Massage Therapy for Cancer-Related Fatigue

This study has been completed.
Sponsor:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00039793
First received: June 11, 2002
Last updated: August 17, 2006
Last verified: July 2006
  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

Resource links provided by NLM:


Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Estimated Enrollment: 45
Study Start Date: March 2001
Estimated Study Completion Date: March 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00039793

Locations
United States, California
Osher Center for Integrative Medicine
San Francisco, California, United States, 94143
Sponsors and Collaborators
Investigators
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:
Neoplasms
Fatigue
Breast Neoplasms
Colorectal Neoplasms
Prostatic Neoplasms
Ovarian Neoplasms
Signs and Symptoms
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
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on September 22, 2014