Efficacy of Swedish Massage Therapy on Cancer-related Fatigue in Cancer Survivors

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Emory University
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Mark H. Rapaport, Emory University
ClinicalTrials.gov Identifier:
NCT01926678
First received: August 19, 2013
Last updated: May 15, 2014
Last verified: May 2014
  Purpose

With approximately 12 million cancer survivors today in the United States alone, increased attention is being given to quality of life after cancer treatment. Cancer-related fatigue (CRF) is one of the most prevalent and debilitating symptoms experienced by people with cancer. It can persist for months or years after cancer therapy is completed and has a negative impact on all areas of function. Meaningful evidence-based treatment options for CRF are extremely limited and finding safe, inexpensive, and effective interventions for managing this distressing symptom are urgently needed. Basic research has shown that activation of the immune system can cause potent changes in behavior including reduced activity, fatigue, and decreased social behavior. Furthermore, research over the last decade has found a relationship between levels of CRF with increased inflammation. Thus, study of therapies that may decrease immune system activation in the setting of CRF represents a possible target for intervention. Massage therapy is one of the fastest growing alternative therapies and has a high rate of acceptance for symptom management among cancer patients. Massage has been shown in smaller studies with cancer patients to modulate the immune system. Moreover, massage has been demonstrated to significantly decrease markers of immune system activation in normal subjects. There are no published randomized controlled trials examining either the role of massage as an intervention primarily for CRF or investigating whether massage related decreases in immune system activation are responsible for improvement in CRF. This proposal investigates the effects of massage therapy on CRF among breast cancer survivors. The investigators' primary hypothesis is that Swedish Massage Therapy (SMT) will decrease CRF compared to a light touch condition and wait list control. The investigators' secondary hypothesis is that SMT will decrease CRF by reducing immune system activation. The investigators' main exploratory hypothesis is that a decrease in CRF will increase quality of life among cancer survivors.


Condition Intervention Phase
Cancer Related Fatigue
Other: Swedish massage therapy
Other: Light touch therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Swedish Massage Therapy on Cancer-related Fatigue in Cancer

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Cancer-Related Fatigue [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    The primary aim of this study is to determine whether a 6-week Swedish massage therapy (SMT) intervention can decrease cancer-related fatigue, as measured by the Multidimensional Fatigue Inventory (MFI), among breast cancer survivors who have received both radiation and chemotherapy and have CRF. We hypothesize that SMT will decrease fatigue more than light touch (LT) or a wait list control (WLC) condition as assessed by the MFI.


Secondary Outcome Measures:
  • Inflammation [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    A secondary aim of this study is to determine whether the hypothesized decrease in cancer-related fatigue is due to Swedish massage therapy modulating the immune system of subjects with cancer-related fatigue to decrease chronic inflammation.


Estimated Enrollment: 72
Study Start Date: November 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Swedish massage therapy
Swedish massage therapy once per week for 6 weeks
Other: Swedish massage therapy
Active Comparator: Light touch therapy
Light touch therapy once per week for 6 weeks
Other: Light touch therapy
Wait list
A 6 week wait list, followed by randomization to massage therapy or light touch therapy once per week for 6 weeks
Other: Swedish massage therapy Other: Light touch therapy

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women
  • ages 18 to 65 (women above the age of 65 may be included at PI discretion)
  • with Stage 0-IIIA breast cancer, status-post surgery treated with standard anthracycline- and/or taxane-based chemotherapy plus radiation (6 weeks of definitive whole breast or chestwall irradiation at a dose of 50.0 Gy with a 10-16 Gy boost).
  • Patients will be between 6 months and 1-year post radiation treatment. Based on ICD-10 proposed criteria, a diagnosis of CRF will require 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 comorbid psychiatric disorders (schizophrenia, depression, generalized anxiety disorder, bipolar disorder, dementia, delirium or OCD).
  • Brief Fatigue Inventory (BFI) score of >25.
  • Satisfactory results of screening safety labs, urine pregnancy test and drug test.
  • Ability to understand study procedures and to comply with them for the entire length of the study.
  • Women of reproductive capability will be enrolled, but each woman needs to discuss with the study team the method of birth control used and if the method is a reliable and effective method for her. If a woman becomes pregnant during the course of active study participation, she must agree prior to enrolling in the study that she will report the pregnancy to the study team. With a confirmed pregnancy, the subject will no longer receive the assigned treatment, but will continue to be followed per protocol.

Exclusion Criteria:

  • Inability to lay supine for one hour at a time, given the nature of the massage intervention.
  • Subjects who are 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 MCU/mL), uncontrolled pain, medical problems associated with fatigue: chronic obstructive pulmonary disease, congestive heart failure, renal disease, hepatic dysfunction, autoimmune disease, neurological disorders such as multiple sclerosis or Parkinson's disease, and sleep apnea.
  • Medications felt to be clinically contributing to fatigue based on the investigator's history, physical examination, and assessment including: opioids, sedating anti-histamines, antidepressants, anxiolytics or neuroleptics.
  • Body-mass index less than 18.5 (kg/m2).
  • Treatment with corticosteroids or other immunosuppressants within the past 6 months.
  • Unable to comply with the protocol for any reason.
  • Use of anti-inflammatory medications such as corticosteroids or other drugs known to affect the immune system will also be exclusionary as will the use of psychotropic medications including antidepressants and anti-anxiety agents.
  • Use of non-steroidal anti-inflammatory drugs and aspirin is allowed but must be tracked.
  • Other exclusion criteria include: illicit drug use, shift work, current 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.
  • Subjects who have used massage as a therapeutic modality (medical or psychological) at any point in their lives for the treatment of medical conditions.
  • Subjects who have massages on a regular basis. Regular massage usage will be operationally defined as receiving 4 or more massages/year for the last 5 years.
  • Subjects currently employing any other CAM manual therapy and/or holistic therapies to treat a perceived health problem. However, since past experience with CAM therapies should not confound any of the analyses of the experiments proposed in this study, we will not exclude individuals who have engaged in a CAM manual therapy in the past, nor will we exclude individuals who practice yoga or meditation for well-being, take vitamins or use nicotine.
  • Adults over the age of 65 will generally be excluded from the study. This population tends to undergo changes in the physiological parameters we are evaluating. Therefore, inclusion of this population would skew various biological measures and this pilot investigation does not have a large enough sample size to control for such variability it. Older subjects could be included at the discretion of the PI.
  • People unable to read and understand the informed consent document because of language difficulties.
  • Women who are pregnant or lactating.
  • Women who become pregnant while enrolled will be discontinued from the study and will be instructed to exercise, which is the standard recommendation for cancer-related fatigue. Inability or unwillingness of individual to give written informed consent.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01926678

Contacts
Contact: Sherry Edwards 404-778-2497 saedwar@emory.edu

Locations
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Sherry Edwards    404-778-2497    saedwar@emory.edu   
Sub-Investigator: Boadie Dunlop, MD         
Sub-Investigator: Mylin Torres, MD         
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Mark H Rapaport, MD Emory University
  More Information

No publications provided

Responsible Party: Mark H. Rapaport, Professor and Chairman, Emory University
ClinicalTrials.gov Identifier: NCT01926678     History of Changes
Other Study ID Numbers: IRB00062853, R21AT007090
Study First Received: August 19, 2013
Last Updated: May 15, 2014
Health Authority: United States: Institutional Review Board
United States: Data and Safety Monitoring Board

Keywords provided by Emory University:
swedish massage
fatigue
light touch
inflammation

Additional relevant MeSH terms:
Fatigue
Signs and Symptoms

ClinicalTrials.gov processed this record on July 29, 2014