Phase 2
Completed N=6
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
leukemia · CLL
Source: ClinicalTrials.gov NCT00792077 ↗
Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcomePrimary: Total Sleep Time as Measured by Polysomnography (PSG) — -25.5 Minutes
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Sleep Time as Measured by Polysomnography (PSG) |
-25.5 | — |
| SECONDARY The Functional Assessment of Chronic Illness Therapy-Fatigue Subscale Score |
4 | — |
| SECONDARY Epwort Sleep Scale |
-1 | — |
| SECONDARY ECOG Performance Status |
— | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00792077). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.