Massage for Prostate Cancer-Related Fatigue, mPROSTATE Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Massage for Prostate Cancer-Related Fatigue

Conditions
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Prostate Carcinoma

Intervention / Treatment
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* Procedure: Massage Therapy
* Other: Questionnaire Administration
* Procedure: Sham Intervention


Participation Criteria
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Eligibility Criteria
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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) 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

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (SMT)<br>Patients receive SMT over 45 minutes once weekly for 6 weeks. | Procedure: Massage Therapy<br>* Receive SMT<br>* Other names: Massage;Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Sham Comparator: Arm II (LT)<br>Patients receive LT over 45 minutes once weekly for 6 weeks. | Other: Questionnaire Administration<br>* Ancillary studies<br>Procedure: Sham Intervention<br>* Receive light touch control procedure<br>* Other names: Sham Comparator;|
| Active Comparator: Arm III (waitlist)<br>Patients receive no intervention for 6 weeks. | Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cancer-related fatigue | Will be assessed by Multidimensional Fatigue Inventory (MFI)-20. | Baseline to 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | evaluate whether the hypothesized decrease in cancer-related fatigue with SMT is associated with modulation of specific immune system factors underlying chronic inflammation | Baseline up to 6 weeks | 
| Correlation between change in plasma concentrations of pre-inflammatory cytokines with cancer-related fatigue | evaluate whether the hypothesized decrease in cancer-related fatigue with SMT is associated with modulation of specific immune system factors underlying chronic inflammation | Up to 6 weeks | 
| Correlation between change in plasma concentrations of high sensitivity (hs)-CRP with cancer-related fatigue | evaluate whether the hypothesized decrease in cancer-related fatigue with SMT is associated with modulation of specific immune system factors underlying chronic inflammation | up to 6 weeks | 
| Correlation between change in plasma concentrations of anti-inflammatory cytokines with cancer-related fatigue | evaluate whether the hypothesized decrease in cancer-related fatigue with SMT is associated with modulation of specific immune system factors underlying chronic inflammation | up to 6 weeks |