Clinical trial · Interventional
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
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| CLL | Chronic Lymphocytic Leukemia | ALIAS | 0.90 |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lenalidomide | Drug | Lenalidomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sleep time
- description
- Assessment of patients with chronic lymphocytic leukemia (CLL) experience severe cancer related fatigue (CRF): Lenalidomide + Actigraph + Questionnaire + Sleep Test
- interventionNames
- Drug: Lenalidomide
Primary outcomes (1)
- measure
- Total Sleep Time as Measured by Polysomnography (PSG)
- timeFrame
- before and after 1st cycle of Lenalidomide treatment, up to 8 weeks
- description
- Polysomnography (PSG) was done to measure the total sleep time in minutes. It was measured as a change in total sleep time between the before and after 1st cycle of treatment with Lenalidomide.
Secondary outcomes (3)
- measure
- The Functional Assessment of Chronic Illness Therapy-Fatigue Subscale Score
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available