Massage Therapy for Cancer-Related Fatigue

Breast Neoplasms Clinical Trial

Official title:

Massage Therapy for Cancer-Related Fatigue

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00039793
• Other study ID #: R21AT000348-01
• Status: Completed
• Phase: Phase 2
• First received: June 11, 2002
• Last updated: August 17, 2006
• Start date: March 2001
• Est. completion date: March 2004

Study information

• Verified date: July 2006
• Source: National Center for Complementary and Integrative Health (NCCIH)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00058513

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: March 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Colorectal Neoplasms
• Neoplasms
• Ovarian Neoplasms
• Prostatic Neoplasms

Intervention

Procedure:
• Moderate-intensity and low-intensity bodywork therapy

Locations

Country	Name	City	State
United States	Osher Center for Integrative Medicine	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

External Links

•   Click here for more information about how to contact this study