Clinical trial NCT00039793: Massage Therapy for Cancer-Related Fatigue
Official title: Massage Therapy for Cancer-Related Fatigue
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: 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
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2002-06-13
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Osher Center for Integrative Medicine
state: California
Study officials:
affiliation: Osher Center for Integrative Medicine, University of California, San Francisco
name: Andrew Avins, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Osher Center for Integrative Medicine, University of California, San Francisco
name: Shelley Adler, PhD
affiliation: Osher Center for Integrative Medicine, University of California, San Francisco
name: Michael Patterson, MS
References:
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.