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Brief Title: Massage for Prostate Cancer-Related Fatigue, mPROSTATE Study
Official Title: Massage for Prostate Cancer-Related Fatigue
Study ID: NCT05067777
Brief Summary: This phase II trial investigates the effect of massage in decreasing prostate cancer-related fatigue. Massage therapy has well known health benefits. This trial aims to find out if massage and touch therapies reduce fatigue due to cancer, and to learn if these therapies are better than traditional medicine or psychology for cancer related fatigue.
Detailed Description: PRIMARY OBJECTIVE: I. To conduct a preliminary study to evaluate whether a 6-week Swedish Massage Therapy (SMT) intervention decreases cancer-related fatigue (CRF) significantly more than Light Touch (LT) or Wait List Control (WLC) among prostate cancer (PCa) survivors who have received both radiation and androgen deprivation therapy. SECONDARY OBJECTIVE: I. To evaluate whether the hypothesized decrease in cancer-related fatigue with SMT is associated with modulation of specific immune system factors underlying chronic inflammation. EXPLORATORY OBJECTIVES: I. To evaluate whether SMT improves self-reported fatigue, quality of life, depression, and anxiety significantly more than LT or WLC. II. To gather preliminary data about the sustained actions of 6 weeks of SMT versus LT on CRF, at 6 and 12 weeks after the intervention. OUTLINE: Patients are randomized to 1 of 3 arms. Arm I: Patients receive SMT over 45 minutes once weekly for 6 weeks. Arm II: Patients receive LT over 45 minutes once weekly for 6 weeks. Arm III: Patients receive no intervention for 6 weeks. After completion of study, patients are followed up at 12 and 18 weeks.
Minimum Age: 45 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Huntsman Cancer Institute/University of Utah, Salt Lake City, Utah, United States
Name: Mark H Rapaport
Affiliation: Huntsman Cancer Institute/ University of Utah
Role: PRINCIPAL_INVESTIGATOR