Clinical trial NCT05067777: Massage for Prostate Cancer-Related Fatigue, mPROSTATE Study
Official title: Massage for Prostate Cancer-Related Fatigue
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Prostate Carcinoma
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-10-05
Enrollment: 57
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: PRIMARY OBJECTIVE:

I. To conduct a preliminary study to evaluate whether a 6-week Swedish Massage Therapy (SMT) intervention decreases cancer-related fatigue (CRF) significantly more than Light Touch (LT) or Wait List Control (WLC) among prostate cancer (PCa) survivors who have received both radiation and androgen deprivation therapy.

SECONDARY OBJECTIVE:

I. To evaluate whether the hypothesized decrease in cancer-related fatigue with SMT is associated with modulation of specific immune system factors underlying chronic inflammation.

EXPLORATORY OBJECTIVES:

I. To evaluate whether SMT improves self-reported fatigue, quality of life, depression, and anxiety significantly more than LT or WLC.

II. To gather preliminary data about the sustained actions of 6 weeks of SMT versus LT on CRF, at 6 and 12 weeks after the intervention.

OUTLINE: Patients are randomized to 1 of 3 arms.

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

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

Arm III: Patients receive no intervention for 6 weeks.

After completion of study, patients are followed up at 12 and 18 weeks.

Eligibility criteria: 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 undergoing androgen depravation therapy with serum testosterone levels \< 20 ng/ml
* 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 supine for one hour at a time, 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

Primary outcomes:
measure: Change in cancer-related fatigue
timeFrame: Baseline to 6 weeks
Secondary outcomes:
measure: 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
timeFrame: Baseline up to 6 weeks
measure: Correlation between change in plasma concentrations of pre-inflammatory cytokines with cancer-related fatigue
timeFrame: Up to 6 weeks
measure: Correlation between change in plasma concentrations of high sensitivity (hs)-CRP with cancer-related fatigue
timeFrame: up to 6 weeks
measure: Correlation between change in plasma concentrations of anti-inflammatory cytokines with cancer-related fatigue
timeFrame: up to 6 weeks
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute/University of Utah
state: Utah
Study officials:
affiliation: Huntsman Cancer Institute/ University of Utah
name: Mark H Rapaport
role: PRINCIPAL_INVESTIGATOR
References: