Pain is not only a pervasive cancer symptom, but also the symptom reported by patients to cause greatest distress. It is particularly prevalent in advanced and end-stage disease. While there are many effective treatments for cancer-related pain, most notably opiate medication, a significant number of patients experience moderate or severe pain despite best management efforts. Current National Comprehensive Cancer Network guidelines for cancer pain recommend consideration of massage as an ancillary treatment for persisting distress. However, there are few high quality studies of massage for cancer-related pain, particularly in late stage and end-of-life populations. In preliminary studies at MSKCC, massage appears to be highly effective for pain, in the short term at least. In a series of over 400 patients with moderate to severe pain seen by massage practitioners at MSKCC, pain scores were reduced by an average of 57 percent immediately following treatment. OBJECTIVES: We plan to conduct a randomized Phase III study of massage for pain in advanced cancer. In this proposal, we plan to pilot such a study in order to whether a larger trial is warranted, and if so, to provide data to aid study design. METHODS: This randomized-study will test the ability of massage to reduce pain, comparing massage with two control groups: sham therapeutic touch or quiet time. Sixty patients with advanced cancer and pain greater than 3 on a 0-10 scale will be accrued. Patients will complete baseline pain and mood evaluation scales and will then be randomized to three 20-minute treatments of back massage daily, or to sham therapeutic touch or quiet time. Pain will be reassessed six times a day and mood scores once a day for six days. We will move to a Phase III study if at least 75 percent of patients provide evaluable data, if accrual is sufficiently rapid so that, after suitable sample size calculations, a controlled trial could be completed in less than two years, and if the 95 percent confidence interval for the difference between group means includes at least a 20 percent lower mean post-treatment pain score on massage than sham treatment
