Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Emory University
With
National Center for Complementary and Integrative Health (NCCIH)
National Cancer Institute (NCI)
Age
18–65
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
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.
