Clinical trial NCT01071109: The Clinical and Biochemical Effect of Therapeutic Massage on Fatigue and Insomnia in Women With Breast Cancer Receiving Radiation Therapy
Official title: The Clinical and Biochemical Effect of Therapeutic Massage on Fatigue and Insomnia in Women With Breast Cancer Receiving Radiation Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Fatigue
Insomnia
Keywords: Therapeutic massage
massage
inflammation
fatigue
insomnia
radiation therapy
breast cancer
Breast Cancer patients receiving radiation therapy
Lead sponsor: Floyd Memorial Hospital and Health Services
Sponsor class: OTHER
Collaborators: name: Indiana University
First posted: 2010-02-19
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: A majority of women with breast cancer receive radiation therapy, and many of them experience the debilitating side effects of fatigue and insomnia. There is a need for an effective treatment that could ameliorate these symptoms and improve quality of life in the radiation therapy population.

The primary purpose of the proposed research is to study the impact of massage therapy as a tool for the management of fatigue and insomnia experienced by women diagnosed with breast cancer and receiving radiation therapy.

The secondary purpose is to explain, at the biochemical level, the effect of therapeutic massage on the level of fatigue and insomnia in radiation therapy patients. Prior studies have shown an association between fatigue and insomnia in the breast cancer patient following radiation therapy and the presence of inflammation as evidenced by increased proinflammatory cytokine production. The investigators hypothesize that therapeutic massage will ameliorate the symptoms of fatigue and insomnia associated with radiation therapy, and will be associated with a reduction in the plasma levels of interleukin-6 (IL-6),soluble IL-6 receptor (sIL-6R/CD126), and C-Reactive Protein (CRP). This reduction in proinflammatory biomarkers will be due to the activation of the cholinergic anti-inflammatory pathway via the activation of the vagus nerve.


Eligibility criteria: Inclusion Criteria:

* female patients and
* \> or = 18 years of age and
* diagnosed with breast cancer and
* undergoing radiation therapy and
* willing to follow protocol requirements

Exclusion Criteria:

* Stage IV disease or
* Presence of an underlying disease that is anticipated to be fatal w/in 6 mo
* Long term steroid medications in the past year or
* Plans to move out of study region within six months or
* Receiving regular body work over the past six months

Primary outcomes:
measure: Fatigue Symptom Inventory, Pittsburgh Sleep Quality Index, and Insomnia Severity Index scores over time.
timeFrame: Baseline, End of Treatment (6 weeks), End of Study (3 months after End of Treatment)
Secondary outcomes:
measure: Plasma levels of proinflammatory markers: interleukin-6 (IL-6), soluble IL-6 receptor (sIL-6R/CD126), and C-Reactive Protein (CRP).
timeFrame: Baseline, End of Treatment (6 weeks)
Other outcomes:
Locations:
city: New Albany
country: United States
facility: FMHHS Cancer Care Center
state: Indiana
Study officials:
affiliation: Indiana University Southeast
name: Judith G Myers, PhD
role: PRINCIPAL_INVESTIGATOR
References: