Massage for Prostate Cancer-Related Fatigue, mPROSTATE Study

Inclusion Criteria

• Male subjects aged >= 45 years old
• Histologically confirmed diagnosis of prostate cancer
• Subjects must have completed radiation therapy >= 2 months prior to registration
• Subjects who have a score > 25 on the Brief Fatigue Inventory (BFI) at screening
• Subjects who are fluent in speaking and reading English
• Based on International Classification of Diseases (ICD)-10 proposed criteria, the patient must have a diagnosis of CRF with evidence from the history, physical exam, and laboratory findings that the fatigue is a consequence of cancer or cancer therapy and not primarily a consequence of any of the following: * Comorbid psychiatric disorders * Anemia (hemoglobin less than 10 g/dl) * Hypothyroidism (thyroid stimulating hormone greater than 4.6 MCU/mL) * Uncontrolled pain * Any medical or psychiatric condition or medication felt to be clinically contributing to fatigue based on the investigator’s history, physical examination, and assessment. These medical circumstances may include: ** The use of medications such as opioids, sedating anti-histamines, or neuroleptics; ** Medical problems associated with fatigue: chronic obstructive pulmonary disease, congestive heart failure, renal disease, hepatic dysfunction, uncontrolled autoimmune disease, neurological disorders such as multiple sclerosis or Parkinson’s disease, and sleep apnea
• Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines

Exclusion Criteria

• Inability to lay prone comfortably for 25 minutes and inability to lay supine comfortably for 25 minutes, given the nature of the massage intervention
• Body-mass index less than 18.5 (kg/m^2)
• Current use of any medications or therapies listed as prohibited
• Treatment with corticosteroids or other immunosuppressants =< 6 months prior to registration, unless the medication is necessary to support patient wellbeing and unlikely to negatively impact study aims, per principal investigator (PI) judgement
• Subjects who cannot comply with the protocol for any reason
• Regular use of anti-inflammatory drugs including non-steroidal anti-inflammatory drugs and natural products thought to have anti-inflammatory properties, unless the medication is necessary to support patient wellbeing and unlikely to negatively impact study aims, per PI judgement
• Change in prescribed dose of medications for anxiety or depression =< 4 weeks prior to registration
• Change in fluoxetine dose within =< 8 weeks prior to registration
• Subjects meeting criteria for a current substance use diagnosis or current diagnoses of schizophrenia, depression, generalized anxiety disorder, bipolar disorder, dementia, delirium, or obsessive compulsive disorder (OCD)
• Subjects who are actively suicidal or homicidal
• Other conditions or behaviors that, in the opinion of the treating investigator, may negatively impact study participation, including the following: * Illicit drug use * Shift work * Current dieting * Excessive regular use of alcohol (more than two 5-ounce glasses of wine or equivalents/day) * Any instance of binge drinking (more than 7 drinks in a 24-hour period) =< 6 months prior to registration
• Current and/or past use of massage for the treatment of fatigue
• Medical, psychiatric, cognitive, or other conditions that may compromise the subject's ability to understand the subject information, give informed consent, comply with the study protocol, or complete the study