Examining the Relationships Between Sleep, Fatigue, and Pain in Aromatase Inhibitor-treated Patients
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 50 - Any |
| Updated: | 5/12/2016 |
| Start Date: | November 2013 |
| End Date: | December 2016 |
Prospective Pilot Study Evaluating the Inter-relationships Between Sleep Disturbance, Fatigue, Pain, and Daytime Activity in Breast Cancer Patients Starting Aromatase Inhibitor Therapy
Aromatase inhibitors are commonly prescribed for treatment of postmenopausal women with
breast cancer. These medications can cause side effects in some women, and occasionally they
can be quite bothersome. We are doing a study to better understand the side effects of
aromatase inhibitors so that we can hopefully treat them better or possibly prevent them. In
particular, we are interested in pain and difficulty sleeping. This study is designed to
assess the effect of aromatase inhibitors on pain, sleep quality, and fatigue and the
interplay of these side effects and their subsequent impact on daily activity. Each
participant will fill out a series of questionnaires about pain, sleep quality, and fatigue
and will also complete a sleep diary and wear an actigraphy watch for 10 days before
starting an aromatase inhibitor and after taking it for 3 months. We hope to learn more
about these symptoms so we can better manage medication toxicity in the future.
breast cancer. These medications can cause side effects in some women, and occasionally they
can be quite bothersome. We are doing a study to better understand the side effects of
aromatase inhibitors so that we can hopefully treat them better or possibly prevent them. In
particular, we are interested in pain and difficulty sleeping. This study is designed to
assess the effect of aromatase inhibitors on pain, sleep quality, and fatigue and the
interplay of these side effects and their subsequent impact on daily activity. Each
participant will fill out a series of questionnaires about pain, sleep quality, and fatigue
and will also complete a sleep diary and wear an actigraphy watch for 10 days before
starting an aromatase inhibitor and after taking it for 3 months. We hope to learn more
about these symptoms so we can better manage medication toxicity in the future.
Inclusion Criteria:
- Female, aged 50 years or older, postmenopausal.
- Patients with histologically proven stage 0-III invasive carcinoma of the breast that
is estrogen receptor and/or progesterone receptor positive by immunohistochemical
staining, who are planning to start treatment with a standard dose of aromatase
inhibitor (AI) therapy.
- Subjects must have undergone surgical resection of their primary tumor, as indicated.
The most recent surgery must have been performed at least 4 weeks before the baseline
evaluation and no additional surgeries (including reconstructive procedures) should
be planned during study participation.
- Cytoxic chemotherapy, if applicable, must have been completed at least 4 weeks before
the baseline evaluation.
- Radiation therapy, if applicable, must have been completed at least 2 weeks before
baseline evaluation.
- Eastern Cooperative Oncology Group performance status 0-2.
- Ability to operate the accelerometer
Exclusion Criteria:
- Diagnosis of sleep apnea or restless leg syndrome.
- Use of a wheelchair for ambulation most of the time.
- Second or third shift workers or other non-traditional sleep schedules.
- History of medical arthritic disease that could confound or interfere with evaluation
of pain or activity level, including but not limited to inflammatory arthritis
(rheumatoid arthritis, systemic lupus, spondyloarthropathy, psoriatic arthritis,
polymyalgia rheumatica), Parkinson's disease, and cancer involving the bone.
- Serious or unstable medical condition that could likely lead to hospitalization
during the course of the study or compromise study participation
We found this trial at
1
site
1500 E Medical Center Dr
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
(734) 936-4000
Phone: 800-865-1125
University of Michigan Health System The University of Michigan is home to one of the...
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