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Study Role of Lenalidomide in Improving Sleep in CLL Patients 65+ Years Experiencing Clinically Significant 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 10, 2012
Last verified: September 2012
History of Changes
  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 Role of Lenalidomide in Improving Cancer Related Sleep in CLL Patients Over 65 Years of Age Experiencing Clinically Significant Fatigue

Resource links provided by NLM:

U.S. FDA Resources

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 ]

Estimated Enrollment: 12
Study Start Date: November 2008
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sleep time

Assessment of Elderly 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:   65 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00792077

Locations
United States, Texas
UT 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:
The University of Texas M.D.Anderson Cancer Center  This link exits the ClinicalTrials.gov site

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 10, 2012
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:
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lenalidomide
Thalidomide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
 Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on May 23, 2013