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

December 9, 2025 updated by: University of Utah
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

With over 15.5 million cancer survivors today in the United States, increased attention is being given to quality of life (QOL) after cancer treatment. Cancer-related fatigue (CRF), "a persistent, subjective sense of physical, emotional, and/or cognitive exhaustion related to cancer or its treatment that is not proportional to recent activity" (National Comprehensive Cancer Network, accessed Oct2020), is the most common and one of the most devastating symptoms among patients with cancer. CRF occurs across the spectrum of cancer types and treatments and has a negative impact on all areas of function, including mood, physical function, work performance, social interaction, family care, cognitive performance, schoolwork, and community activities. CRF can persist for months or years after cancer therapy is completed. CRF has been designated a high-priority research area by the National Cancer Institute (NCI) and is 1 of the 5 highest-priority research areas designated by the NCI Clinical Oncology Research.

This study is a phase II, 3-arm, randomized comparison of single-blinded once-weekly Swedish Massage Therapy (SMT) vs. Light Touch (LT) Control vs. unblinded waitlist control (WLC) for 6 weeks. We chose once-a-week sessions for 6 weeks to match the length of our completed National Center for Complementary and Integrative Health (NCCIH) trial of SMT vs. LT for breast cancer survivors with CRF.

Subjects who complete SMT or LT will be interviewed in person, by telemedicine, or by telephone at 6 and 12 weeks after the last study visit in order to evaluate the sustained effects of SMT and LT. We hypothesize that SMT will have a clinically meaningful benefit in improving fatigue, mood, and quality of life (QOL) in Prostate Cancer (PCa) patients, and that this will correlate with favorable changes in physiological parameters that may underlie CRF. Demographic, medical, clinical, and biological characteristics will be compared between groups of subjects randomized to SMT, LT, or WLC. Any treatment group differences in PCa grade and time since completion of radiation therapy, or baseline Brief Fatigue Inventory (BFI) fatigue score, may affect treatment-related change in fatigue or biological measures related to inflammation, or the post-treatment duration of benefit. While groups are expected to be similar on these characteristics, any variable with a p ≤ 0.10 difference between groups will be considered as a candidate covariate or stratification variable for statistical tests of the study hypotheses.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

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.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Swedish Massage Therapy (SMT)
Patients receive SMT over 45 minutes once weekly for 6 weeks.
Procedure: Swedish Massage Therapy (SMT)
The therapist uses non-aromatic cream to facilitate making long strokes over the body. Swedish massage is done with the subject covered by a sheet, a technique called "draping." One part of the body is uncovered, massaged, and then re-draped before moving to another part. The primary techniques used in the research protocol therapy are effleurage, petrissage, kneading, tapotement and thumb friction. These techniques are performed in a very precise, carefully elaborated manner. The session starts with the subject fully draped in a prone position on the massage table and after approximately 22 minutes the subject is instructed to turn to the supine position. Finally, the therapist moves to the head area of the subject, begins working on the shoulders, neck and head using effleurage and thumb friction, and concludes by using light tapotement on the head. The total time for the entire massage is 45 minutes.
Other Names:
  • Massage
  • massage therapy
Sham Comparator: Light Touch (LT)
Patients receive LT over 45 minutes once weekly for 6 weeks.
Procedure: Light Touch (LT) Control
The protocol entails the same duration and sequence of procedures as the massage protocol, except that the therapist employs only light-touch hand placement on the subject's body. This condition isolates the effect of the mechanical intervention of SMT.
Active Comparator: Waitlist Control (WLC)
Patients will sit and relax for 45 minutes before completing study assessments at weeks 3 and 6.
Other: Waitlist Control (WLC)
Subjects randomized to WLC will sit and relax for 45 minutes.
Other Names:
  • Sham Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in cancer-related fatigue
Time Frame: up to 6 weeks from the initiation of study intervention

Multidimensional Fatigue Inventory (MFI)-20 is a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Participants rate each item on a 5-point Likert scale from 1 "yes, that is true" to 5 "no, that is not true".

This outcome measure will report 5 subscales (General Fatigue, Physical Fatigue, Reduced Activity, Reduced Motivation, Mental Fatigue) and the Total Raw Score. All scores range from 1-5, with higher scores indicating more fatigue and lower scores indicating less fatigue.
up to 6 weeks from the initiation of study intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in plasma concentrations of pre-inflammatory cytokine IL-1beta
Time Frame: up to 6 weeks from the initiation of study intervention

To evaluate whether the hypothesized decrease in cancer-related fatigue with SMT is associated with modulation of specific immune system factors underlying chronic inflammation.

This outcome measure will report the mean change in plasma concentrations of pre-inflammatory cytokine IL-1beta from baseline to 6 weeks after initiation of the study intervention.

Further statistical analysis will assess the association between the change in IL-1beta and MFI scores.
up to 6 weeks from the initiation of study intervention
Change in plasma concentrations of pre-inflammatory cytokine IL-1Ra
Time Frame: up to 6 weeks from the initiation of study intervention

To evaluate whether the hypothesized decrease in cancer-related fatigue with SMT is associated with modulation of specific immune system factors underlying chronic inflammation.

This outcome measure will report the mean change in plasma concentrations of pre-inflammatory cytokine IL-1Ra from baseline to 6 weeks after initiation of the study intervention.

Further statistical analysis will assess the association between the change in cytokine IL-1Ra and MFI scores.
up to 6 weeks from the initiation of study intervention
Change in plasma concentrations of pre-inflammatory cytokine IL-6
Time Frame: up to 6 weeks from the initiation of study intervention

To evaluate whether the hypothesized decrease in cancer-related fatigue with SMT is associated with modulation of specific immune system factors underlying chronic inflammation.

This outcome measure will report the mean change in plasma concentrations of pre-inflammatory cytokine IL-6 from baseline to 6 weeks after initiation of the study intervention.

Further statistical analysis will assess the association between the change in cytokine IL-6 and MFI scores.
up to 6 weeks from the initiation of study intervention
Change in plasma concentrations of pre-inflammatory cytokine sIL-6R
Time Frame: up to 6 weeks from the initiation of study intervention

To evaluate whether the hypothesized decrease in cancer-related fatigue with SMT is associated with modulation of specific immune system factors underlying chronic inflammation.

This outcome measure will report the mean change in plasma concentrations of pre-inflammatory cytokine sIL-6R from baseline to 6 weeks after initiation of the study intervention.

Further statistical analysis will assess the association between the change in cytokine sIL-6R and MFI scores.
up to 6 weeks from the initiation of study intervention
Change in plasma concentrations of pre-inflammatory cytokine TNF-α
Time Frame: up to 6 weeks from the initiation of study intervention

To evaluate whether the hypothesized decrease in cancer-related fatigue with SMT is associated with modulation of specific immune system factors underlying chronic inflammation.

This outcome measure will report the mean change in plasma concentrations of pre-inflammatory cytokine TNF-α from baseline to 6 weeks after initiation of the study intervention.

Further statistical analysis will assess the association between the change in cytokine TNF-α and MFI scores.
up to 6 weeks from the initiation of study intervention
Change in plasma concentrations of pre-inflammatory cytokine sTNFR2
Time Frame: up to 6 weeks from the initiation of study intervention

To evaluate whether the hypothesized decrease in cancer-related fatigue with SMT is associated with modulation of specific immune system factors underlying chronic inflammation.

This outcome measure will report the mean change in plasma concentrations of pre-inflammatory cytokine sTNFR2 from baseline to 6 weeks after initiation of the study intervention.

Further statistical analysis will assess the association between the change in cytokine sTNFR2 and MFI scores.
up to 6 weeks from the initiation of study intervention
Change in plasma concentrations of pre-inflammatory cytokine IFN-γ
Time Frame: up to 6 weeks from the initiation of study intervention

To evaluate whether the hypothesized decrease in cancer-related fatigue with SMT is associated with modulation of specific immune system factors underlying chronic inflammation.

This outcome measure will report the mean change in plasma concentrations of pre-inflammatory cytokine IFN-γ from baseline to 6 weeks after initiation of the study intervention.

Further statistical analysis will assess the association between the change in cytokine IFN-γ and MFI scores.
up to 6 weeks from the initiation of study intervention
Change in plasma concentrations of High-Sensitivity C-Reactive Protein (hsCRP)
Time Frame: up to 6 weeks from the initiation of study intervention

To evaluate whether the hypothesized decrease in cancer-related fatigue with SMT is associated with modulation of specific immune system factors underlying chronic inflammation.

This outcome measure will report the mean change in plasma concentrations of hsCRP from baseline to 6 weeks after initiation of the study intervention.

Further statistical analysis will assess the association between the change in hsCRP and MFI scores.
up to 6 weeks from the initiation of study intervention
Change in plasma concentrations of anti-inflammatory cytokine IL-10
Time Frame: up to 6 weeks from the initiation of study intervention

To evaluate whether the hypothesized decrease in cancer-related fatigue with SMT is associated with modulation of specific immune system factors underlying chronic inflammation.

This outcome measure will report the mean change in plasma concentrations of anti-inflammatory cytokine IL-10 from baseline to 6 weeks after initiation of the study intervention.

Further statistical analysis will assess the association between the change in anti-inflammatory cytokine IL-10 and MFI scores.
up to 6 weeks from the initiation of study intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Mark H Rapaport, Huntsman Cancer Institute/ University of Utah

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 17, 2022

Primary Completion (Actual)

August 2, 2025

Study Completion (Actual)

August 2, 2025

Study Registration Dates

First Submitted

September 17, 2021

First Submitted That Met QC Criteria

September 23, 2021

First Posted (Actual)

October 5, 2021

Study Record Updates

Last Update Posted (Estimated)

December 15, 2025

Last Update Submitted That Met QC Criteria

December 9, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCI144295 (Other Identifier: Huntsman Cancer Institute/University of Utah)
  • P30CA042014 (U.S. NIH Grant/Contract)
  • NCI-2021-09613 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • R21CA263453 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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