Efficacy of Swedish Massage Therapy on Cancer-related Fatigue in Cancer Survivors
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01926678 |
Recruitment Status
:
Completed
First Posted
: August 21, 2013
Last Update Posted
: July 11, 2016
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cancer Related Fatigue | Other: Swedish massage therapy Other: Light touch therapy | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 66 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Efficacy of Swedish Massage Therapy on Cancer-related Fatigue in Cancer |
Study Start Date : | November 2013 |
Actual Primary Completion Date : | May 2016 |
Actual Study Completion Date : | May 2016 |
Arm | Intervention/treatment |
---|---|
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 |
- Cancer-Related Fatigue [ Time Frame: 6 weeks ]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.
- Inflammation [ Time Frame: 6 weeks ]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.

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Women
- ages 18 to 65 (women above the age of 65 may be included at PI discretion)
- • with Stage 0-III breast cancer, status-post surgery treated with standard chemotherapy/chemoprevention and/or radiation.
- • Patients will be between 3 months and 4-years post treatment. Ongoing chemoprevention therapy is permissible. 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 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 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01926678
United States, Georgia | |
Emory University | |
Atlanta, Georgia, United States, 30322 |
Principal Investigator: | Mark H Rapaport, MD | Emory University |
Responsible Party: | Mark H. Rapaport, Professor and Chairman, Emory University |
ClinicalTrials.gov Identifier: | NCT01926678 History of Changes |
Other Study ID Numbers: |
IRB00062853 R21AT007090 ( U.S. NIH Grant/Contract ) |
First Posted: | August 21, 2013 Key Record Dates |
Last Update Posted: | July 11, 2016 |
Last Verified: | July 2016 |
Keywords provided by Mark H. Rapaport, Emory University:
swedish massage fatigue light touch inflammation |
Additional relevant MeSH terms:
Fatigue Signs and Symptoms |