Examining the Relationships Between Sleep, Fatigue, and Pain in Aromatase Inhibitor-treated Patients

Breast Cancer Clinical Trial

Official title:

Prospective Pilot Study Evaluating the Inter-relationships Between Sleep Disturbance, Fatigue, Pain, and Daytime Activity in Breast Cancer Patients Starting Aromatase Inhibitor Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01983995
• Other study ID #: HUM00078882
• Secondary ID: UMCC 2013.098
• Status: Completed
• Phase: N/A
• First received: November 7, 2013
• Last updated: October 24, 2016
• Start date: November 2013
• Est. completion date: September 2016

Study information

• Verified date: October 2016
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Fatigue

Locations

Country	Name	City	State
United States	University of Michigan Health System	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Damon Runyon Cancer Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of conducting an actigraphy study with breast cancer patients	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.	3 months	No
Secondary	Association between patient-reported sleep quality, fatigue, and pain and objective actigraphy measurements.	We will evaluate patterns of symptoms reported by subjects and the apparent impact of these symptoms on both daytime function and sleep quality.	3 months	No
Secondary	Change in pain, fatigue, sleep disturbance, and daytime activity with 3 months of aromatase inhibitor therapy	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.	3 Months	No