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Massage Therapy for Cancer-Related Fatigue

Primary Purpose

Breast Neoplasms, Ovarian Neoplasms, Prostatic Neoplasms

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Moderate-intensity and low-intensity bodywork therapy
Sponsored by
National Center for Complementary and Integrative Health (NCCIH)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Neoplasms focused on measuring Cancer-related fatigue, alternative medicine, cancer rehabilitation /care, fatigue, human therapy evaluation, physical therapy, neoplasm /cancer chemotherapy, neoplasm /cancer palliative treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Osher Center for Integrative Medicine

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 11, 2002
Last Updated
August 17, 2006
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00039793
Brief Title
Massage Therapy for Cancer-Related Fatigue
Official Title
Massage Therapy for Cancer-Related Fatigue
Study Type
Interventional

2. Study Status

Record Verification Date
July 2006
Overall Recruitment Status
Completed
Study Start Date
March 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms, Ovarian Neoplasms, Prostatic Neoplasms, Colorectal Neoplasms
Keywords
Cancer-related fatigue, alternative medicine, cancer rehabilitation /care, fatigue, human therapy evaluation, physical therapy, neoplasm /cancer chemotherapy, neoplasm /cancer palliative treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Moderate-intensity and low-intensity bodywork therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Avins, MD, MPH
Organizational Affiliation
Osher Center for Integrative Medicine, University of California, San Francisco
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shelley Adler, PhD
Organizational Affiliation
Osher Center for Integrative Medicine, University of California, San Francisco
First Name & Middle Initial & Last Name & Degree
Michael Patterson, MS
Organizational Affiliation
Osher Center for Integrative Medicine, University of California, San Francisco
Facility Information:
Facility Name
Osher Center for Integrative Medicine
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18534330
Citation
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. doi: 10.1016/j.ctim.2007.08.001. Epub 2007 Sep 21.
Results Reference
derived
Links:
URL
http://www.ucsf.edu/ocim/
Description
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Massage Therapy for Cancer-Related Fatigue

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