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

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.