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Massage Therapy for Cancer-Related Fatigue


Phase 2
18 Years
N/A
Not Enrolling
Both
Breast Neoplasms, Ovarian Neoplasms, Prostatic Neoplasms, Colorectal Neoplasms

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Trial Information

Massage Therapy for Cancer-Related Fatigue


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.

Inclusion 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.

Type of Study:

Interventional

Study Design:

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

Principal Investigator

Andrew Avins, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

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

Authority:

United States: Federal Government

Study ID:

R21 AT000348-01

NCT ID:

NCT00039793

Start Date:

March 2001

Completion Date:

March 2004

Related Keywords:

  • Breast Neoplasms
  • Ovarian Neoplasms
  • Prostatic Neoplasms
  • Colorectal Neoplasms
  • Cancer-related fatigue
  • alternative medicine
  • cancer rehabilitation /care
  • fatigue
  • human therapy evaluation
  • physical therapy
  • neoplasm /cancer chemotherapy
  • neoplasm /cancer palliative treatment
  • Breast Neoplasms
  • Neoplasms
  • Colorectal Neoplasms
  • Fatigue
  • Ovarian Neoplasms
  • Prostatic Neoplasms

Name

Location

Osher Center for Integrative Medicine San Francisco, California  94143