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Completed

NCT Number: NCT01983995

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Dyssomnias Fatigue Mental Disorders Neoplasms Neoplasms by Site Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

50 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Feasibility of conducting an actigraphy study with breast cancer patients

    Time frame: 3 months

    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.

Secondary outcomes

  1. Association between patient-reported sleep quality, fatigue, and pain and objective actigraphy measurements.

    Time frame: 3 months

    We will evaluate patterns of symptoms reported by subjects and the apparent impact of these symptoms on both daytime function and sleep quality.

  2. Change in pain, fatigue, sleep disturbance, and daytime activity with 3 months of aromatase inhibitor therapy

    Time frame: 3 Months

    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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Damon Runyon Cancer Research Foundation

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Nov 14, 2013
Registry last updated
Oct 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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