Massage for Prostate Cancer-Related Fatigue (mPROSTATE)

NCT05067777 | Terminated Phase 2 DMC

• 4 other identifiers: HCI144295NCI-2021-09613P30CA042014R21CA263453
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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 psychology for cancer related fatigue.

Conditions

Prostate Carcinoma

Outcome Measures

Primary Outcomes (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.

  up to 6 weeks from the initiation of study intervention

Secondary Outcomes (9)

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

  up to 6 weeks from the initiation of study intervention

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

  up to 6 weeks from the initiation of study intervention

• Change in plasma concentrations of pre-inflammatory cytokine IL-6

  up to 6 weeks from the initiation of study intervention

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

  up to 6 weeks from the initiation of study intervention

• Change in plasma concentrations of pre-inflammatory cytokine TNF-α

  up to 6 weeks from the initiation of study intervention

Study Arms (3)

Swedish Massage Therapy (SMT)

EXPERIMENTAL

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

Procedure: Swedish Massage Therapy (SMT)

Light Touch (LT)

SHAM COMPARATOR

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

Procedure: Light Touch (LT) Control

Waitlist Control (WLC)

ACTIVE COMPARATOR

Patients will sit and relax for 45 minutes before completing study assessments at weeks 3 and 6.

Other: Waitlist Control (WLC)

Interventions

Swedish Massage Therapy (SMT) PROCEDURE

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.

Also known as: Massage, massage therapy

Swedish Massage Therapy (SMT)

Light Touch (LT) Control PROCEDURE

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.

Light Touch (LT)

Waitlist Control (WLC) OTHER

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

Also known as: Sham Intervention

Waitlist Control (WLC)

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Utah: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, 84112, United States

Location

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MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Massage

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Mark H Rapaport

  Huntsman Cancer Institute/ University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2021
• First Posted: October 5, 2021
• Study Start: June 17, 2022
• Primary Completion: August 2, 2025
• Study Completion: August 2, 2025
• Last Updated: December 15, 2025

Record last verified: 2025-12

Locations

US (1)