Efficacy of Massage for the Treatment of Cancer-Related Fatigue (CRF) in Prostate Cancer Survivors
| Status: | Recruiting |
|---|---|
| Conditions: | Prostate Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 45 - Any |
| Updated: | 8/31/2018 |
| Start Date: | January 22, 2018 |
| End Date: | February 28, 2019 |
| Contact: | Tanja Mletzko, MD |
| Email: | tmletzk@emory.edu |
| Phone: | 404-712-5063 |
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.
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.
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.
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.
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
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