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Prostate CarcinomaPhase 2mPROSTATENCT05067777

Massage for Prostate Cancer-Related Fatigue (mPROSTATE)

A Phase 2 study testing Swedish Massage Therapy (SMT) in people with Prostate Carcinoma, run by University of Utah at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 45 years and older, men only
Conditions the study is for
Prostate Carcinoma
What is being tested?
Swedish Massage Therapy (SMT)
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
28 participants
Where
1 siteUnited States
Study dates
17 Jun 2022to 2 Aug 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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

Who cannot join

  • 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.
Show all 18Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Huntsman Cancer Institute/University of Utah

    Salt Lake City, Utah, 84112

Other trials in United States

About this study

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.

Read the 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.

Being tested
Swedish Massage Therapy (SMT), Light Touch (LT) Control, Waitlist Control (WLC)
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Swedish Massage Therapy (SMT)Procedure or surgery

    Also called Massage, massage therapy

    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.

  • Light Touch (LT) ControlProcedure or surgery

    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.

  • Waitlist Control (WLC)Other

    Also called Sham Intervention

    Subjects randomized to WLC will sit and relax for 45 minutes.

Study groups in NCT05067777
Study groupRoleWhat they receive
Swedish Massage Therapy (SMT)ExperimentalPatients receive SMT over 45 minutes once weekly for 6 weeks.
Receives: Procedure: Swedish Massage Therapy (SMT)
Light Touch (LT)Sham comparatorPatients receive LT over 45 minutes once weekly for 6 weeks.
Receives: Procedure: Light Touch (LT) Control
Waitlist Control (WLC)Active comparatorPatients will sit and relax for 45 minutes before completing study assessments at weeks 3 and 6.
Receives: Other: Waitlist Control (WLC)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in cancer-related fatigue

    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.

    Measured: up to 6 weeks from the initiation of study intervention

Secondary outcomes (9)

  1. Change in plasma concentrations of pre-inflammatory cytokine IL-1beta

    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.

    Measured: up to 6 weeks from the initiation of study intervention

  2. Change in plasma concentrations of pre-inflammatory cytokine IL-1Ra

    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.

    Measured: up to 6 weeks from the initiation of study intervention

  3. Change in plasma concentrations of pre-inflammatory cytokine IL-6

    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.

    Measured: up to 6 weeks from the initiation of study intervention

  4. Change in plasma concentrations of pre-inflammatory cytokine sIL-6R

    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.

    Measured: up to 6 weeks from the initiation of study intervention

  5. Change in plasma concentrations of pre-inflammatory cytokine TNF-α

    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.

    Measured: up to 6 weeks from the initiation of study intervention

  6. Change in plasma concentrations of pre-inflammatory cytokine sTNFR2

    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.

    Measured: up to 6 weeks from the initiation of study intervention

  7. Change in plasma concentrations of pre-inflammatory cytokine IFN-γ

    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.

    Measured: up to 6 weeks from the initiation of study intervention

  8. Change in plasma concentrations of High-Sensitivity C-Reactive Protein (hsCRP)

    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.

    Measured: up to 6 weeks from the initiation of study intervention

  9. Change in plasma concentrations of anti-inflammatory cytokine IL-10

    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.

    Measured: up to 6 weeks from the initiation of study intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2021
  2. Study start17 Jun 2022
  3. Primary completion2 Aug 2025
  4. Study completion2 Aug 2025

Why it stopped: Lack of Funding

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Care provider, Investigator
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05067777
Sponsor's protocol ID
HCI144295
Other IDs
NCI-2021-09613, HCI144295, P30CA042014, R21CA263453
Acronym
mPROSTATE
Status last verified
Jul 2026
First submitted
17 Sep 2021
Last updated
13 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Curt GA, Breitbart W, Cella D, Groopman JE, Horning SJ, Itri LM, Johnson DH, Miaskowski C, Scherr SL, Portenoy RK, Vogelzang NJ. Impact of cancer-related fatigue on the lives of patients: new findings from the Fatigue Coalition. Oncologist. 2000;5(5):353-60. doi: 10.1634/theoncologist.5-5-353.

    PubMed 11040270

  • Hofman M, Ryan JL, Figueroa-Moseley CD, Jean-Pierre P, Morrow GR. Cancer-related fatigue: the scale of the problem. Oncologist. 2007;12 Suppl 1:4-10. doi: 10.1634/theoncologist.12-S1-4.

    PubMed 17573451

  • Lawrence DP, Kupelnick B, Miller K, Devine D, Lau J. Evidence report on the occurrence, assessment, and treatment of fatigue in cancer patients. J Natl Cancer Inst Monogr. 2004;(32):40-50. doi: 10.1093/jncimonographs/lgh027.

    PubMed 15263040

  • Mehnert A, Hartung TJ, Friedrich M, Vehling S, Brahler E, Harter M, Keller M, Schulz H, Wegscheider K, Weis J, Koch U, Faller H. One in two cancer patients is significantly distressed: Prevalence and indicators of distress. Psychooncology. 2018 Jan;27(1):75-82. doi: 10.1002/pon.4464. Epub 2017 Jun 16.

    PubMed 28568377

  • Ma Y, He B, Jiang M, Yang Y, Wang C, Huang C, Han L. Prevalence and risk factors of cancer-related fatigue: A systematic review and meta-analysis. Int J Nurs Stud. 2020 Nov;111:103707. doi: 10.1016/j.ijnurstu.2020.103707. Epub 2020 Jul 11.

    PubMed 32920423

  • National Coalition for Cancer Survivorship. Cancer survivorship survey: findings from an online survey of adult cancer patients. https://www.canceradvocacy.org/wpcontent/uploads/2019/09/NCCS-Survivorship-Survey-Final-Report.pdf. , 2019

  • Nail LM. My get up and go got up and went: fatigue in people with cancer. J Natl Cancer Inst Monogr. 2004;(32):72-5. doi: 10.1093/jncimonographs/lgh021.

    PubMed 15263043

  • Berger AM, Kuhn BR, Farr LA, Von Essen SG, Chamberlain J, Lynch JC, Agrawal S. One-year outcomes of a behavioral therapy intervention trial on sleep quality and cancer-related fatigue. J Clin Oncol. 2009 Dec 10;27(35):6033-40. doi: 10.1200/JCO.2008.20.8306. Epub 2009 Nov 2.

    PubMed 19884558

  • Bower JE. Prevalence and causes of fatigue after cancer treatment: the next generation of research. J Clin Oncol. 2005 Nov 20;23(33):8280-2. doi: 10.1200/JCO.2005.08.008. Epub 2005 Oct 11. No abstract available.

    PubMed 16219929

  • Berger AM, Mooney K, Alvarez-Perez A, Breitbart WS, Carpenter KM, Cella D, Cleeland C, Dotan E, Eisenberger MA, Escalante CP, Jacobsen PB, Jankowski C, LeBlanc T, Ligibel JA, Loggers ET, Mandrell B, Murphy BA, Palesh O, Pirl WF, Plaxe SC, Riba MB, Rugo HS, Salvador C, Wagner LI, Wagner-Johnston ND, Zachariah FJ, Bergman MA, Smith C; National comprehensive cancer network. Cancer-Related Fatigue, Version 2.2015. J Natl Compr Canc Netw. 2015 Aug;13(8):1012-39. doi: 10.6004/jnccn.2015.0122.

    PubMed 26285247

  • Boelhouwer IG, Vermeer W, van Vuuren T. The associations between late effects of cancer treatment, work ability and job resources: a systematic review. Int Arch Occup Environ Health. 2021 Feb;94(2):147-189. doi: 10.1007/s00420-020-01567-w. Epub 2020 Sep 15.

    PubMed 32929528

  • Bower JE, Ganz PA, Desmond KA, Rowland JH, Meyerowitz BE, Belin TR. Fatigue in breast cancer survivors: occurrence, correlates, and impact on quality of life. J Clin Oncol. 2000 Feb;18(4):743-53. doi: 10.1200/JCO.2000.18.4.743.

    PubMed 10673515

  • Curran SL, Beacham AO, Andrykowski MA. Ecological momentary assessment of fatigue following breast cancer treatment. J Behav Med. 2004 Oct;27(5):425-44. doi: 10.1023/b:jobm.0000047608.03692.0c.

    PubMed 15675633

  • Committee N-SMQoLS: Strategic Priorities. https://www.cancer.gov/aboutnci/organization/ccct/steering-committees/2015-sxqolsc-strategicpriorities Accessed 10-2020., 2015

  • Ebede CC, Jang Y, Escalante CP. Cancer-Related Fatigue in Cancer Survivorship. Med Clin North Am. 2017 Nov;101(6):1085-1097. doi: 10.1016/j.mcna.2017.06.007. Epub 2017 Aug 25.

    PubMed 28992856

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Swedish Massage Therapy (SMT) in people with Prostate Carcinoma, run by University of Utah at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Lack of Funding). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in cancer-related fatigue (time frame: up to 6 weeks from the initiation of study intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05067777, which also lists 91 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.

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