Massage Therapy/Fatigue During Chemotherapy

11/03 Massage Therapy in Treating Fatigue in Patients Receiving Chemotherapy for Cancer Sponsored by Osher Center for Integrative Medicine at UCSF

Location

San Francisco, California, United States

RATIONALE: Massage may help relieve fatigue associated with chemotherapy.

PURPOSE: Randomized pilot study of massage therapy in treating fatigue in patients who are receiving chemotherapy for breast, ovarian, prostate, colon, or rectal cancer. Description

OBJECTIVES: Compare the efficacy of medium-intensity massage therapy vs passive bodywork/relaxation vs standard care in reducing symptoms of fatigue in patients with breast, ovarian, prostate, or colorectal cancer who are undergoing chemotherapy.

Compare the impact of gender differences on the perceptions and experiences of patients treated with these therapies.

Compare the clinical outcomes in patients treated with these therapies. Determine whether passive bodywork/relaxation can be used as an effective control condition in these patients.

Compare the quality of life of patients treated with these therapies.

OUTLINE: This is a randomized study. Patients are randomized to 1 of 3 treatment arms.

Arm I: Patients receive Swedish-style massage therapy (medium-intensity bodywork) over 50 minutes once or twice weekly for a total of 12 sessions.

Arm II: Patients receive passive bodywork and relaxation (low-intensity bodywork) over 50 minutes once or twice weekly for a total of 12 sessions.

Arm III: Patients receive standard care for fatigue. Quality of life and fatigue are assessed at baseline, before and after each bodywork session, and at 6 and 12 weeks.

PROJECTED ACCRUAL: A total of 45 patients (15 patients per treatment arm) will be accrued for this study.

Eligibility Criteria

DISEASE CHARACTERISTICS: Histologically confirmed cancer of 1 of the following sites: Breast Ovary Prostate Colon Rectum Planning to complete chemotherapy no more than 2 weeks before the last study bodywork session Schwartz Fatigue Scale score at least 14 Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age 18 and over Sex Male or female Menopausal status Not specified Performance status Karnofsky 80-100% Life expectancy Not specified Hematopoietic Hematocrit at least 25% Platelet count at least 50,000/mm^3 Hepatic Not specified Renal Not specified Cardiovascular No history of thrombosis or symptomatic varicosity No concurrent thrombosis by leg ultrasound

Other Thyroid-stimulating hormone at least lower limit of normal

No skin conditions (e.g., rashes or open lesions) Able to read, write, and understand English Planning to live in study region for 6 months

PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent bone marrow transplantation

Chemotherapy See Disease Characteristics

Endocrine therapy No long-term (more than 3 months) use of steroids for other medical conditions within the past 5 years

Radiotherapy Not specified

Surgery Not specified Other No regular bodywork (at least twice a month) over the past 6 months

Location and CONTACT INFORMATION Stephanie Maurer, M.A. 415-353-7912 maurers@ocim.ucsf.edu

California Osher Center for Integrative Medicine, San Francisco, California, 94143, United States; Recruiting

Study chairs or principal investigators

Andrew Avins, MD, MPH, Principal Investigator, Osher Center for Integrative Medicine, University of California, San Francisco Shelley Adler, Ph.D., Osher Center for Integrative Medicine, University of California, San Francisco Michael Patterson, M.S., Osher Center for Integrative Medicine, University of California, San Francisco More Information

Click here for more information about how to contact this study

Study ID Numbers 1 R21 AT00348-01 Study Start Date March 2001; Estimated Completion Date March 2004 Record last reviewed November 2003 NLM Identifier NCT00039793

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