Massage for Prostate Cancer-Related Fatigue, mPROSTATE Study (mPROSTATE)

This is an interventional treatment trial for Prostate Carcinoma Read More

Inclusion Criteria:

• Male subjects aged >= 45 years old
• Histologically confirmed diagnosis of prostate cancer
• Subjects must have completed radiation therapy >= 2 months, but =< 6 years prior to registration
• Subjects undergoing androgen depravation therapy with serum testosterone levels < 20 ng/ml
• 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 (TSH) greater than 4.6 micro-international units (uIU)/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 supine for one hour at a time, given the nature of the massage intervention
• Body-mass index less than 18.5 (kg/m^2)
• Treatment with corticosteroids or other immunosuppressants =< 6 months prior to registration
• Subjects who have completed radiation >= 6 years prior to registration
• 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
• Use of medications for anxiety or depression =< 4 weeks prior to registration. (psychotropic drug free for at least 4 weeks - 8 weeks for fluoxetine)
• Use of fluoxetine 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
• Subjects who have used massage as a therapeutic modality (medical or psychological) for the treatment of medical conditions
• Subjects who have had 4 or more massages a year for the last 5 years

• Current use of complementary or alternative medicine (CAM) manual therapy and/or holistic therapies to treat a perceived health problem.

  • Subjects who have engaged in a CAM manual therapy in the past will not be excluded.
  • Subjects who practice yoga or meditation for well-being, take vitamins, or use nicotine will not be excluded
• 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