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Massage Therapy for Cancer-Related Fatigue

NCT ID: NCT00039793

Last Updated: 2006-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-03-31

Study Completion Date

2004-03-31

Brief Summary

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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

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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.

Conditions

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Breast Neoplasms Ovarian Neoplasms Prostatic Neoplasms Colorectal Neoplasms

Keywords

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Cancer-related fatigue alternative medicine cancer rehabilitation /care fatigue human therapy evaluation physical therapy neoplasm /cancer chemotherapy neoplasm /cancer palliative treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Moderate-intensity and low-intensity bodywork therapy

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role lead

Principal Investigators

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Andrew Avins, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Osher Center for Integrative Medicine, University of California, San Francisco

Shelley Adler, PhD

Role:

Osher Center for Integrative Medicine, University of California, San Francisco

Michael Patterson, MS

Role:

Osher Center for Integrative Medicine, University of California, San Francisco

Locations

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Osher Center for Integrative Medicine

San Francisco, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 18534330 (View on PubMed)

Related Links

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http://www.ucsf.edu/ocim/

Click here for more information about how to contact this study

Other Identifiers

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R21AT000348-01

Identifier Type: NIH

Identifier Source: org_study_id

View Link

NCT00058513

Identifier Type: -

Identifier Source: nct_alias