Status:
COMPLETED
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
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Leukemia
CLL
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Detailed Description
In this study, researchers are trying to learn if treatments to kill cancer cells such as lenalidomide and/or radiation therapy can also help to control sleep problems and fatigue in patients with CLL...
Eligibility Criteria
Inclusion
- 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).
- Have diagnoses of CLL and started on a new cytotoxic therapy or breast cancer receiving new cytotoxic or radiation therapy
- 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.
- Have a MDAS of 13 or less.
- Able to understand the description of the study and give written informed consent.
Exclusion
- Patients who are unable to complete the assessment measures or refuse to participate
- Patients with known history of brain metastasis.
- Patients with known history of sleep apnea.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 3 2020
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00792077
Start Date
November 1 2008
End Date
August 3 2020
Last Update
July 1 2021
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030