Efficacy of Massage for the Treatment of Cancer-Related Fatigue (CRF) in Prostate Cancer Survivors

Completed · Not applicable

Conditions studied: Cancer-related Problem/Condition

In brief

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.

Key facts

Study ID: NCT03187275
Run by: Emory University
People needed: 8
Starts: 2018-01-22
Expected to finish: 2019-03-31
Last updated by the study team: 2019-06-06

Who can join

Age: 45 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Executive Park 12 — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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