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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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00792077
First received: November 13, 2008
Last updated: September 11, 2014
Last verified: September 2014
  Purpose

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 Intervention
Leukemia
CLL
Drug: Lenalidomide

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Total Sleep Time as measured by polysomnography (PSG) [ Time Frame: Before and after 1st cycle of Lenalidomide treatment (57days (+/- 3 days)) ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 12
Study Start Date: November 2008
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00792077

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

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00792077     History of Changes
Other Study ID Numbers: 2007-0945
Study First Received: November 13, 2008
Last Updated: September 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Leukemia
Lenalidomide
Actigraph
Sleep Test Study
Chronic Lymphocytic Leukemia
CC-5013
Revlimid

Additional relevant MeSH terms:
Breast Neoplasms
Dyssomnias
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Parasomnias
Sleep Disorders
Breast Diseases
Immune System Diseases
Immunoproliferative Disorders
Leukemia, B-Cell
Lymphatic Diseases
Lymphoproliferative Disorders
Mental Disorders
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Skin Diseases
Lenalidomide
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014