessment of fatigue symptoms. In addition to obtaining estimates of efficacy, this Exploratory/Developmental Research Grant (R21) application also proposes several research design innovations to address critical methodological issues that have plagued prior studies of complementary and alternative medicine (CAM) interventions in general, and bodywork therapies, in particular. 1) Current quantitative assessment tools often fail to fully capture the nature and degree of change in highly subjective conditions and their impact on an individual's functioning and quality of life. We propose to add a novel qualitative research component to study changes in participants' perceptions of fatigue severity and its impact on their lives. 2) Most prior studies in bodywork interventions have failed to adequately control for the non-specific effects of the time spent with a practitioner and physical contact between the provider and participant. We propose to test a unique control condition (in addition to a usual-care control arm) to account for these effects. 3) Prior studies of bodywork therapies have neglected important psychological and sociocultural factors associated with subjects' participation and outcomes. We will examine these issues within the qualitative research component. 4) Because bodywork involves close personal physical contact, gender issues may complicate the provision and success of massage therapy. We will study these effects using qualitative methods, as well as a stratified randomization of gender-concordant and gender-discordant pairs to examine outcomes. 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:
Study Type: Interventional, Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 45
Location and Contact Information:
Overall Study Official:
AndrewAvins, Principal Investigator, Osher Center for Integrative Medicine, University of California, San Francisco
Osher Center for Integrative Medicine *Recruiting*
San Francisco, California, 94143
United States
Recruiting
Additional Information:
Study ID Numbers: 1 R21 AT00348-01;
Study Start Date: March 2001
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00039793
Other Breast Neoplasms Studies:
1. Multicenter Clinical Trial of Intravenous OvaRex MAb-B43.13 as Post-chemotherapy Consolidation for Ovarian Carcinoma
2. A Safety and Effectiveness Study of Aroplatin in Patients with Advanced Solid Malignancies
3. Study of T900607-sodium in previously treated patients with ovarian cancer.
4. A Comparative Pharmacokinetics and Safety Study of OvaRex MAb-B43.13 in Patients with Ovarian Epithelial Carcinoma
5. Phase II Trial of Gleevec in Patients with Advanced Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
Related Studies:
Other Breast Neoplasms Clinical Trials
Other California Clinical Trials
Other San Francisco Clinical Trials
Massage Therapy for Cancer-Related Fatigue
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