Breast Neoplasms, Colorectal Neoplasms, Ovarian Neoplasms, Prostatic Neoplasms
Conditions
Keywords
Cancer-related fatigue, alternative medicine, cancer rehabilitation /care, fatigue, human therapy evaluation, physical therapy, neoplasm /cancer chemotherapy, neoplasm /cancer palliative 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.
Interventions
PROCEDUREModerate-intensity and low-intensity bodywork therapy
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Countries
United States
Outcome results
None listed