Clinical trial NCT03187275: Efficacy of Massage for the Treatment of Cancer-Related Fatigue (CRF) in Prostate Cancer Survivors
Official title: Efficacy of Massage for the Treatment of Cancer-Related Fatigue (CRF) in Prostate Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer-related Problem/Condition
Keywords: Cancer Related Fatigue (CRF)
Prostate Cancer
Swedish Massage Therapy (SMT)
Cancer
Quality of Life (QOL)
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2017-06-14
Enrollment: 8
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Cancer-related fatigue (CRF) is a prevalent and debilitating symptom experienced by cancer survivors. CRF can persist for months or years after cancer therapy is completed and has a negative impact on all areas of mental and physical function. Treatment options for CRF are extremely limited and finding safe, inexpensive, and effective interventions for managing this distressing symptom are urgently needed. Massage therapy is one of the fastest growing complementary therapies. A recently completed study in breast cancer survivors with CRF found that Swedish Massage Therapy (SMT) caused a significant reduction in fatigue and improvement in quality of life. This study investigates the effects of massage therapy on CRF among prostate cancer survivors. The study will evaluate whether SMT improves quality of life, depression, and anxiety. Second, this study will evaluate if SMT reduces CRF by decreasing the pro-inflammatory cytokine Interleukin-6 (IL-6). Lastly, to establish measures of reduced fatigue beyond self report at the treatment visits, the researchers will implement continuous, real-time monitoring of physiologic and psychological signs and symptoms, throughout the treatment period. This study will improve care for CRF and other hard-to-manage symptoms of cancer treatment and provide preliminary evidence of immune modulation as a potential mechanism of action.

This study is a randomized clinical trial to test the efficacy of Swedish massage therapy (SMT) versus an active control condition (light touch, LT) on cancer related fatigue in men with prostatic cancer, at least 2 months after the end of their radiation therapy. The primary outcome is the Multidimensional Fatigue Inventory (MFI). Secondary outcomes are the Patient-Reported Outcomes Measurement System (PROMIS) Fatigue Scale, plasma concentrations of cytokine IL-6, self-reported quality of life, depression, and anxiety, wearable measures of activity and sleep, and Automated Monitoring of Symptom Severity (AMoSS) ratings.

Detailed description: Fatigue is the most common, and one of the most devastating symptoms among patients with cancer. According to the National Comprehensive Cancer Network (NCCN), cancer-related fatigue (CRF) is "a distressing, persistent, subjective sense of physical, emotional, and/or cognitive exhaustion related to cancer or its treatment that is not proportional to recent activity". Fatigue occurs across the spectrum of cancer types and treatments. CRF 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 has been rated as more troublesome and to have a greater negative impact on quality of life than other cancer-related symptoms such as pain, depression, and nausea. CRF can persist for months or years after cancer therapy is completed.

Meaningful, evidence-based treatment options for CRF are limited. Over 50% of patients with cancer have used a complementary and alternative medicine (CAM) approach for symptom management and quality of life. One of the widely employed CAM interventions is massage therapy. Most of the studies investigating massage for patients with cancer focus on depression, anxiety, or pain as the outcomes of interest. A previous investigation of breast cancer survivors reported decreases in mood symptoms and an improvement in fatigue, however, CRF was not the primary outcome measure. This randomized clinical trial will test the efficacy of Swedish massage therapy (SMT) vs. an active control condition (light touch, LT) on cancer related fatigue in men with prostatic cancer, at least 2 months after the end of their radiation therapy. Participants will receive weekly treatments for 6 weeks.

The aims of the study are as follows:

Aim 1: To conduct a feasibility study to determine whether a 6-week SMT intervention can decrease CRF among prostate cancer survivors who have received radiation therapy and have CRF.

Aim 2: To determine whether the hypothesized decrease in CRF is due to SMT modulating the immune system of subjects with CRF. The researchers hypothesize that SMT will decrease plasma concentrations of IL-6 (a pro-inflammatory cytokine) more than LT and that the decrease in plasma IL-6 will mediate the decrease in fatigue as assessed with the MFI.

Aim 3: To determine whether SMT improves self-reported quality of life, depression, and anxiety more than LT, as assessed (respectively) by the Quality of Life, Enjoyment, and Satisfaction Questionnaire - short form (Q-LES-Q), the Quick Inventory of Depressive Symptoms - Self-Report (QIDS-SR), and the Generalized Anxiety Disorder 7-item (GAD-7) scale.

Aim 4: To evaluate the peripheral physiological changes associated with treatment of CRF. The researchers predict that treatment with SMT will cause a progressive increase in wearable measures of activity and step count, improved sleep quality (duration and latency), and decrease in pulse over 6 weeks when compared to baseline measures.

Aim 5: To determine if valid and useful tests of SMT effectiveness for treating CRF can be obtained through daily self-report ratings of fatigue and continuous monitoring of physiological signs. The researchers predict that SMT will cause a significant decrease in daily self-ratings of fatigue and mood when compared to baseline ratings and that the decreases in daily self-ratings of fatigue and mood observed with SMT will correlate with changes in Q-LES-Q, QIDS-SR, GAD-7 scores obtained at in-person visits as well as physiological signs.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of prostate cancer
* At least 2 months after the end of radiation therapy
* Brief Fatigue Inventory (BFI) score of \>25
* Satisfactory results of screening safety labs, serum testosterone test and drug test
* Ability to understand study procedures and to comply with them for the entire length of the study

Exclusion Criteria:

* Inability to lay supine for one hour at a time, given the nature of the massage intervention
* Actively suicidal or homicidal
* Medical conditions felt to be clinically contributing to fatigue based on the investigator's history, physical examination, and assessment: anemia (hemoglobin less than 10 g/dl), hypothyroidism (thyroid stimulating hormone greater than 4.6 microUnits per milliliter (mcU/mL)), uncontrolled pain, or medical problems associated with fatigue, including: chronic obstructive pulmonary disease, congestive heart failure, renal disease, hepatic dysfunction, autoimmune disease, neurological disorders such as multiple sclerosis or Parkinson's disease, and poorly controlled sleep apnea
* Medications felt to be clinically contributing to fatigue based on the investigator's history, physical examination, and assessment. Those may include: antidepressants, chronic use of long-acting anxiolytics or neuroleptics
* Treatment with high dose systemic corticosteroids or continuous use of other immunosuppressants within the past 30 days
* Unable to comply with the protocol for any reason
* Use of non-steroidal anti-inflammatory drugs; aspirin use is allowed but must be tracked
* Illicit drug use
* Shift work
* Currently dieting
* Excessive, regular use of alcohol (more than two 5 ounce glasses of wine or equivalents/day) or a history of binge drinking (more than 7 drinks/24 hour period) within the last 6 months
* Have used massage as a therapeutic modality (medical or psychological) at any point for the treatment of medical conditions
* Have massages on a regular basis, defined as receiving 4 or more massages per year for the last 5 years
* Currently employing any other complementary and alternative medicine (CAM) manual therapy and/or holistic therapies to treat a perceived health problem
* Unable to read and understand the informed consent document because of language difficulties
* Inability or unwillingness to give written informed consent

Primary outcomes:
measure: Change in Multidimensional Fatigue Inventory (MFI) score
timeFrame: Baseline, Week 6
Secondary outcomes:
measure: Change in Patient-Reported Outcome Measurement System (PROMIS) Fatigue Scale score
timeFrame: Baseline, Week 6
measure: Change in plasma IL-6
timeFrame: Baseline, Week 6
measure: Change in Quality of Life, Enjoyment, and Satisfaction Questionnaire - short form (Q-LES-Q) score
timeFrame: Baseline, Week 6
measure: Change in Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR) score
timeFrame: Baseline, Week 6
measure: Change in Generalized Anxiety Disorder 7-item (GAD-7) Scale score
timeFrame: Baseline, Week 6
measure: Change in circadian variation of activity
timeFrame: Baseline, Week 6
measure: Change in step count
timeFrame: Baseline, Week 6
measure: Change in sleep duration
timeFrame: Baseline, Week 6
measure: Change in sleep latency
timeFrame: Baseline, Week 6
measure: Change in Automated Monitoring of Symptom Severity (AMoSS) survey score
timeFrame: Baseline, Week 6
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Executive Park 12
state: Georgia
Study officials:
affiliation: Emory University
name: Mark Rapaport, MD
role: PRINCIPAL_INVESTIGATOR
References: