Massage for Prostate Cancer-Related Fatigue, mPROSTATE Study

Description

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.

Conditions

Prostate Carcinoma

Study Overview

Study Details

Study overview

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.

Massage for Prostate Cancer-Related Fatigue

Massage for Prostate Cancer-Related Fatigue, mPROSTATE Study

Condition
Prostate Carcinoma
Intervention / Treatment

-

Contacts and Locations

Salt Lake City

Huntsman Cancer Institute/University of Utah, Salt Lake City, Utah, United States, 84112

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 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
  • * 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)
  • * Current use of any medications or therapies listed as prohibited in Section 6.6.1.
  • * 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 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

Ages Eligible for Study

45 Years to

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Utah,

Mark H Rapaport, PRINCIPAL_INVESTIGATOR, Huntsman Cancer Institute/ University of Utah

Study Record Dates

2027-10-30