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

June 30, 2021 updated by: M.D. Anderson Cancer Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 and/or breast cancer.

Study Procedures:

If you are found to be eligible to take part in this study, before you begin taking chemotherapy on Day 1, the following tests and procedures will be performed:

  • Blood (about 2 tablespoons) will be drawn to learn about the relationship between changes in specific protein levels in the blood, your level of fatigue, and sleep problems.
  • Your complete medical history will be recorded.
  • You will have a physical exam.
  • You will also complete 4 questionnaires that will ask you questions about your symptoms and your sleep patterns. They will take 20-30 minutes to complete in total.

From Day 1 through the end of 1st cycle (+/- 3 days), you will wear a watch that records your body movements. This is called an actigraph.

On Day 15 (+/- 3 days), you will be called by a member of the research staff. During these calls, you will complete the 4 questionnaires that ask about symptoms you are having and about your sleep patterns.

On Day 29 (+/- 3 days) and end of 1st cycle (+/- 3 days), you will have a clinic visit. At this visit, you will complete the 4 questionnaires that ask about symptoms you are having and your sleep patterns. Blood (about 2 tablespoons) will also be drawn to learn about the relationship between changes in protein levels in the blood, your level of fatigue, and sleep problems.

Sleep Tests:

You will have a sleep test before starting chemotherapy on Day 1 and again on end of 1st cycle (+/- 3 days). The sleep test is done overnight in a sleep lab.

A sleep study, called a polysomnogram, is a test that records a person's physical state during various stages of sleep and wakefulness. The study provides information about a person's sleep stages, body position, blood oxygen levels, breathing events, muscle tone, heart rate, snoring, and general sleep behavior.

When you arrive at the Sleep Center Laboratory you will be shown to your private room. You will complete a questionnaire that will ask questions about how much you slept the night before, how active you have been, and about any caffeine or alcohol you may have had. The questionnaire will take about 5 minutes to complete.

The member of the sleep lab staff will connect sensors that will record your brain waves, muscle tone, eye movements, air flow, and limb movements while you sleep. The sensors are applied to specific areas of your body with paste and gauze or tape. The monitoring equipment is painless and should not interfere with your sleep.

It is not a problem to have a drink of water or to use the restroom during the sleep study. The member of the sleep lab staff will monitor the sleep study from another room throughout the night and will wake you in the morning to remove the sensors.

In the morning, you will complete a questionnaire about how you slept and how you are feeling. It will take about 5 minutes to complete.

Length of Study:

You will be on study up to end of 1st cycle (+/- 3 days).

This is an investigational study. Sleep studies are a standard test for patients with sleep problems.

The blood tests performed for this study and the sleep test will be performed at no cost to you.

Up to 12 patients will take part in this study. All will be enrolled at M. D. Anderson.

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sleep time

Assessment of 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Sleep Time as Measured by Polysomnography (PSG)
Time Frame: before and after 1st cycle of Lenalidomide treatment, up to 8 weeks
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.
before and after 1st cycle of Lenalidomide treatment, up to 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Functional Assessment of Chronic Illness Therapy-Fatigue Subscale Score
Time Frame: before and after 1st cycle of Lenalidomide treatment, up to 8 weeks
The FACIT-F subscale is a validated measure of fatigue. In the FACIT-F, the patient rates the intensity of their fatigue and its related symptoms on a scale of 0 to 4. The total score can range between 0 and 52, with higher scores denoting less fatigue. The score 0= worst fatigue possible, 52 indicates no fatigue. The scores reported is the median (IQR) change at 8 weeks compared to baseline.
before and after 1st cycle of Lenalidomide treatment, up to 8 weeks
Epwort Sleep Scale
Time Frame: before and after 1st cycle of Lenalidomide treatment, up to 8 weeks
The Epworth sleep scale is an 8-item questionnaire designed to asses general level of daytime sleepiness, and scores on this instrument range form 0-24, with higher scores indicating greater sleepiness. It was measured as a change in total score between the before and after 1st cycle of treatment with Lenalidomide.
before and after 1st cycle of Lenalidomide treatment, up to 8 weeks
ECOG Performance Status
Time Frame: before and after first cycle of Lenalidomide treatment, up to 8 weeks
This criteria is used to assess how a patient's disease is progressing and to assess how the disease affects the daily living abilities of the patient. The scores on this instrument range from 0-5 (0=fully active and 5=dead), with higher scores indicating poorer performance. It was measured as a change in performance status between before and after 1st cycle of treatment with Lenalidomide.
before and after first cycle of Lenalidomide treatment, up to 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2008

Primary Completion (Actual)

August 3, 2020

Study Completion (Actual)

August 3, 2020

Study Registration Dates

First Submitted

November 13, 2008

First Submitted That Met QC Criteria

November 13, 2008

First Posted (Estimate)

November 17, 2008

Study Record Updates

Last Update Posted (Actual)

July 1, 2021

Last Update Submitted That Met QC Criteria

June 30, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-0945
  • NCI-2012-01661 (Registry Identifier: NCI CTRP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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