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A Pilot Study to Investigate the Effect of Cytotoxic Therapy and/or Radiotherapy on Cancer Related Sleep Disturbances in CLL and Breast Cancer Patients Experiencing Fatigue

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00792077
Recruitment Status : Active, not recruiting
First Posted : November 17, 2008
Last Update Posted : May 23, 2019
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
The goal of this clinical research study is to learn if treatments to kill cancer cells including lenalidomide and/or radiation therapy can help to control symptoms such as sleep problems and fatigue in patients with chronic lymphocytic leukemia (CLL) and/or breast cancer.

Condition or disease Intervention/treatment Phase
Leukemia CLL Drug: Lenalidomide Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Open Label Study to Investigate the Effect of Cytotoxic Therapy and/or Radiotherapy Including Lenalidomide on Cancer Related Sleep Disturbances in Chronic Lymphocytic Leukemia (CLL) and Breast Cancer Patients Experiencing Clinically Significant Fatigue
Actual Study Start Date : November 2008
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2020

Arm Intervention/treatment
Experimental: Sleep time

Assessment of patients with chronic lymphocytic leukemia (CLL) experience severe cancer related fatigue (CRF):

Lenalidomide + Actigraph + Questionnaire + Sleep Test

Drug: Lenalidomide
5 mg daily for 56 days.
Other Names:
  • CC-5013
  • Revlimid

Primary Outcome Measures :
  1. Total Sleep Time as measured by polysomnography (PSG) [ Time Frame: Before and after 1st cycle of Lenalidomide treatment (57days (+/- 3 days)) ]
    Sleep record scored by registered polysomnographic technologists according to the standard criteria of Rechtschaffen and Kales. Records scored for total sleep time, number of minutes of wake after sleep onset (WASO), number of awakenings, sleep latency, sleep efficiency, and percentages of stages 1,2,3,4, and REM sleep, as well as cortical arousals (defined as sudden increases in electroencephalogram frequency of at least 3 second duration, following at least 10 seconds of continuous sleep, with or without accompanying muscle activity).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Describe fatigue as being present every day for most of day for a minimum of 2 weeks and rate fatigue greater than or equal to 4 on a 0-10 scale, in which 0= no fatigue and 10=worst possible fatigue as assessed by MD Anderson symptom Inventory(MDASI).
  2. Have diagnoses of CLL and started on a new cytotoxic therapy or breast cancer receiving new cytotoxic or radiation therapy
  3. Patients will be eligible to participate in this study if they rate sleep disturbance greater than or equal to 4 on a 0-10 scale, in which 0= disturbed sleep is not present and 10 = disturbed sleep as bad as you can imagine as assessed by MDASI.
  4. Have a MDAS of 13 or less.
  5. Able to understand the description of the study and give written informed consent.

Exclusion Criteria:

  1. Patients who are unable to complete the assessment measures or refuse to participate
  2. Patients with known history of brain metastasis.
  3. Patients with known history of sleep apnea.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00792077

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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
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Principal Investigator: Sriram Yennurajalingam, MD M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00792077     History of Changes
Other Study ID Numbers: 2007-0945
NCI-2012-01661 ( Registry Identifier: NCI CTRP )
First Posted: November 17, 2008    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by M.D. Anderson Cancer Center:
Sleep Test Study
Chronic Lymphocytic Leukemia
Additional relevant MeSH terms:
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Sleep Wake Disorders
Neoplasms by Histologic Type
Signs and Symptoms
Nervous System Diseases
Mental Disorders
Neurologic Manifestations
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents