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

Phase 2

Recruiting

Led By Mark H Rapaport

Research Sponsored by University of Utah

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of Cancer-Related Fatigue (CRF) based on ICD-10 criteria with evidence from history, physical exam, and laboratory findings

Male subjects aged 45 years old or older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 weeks

Awards & highlights

mPROSTATE Trial Summary

This trial is testing whether massage can help reduce cancer-related fatigue. Massage has well known health benefits, and this trial will find out if it can help reduce fatigue caused by cancer.

Who is the study for?

Men over 45 with prostate cancer who've finished radiation therapy at least 2 months ago but no more than 6 years, currently on androgen deprivation therapy, experiencing significant fatigue not caused by other conditions like anemia or hypothyroidism. They must be able to lay down for an hour and not have used massage for fatigue before.Check my eligibility

What is being tested?

The mPROSTATE study is testing if massage can reduce cancer-related fatigue in men with prostate cancer better than traditional treatments. Participants will receive either real massage therapy or a sham intervention while their responses are monitored through questionnaires.See study design

What are the potential side effects?

While the trial primarily involves massage, which typically has minimal side effects such as temporary soreness or discomfort, the specific side effects related to this trial's interventions aren't detailed in the provided information.

mPROSTATE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with fatigue related to my cancer.

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I am a man aged 45 or older.

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I often feel very tired.

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I am on hormone therapy for cancer, and my testosterone is below 20 ng/ml.

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My prostate cancer diagnosis was confirmed through tissue examination.

mPROSTATE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in cancer-related fatigue

Secondary outcome measures

Change in plasma concentrations of pre-inflammatory cytokines (IL-1beta, IL 1Ra, IL-6, sIL-6R, TNF-alpha, sTNFR2, IFN-gamma), high sensitivity (hs)CRP, and the anti-inflammatory cytokine IL-10

Correlation between change in plasma concentrations of anti-inflammatory cytokines with cancer-related fatigue

Correlation between change in plasma concentrations of high sensitivity (hs)-CRP with cancer-related fatigue

+1 more

mPROSTATE Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Arm I (SMT)Experimental Treatment2 Interventions

Patients receive SMT over 45 minutes once weekly for 6 weeks.

Group II: Arm III (waitlist)Active Control1 Intervention

Patients receive no intervention for 6 weeks.

Group III: Arm II (LT)Placebo Group2 Interventions

Patients receive LT over 45 minutes once weekly for 6 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Massage Therapy

2012

Completed Phase 2

~840

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor

1,099 Previous Clinical Trials

1,778,632 Total Patients Enrolled

7 Trials studying Prostate Cancer

5,292 Patients Enrolled for Prostate Cancer

National Cancer Institute (NCI)NIH

13,665 Previous Clinical Trials

40,925,797 Total Patients Enrolled

560 Trials studying Prostate Cancer

507,038 Patients Enrolled for Prostate Cancer

Mark H RapaportPrincipal InvestigatorHuntsman Cancer Institute/ University of Utah

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is massage therapy beneficial and risk-free for patients?

"After assessing the safety of Massage Therapy, our team at Power awarded it a score of 2 due to existing evidence confirming its security without any studies demonstrating its efficacy."

Answered by AI

What is the current sample size of participants in this research program?

"Affirmative. Clinicaltrials.gov presents evidence that this research project is actively in search of participants since its posting on April 25th 2022 and latest amendment on May 16th 2022. The team is currently seeking 57 individuals to enrol at a single location."

Answered by AI

Are there any opportunities for participants to join this experiment?

"Affirmative. The information on clinicaltrials.gov reveals that this scientific endeavour, which was first made available to the public on April 25th 2022 is still looking for participants. 57 volunteers need to be sourced from just one site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Massage for Prostate Cancer-Related Fatigue, mPROSTATE Study

2022. "Massage for Prostate Cancer-Related Fatigue, mPROSTATE Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05067777.