TERMINATED

Massage for Prostate Cancer-Related Fatigue (mPROSTATE)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Massage for Prostate Cancer-Related Fatigue (mPROSTATE)

Quick Facts

Study Start:2022-06-17

Study Completion:2025-08-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:TERMINATED

Study ID

NCT05067777

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.

Ages Eligible for Study:45 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Principal Investigator

Mark H Rapaport

PRINCIPAL_INVESTIGATOR

Huntsman Cancer Institute/ University of Utah

Study Locations (Sites)

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, 84112

United States

Collaborators and Investigators

Sponsor: University of Utah

Mark H Rapaport, PRINCIPAL_INVESTIGATOR, Huntsman Cancer Institute/ University of Utah

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 Registration Dates

Study Start Date2022-06-17

Study Completion Date2025-08-02

Study Record Updates

Study Start Date2022-06-17

Study Completion Date2025-08-02

Terms related to this study

Additional Relevant MeSH Terms

Prostate Carcinoma