Overview

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

Status:
Completed
Trial end date:
2020-08-03
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Treatments:
Lenalidomide
Thalidomide
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.