Clinical trial · Interventional
Massage for Prostate Cancer-Related Fatigue (mPROSTATE)
NCT05067777CI-TRIAL-00117803mPROSTATEterminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of Funding
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Carcinoma | Prostate Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Light Touch (LT) Control | Procedure | — | UNRESOLVED |
| Swedish Massage Therapy (SMT) | Procedure | — | UNRESOLVED |
| Waitlist Control (WLC) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Swedish Massage Therapy (SMT)
- description
- Patients receive SMT over 45 minutes once weekly for 6 weeks.
- interventionNames
- Procedure: Swedish Massage Therapy (SMT)
- type
- SHAM_COMPARATOR
- label
- Light Touch (LT)
- description
- Patients receive LT over 45 minutes once weekly for 6 weeks.
- interventionNames
- Procedure: Light Touch (LT) Control
- type
- ACTIVE_COMPARATOR
- label
- Waitlist Control (WLC)
- description
- Patients will sit and relax for 45 minutes before completing study assessments at weeks 3 and 6.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 45 Years
Show eligibility criteria text
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 studyReferences
Publications (91)
- BACKGROUNDCurt 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. PMID 11040270
- BACKGROUNDHofman 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. PMID 17573451
- BACKGROUNDLawrence 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. PMID 15263040
- BACKGROUNDMehnert 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. PMID 28568377
- BACKGROUNDMa 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. PMID 32920423
- BACKGROUNDNational 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
- BACKGROUNDNail 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. PMID 15263043