Massage therapy tested as fatigue fix for prostate cancer survivors
NCT ID NCT05067777
First seen Jun 25, 2026 · Last updated Jul 14, 2026 · Updated 3 times
Summary
This phase II trial tested whether Swedish massage can reduce fatigue in men who have had radiation for prostate cancer. The study enrolled 28 men aged 45 and older who reported significant fatigue. Researchers measured fatigue levels and inflammatory markers before and after massage sessions. The trial was terminated early, so the findings are limited.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Swedish massage therapy
- What this could lead to
- If it works, this could point toward a drug-free way to ease cancer-related fatigue.
- What could go wrong
- The trial was terminated early and had only 28 participants, so results are limited. Fatigue is subjective and may not improve for everyone.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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28 people
The number who actually took part.
- Started
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Jun 2022
- Finished
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Aug 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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45 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 (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 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 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112, United States
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