Prostate Carcinoma
Conditions
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
With over 15.5 million cancer survivors today in the United States, increased attention is being given to quality of life (QOL) after cancer treatment. Cancer-related fatigue (CRF), a persistent, subjective sense of physical, emotional, and/or cognitive exhaustion related to cancer or its treatment that is not proportional to recent activity (National Comprehensive Cancer Network, accessed Oct2020), is the most common and one of the most devastating symptoms among patients with cancer. CRF occurs across the spectrum of cancer types and treatments and has a negative impact on all areas of function, including mood, physical function, work performance, social interaction, family care, cognitive performance, schoolwork, and community activities. CRF can persist for months or years after cancer therapy is completed. CRF has been designated a high-priority research area by the National Cancer Institute (NCI) and is 1 of the 5 highest-priority research areas designated by the NCI Clinical Oncology Research. This study is a phase II, 3-arm, randomized comparison of single-blinded once-weekly Swedish Massage Therapy (SMT) vs. Light Touch (LT) Control vs. unblinded waitlist control (WLC) for 6 weeks. We chose once-a-week sessions for 6 weeks to match the length of our completed National Center for Complementary and Integrative Health (NCCIH) trial of SMT vs. LT for breast cancer survivors with CRF. Subjects who complete SMT or LT will be interviewed in person, by telemedicine, or by telephone at 6 and 12 weeks after the last study visit in order to evaluate the sustained effects of SMT and LT. We hypothesize that SMT will have a clinically meaningful benefit in improving fatigue, mood, and quality of life (QOL) in Prostate Cancer (PCa) patients, and that this will correlate with favorable changes in physiological parameters that may underlie CRF. Demographic, medical, clinical, and biological characteristics will be compared between groups of subjects randomized to SMT, LT, or WLC. Any treatment group differences in PCa grade and time since completion of radiation therapy, or baseline Brief Fatigue Inventory (BFI) fatigue score, may affect treatment-related change in fatigue or biological measures related to inflammation, or the post-treatment duration of benefit. While groups are expected to be similar on these characteristics, any variable with a p ≤ 0.10 difference between groups will be considered as a candidate covariate or stratification variable for statistical tests of the study hypotheses.
Interventions
PROCEDURESwedish Massage Therapy (SMT)
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.
PROCEDURELight Touch (LT) Control
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.
Subjects randomized to WLC will sit and relax for 45 minutes.
Sponsors
National Cancer Institute (NCI)
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Age
45 Years to No maximum
Healthy volunteers
No
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 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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in cancer-related fatigue | up to 6 weeks from the initiation of study intervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in plasma concentrations of pre-inflammatory cytokine IL-1Ra | up to 6 weeks from the initiation of study intervention | To evaluate whether the hypothesized decrease in cancer-related fatigue with SMT is associated with modulation of specific immune system factors underlying chronic inflammation. This outcome measure will report the mean change in plasma concentrations of pre-inflammatory cytokine IL-1Ra from baseline to 6 weeks after initiation of the study intervention. Further statistical analysis will assess the association between the change in cytokine IL-1Ra and MFI scores. |
| Change in plasma concentrations of pre-inflammatory cytokine IL-6 | up to 6 weeks from the initiation of study intervention | To evaluate whether the hypothesized decrease in cancer-related fatigue with SMT is associated with modulation of specific immune system factors underlying chronic inflammation. This outcome measure will report the mean change in plasma concentrations of pre-inflammatory cytokine IL-6 from baseline to 6 weeks after initiation of the study intervention. Further statistical analysis will assess the association between the change in cytokine IL-6 and MFI scores. |
| Change in plasma concentrations of pre-inflammatory cytokine sIL-6R | up to 6 weeks from the initiation of study intervention | To evaluate whether the hypothesized decrease in cancer-related fatigue with SMT is associated with modulation of specific immune system factors underlying chronic inflammation. This outcome measure will report the mean change in plasma concentrations of pre-inflammatory cytokine sIL-6R from baseline to 6 weeks after initiation of the study intervention. Further statistical analysis will assess the association between the change in cytokine sIL-6R and MFI scores. |
| Change in plasma concentrations of pre-inflammatory cytokine TNF-α | up to 6 weeks from the initiation of study intervention | To evaluate whether the hypothesized decrease in cancer-related fatigue with SMT is associated with modulation of specific immune system factors underlying chronic inflammation. This outcome measure will report the mean change in plasma concentrations of pre-inflammatory cytokine TNF-α from baseline to 6 weeks after initiation of the study intervention. Further statistical analysis will assess the association between the change in cytokine TNF-α and MFI scores. |
| Change in plasma concentrations of pre-inflammatory cytokine IL-1beta | up to 6 weeks from the initiation of study intervention | To evaluate whether the hypothesized decrease in cancer-related fatigue with SMT is associated with modulation of specific immune system factors underlying chronic inflammation. This outcome measure will report the mean change in plasma concentrations of pre-inflammatory cytokine IL-1beta from baseline to 6 weeks after initiation of the study intervention. Further statistical analysis will assess the association between the change in IL-1beta and MFI scores. |
| Change in plasma concentrations of pre-inflammatory cytokine IFN-γ | up to 6 weeks from the initiation of study intervention | To evaluate whether the hypothesized decrease in cancer-related fatigue with SMT is associated with modulation of specific immune system factors underlying chronic inflammation. This outcome measure will report the mean change in plasma concentrations of pre-inflammatory cytokine IFN-γ from baseline to 6 weeks after initiation of the study intervention. Further statistical analysis will assess the association between the change in cytokine IFN-γ and MFI scores. |
| Change in plasma concentrations of High-Sensitivity C-Reactive Protein (hsCRP) | up to 6 weeks from the initiation of study intervention | To evaluate whether the hypothesized decrease in cancer-related fatigue with SMT is associated with modulation of specific immune system factors underlying chronic inflammation. This outcome measure will report the mean change in plasma concentrations of hsCRP from baseline to 6 weeks after initiation of the study intervention. Further statistical analysis will assess the association between the change in hsCRP and MFI scores. |
| Change in plasma concentrations of anti-inflammatory cytokine IL-10 | up to 6 weeks from the initiation of study intervention | To evaluate whether the hypothesized decrease in cancer-related fatigue with SMT is associated with modulation of specific immune system factors underlying chronic inflammation. This outcome measure will report the mean change in plasma concentrations of anti-inflammatory cytokine IL-10 from baseline to 6 weeks after initiation of the study intervention. Further statistical analysis will assess the association between the change in anti-inflammatory cytokine IL-10 and MFI scores. |
| Change in plasma concentrations of pre-inflammatory cytokine sTNFR2 | up to 6 weeks from the initiation of study intervention | To evaluate whether the hypothesized decrease in cancer-related fatigue with SMT is associated with modulation of specific immune system factors underlying chronic inflammation. This outcome measure will report the mean change in plasma concentrations of pre-inflammatory cytokine sTNFR2 from baseline to 6 weeks after initiation of the study intervention. Further statistical analysis will assess the association between the change in cytokine sTNFR2 and MFI scores. |
Countries
United States
Outcome results
None listed