- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01983995
Examining the Relationships Between Sleep, Fatigue, and Pain in Aromatase Inhibitor-treated Patients
October 24, 2016 updated by: N. Lynn Henry, University of Michigan
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
49
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan Health System
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
University of Michigan Cancer Center
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Actigraphy
Postmenopausal women starting aromatase inhibitor therapy will undergo assessment with questionnaires and actigraphy before starting AI therapy and after 3 months of treatment.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility of conducting an actigraphy study with breast cancer patients
Time Frame: 3 months
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Feasibility will be measured by the proportion of breast cancer patients who are starting aromatase inhibitor therapy who complete baseline and 3 month assessment questionnaires and also enter actigraphy data correctly at least 85% of the time.
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3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Association between patient-reported sleep quality, fatigue, and pain and objective actigraphy measurements.
Time Frame: 3 months
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We will evaluate patterns of symptoms reported by subjects and the apparent impact of these symptoms on both daytime function and sleep quality.
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3 months
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Change in pain, fatigue, sleep disturbance, and daytime activity with 3 months of aromatase inhibitor therapy
Time Frame: 3 Months
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We will analyze the change in sleep, pain, fatigue, and symptom severity index between baseline and 12 weeks.
We will correlate changes in symptoms from baseline to 12 weeks with actigraphy activity.
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3 Months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Norah L Henry, MD, PhD, University of Michigan
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2013
Primary Completion (Actual)
September 1, 2016
Study Completion (Actual)
September 1, 2016
Study Registration Dates
First Submitted
November 7, 2013
First Submitted That Met QC Criteria
November 7, 2013
First Posted (Estimate)
November 14, 2013
Study Record Updates
Last Update Posted (Estimate)
October 25, 2016
Last Update Submitted That Met QC Criteria
October 24, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00078882
- UMCC 2013.098 (Other Identifier: University of Michigan Cancer Center)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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