Massage therapy for fatigue in prostate cancer survivors

Massage for Prostate Cancer-Related Fatigue

This study tests if Swedish Massage Therapy can help reduce fatigue and improve quality of life for prostate cancer survivors who have had radiation and hormone therapy.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 57 (estimated)
• Ages: 45 Years and up
• Sex: Male
• Sponsor: University of Utah (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Salt Lake City, Utah)
• Trial ID: NCT05067777 on ClinicalTrials.gov

What this trial studies

This phase II trial investigates the effectiveness of Swedish Massage Therapy (SMT) in reducing cancer-related fatigue among prostate cancer survivors who have undergone radiation and androgen deprivation therapy. Participants are randomized into three groups: one receiving SMT, another receiving light touch therapy, and a control group with no intervention. The study aims to evaluate not only the reduction in fatigue but also the potential impact on quality of life, depression, and anxiety. Additionally, it seeks to understand the relationship between massage therapy and immune system factors related to chronic inflammation.

Who should consider this trial

Good fit: Ideal candidates are male prostate cancer survivors aged 45 and older who have completed radiation therapy and are undergoing androgen deprivation therapy.

Not a fit: Patients with significant comorbid psychiatric disorders, anemia, uncontrolled pain, or other medical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a non-pharmacological approach to alleviate fatigue in prostate cancer survivors.

How similar studies have performed: Other studies have shown promising results with massage therapy for cancer-related fatigue, suggesting potential for success in this approach.

Eligibility criteria

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 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)
* 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

Where this trial is running

Salt Lake City, Utah

• Huntsman Cancer Institute/University of Utah — Salt Lake City, Utah, United States (Recruiting)

Study contacts

• Principal investigator: Mark H Rapaport — Huntsman Cancer Institute/ University of Utah
• Study coordinator: Susan Sharry

Conditions Prostate Carcinoma