LeukemiaPhase 2NCT00792077
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 Phase 2 study testing Lenalidomide in people with Leukemia and CLL, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Lenalidomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to 3 Aug 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: 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.
Read the 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.
- Being tested
- Lenalidomide
- Keywords
- Leukemia, Lenalidomide, Actigraph, Sleep Test Study, Chronic Lymphocytic Leukemia, CC-5013, Revlimid
- Medical subject headings
- Leukemia, Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenalidomideDrug
Also called CC-5013, Revlimid
5 mg daily for 56 days.
| Study group | Role | What they receive |
|---|---|---|
| Sleep time | Experimental | Assessment of patients with chronic lymphocytic leukemia (CLL) experience severe cancer related fatigue (CRF):
Lenalidomide + Actigraph + Questionnaire + Sleep Test Receives: Drug: Lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Sleep Time as Measured by Polysomnography (PSG)
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.
Measured: before and after 1st cycle of Lenalidomide treatment, up to 8 weeks
Secondary outcomes (3)
The Functional Assessment of Chronic Illness Therapy-Fatigue Subscale Score
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.
Measured: before and after 1st cycle of Lenalidomide treatment, up to 8 weeks
Epwort Sleep Scale
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.
Measured: before and after 1st cycle of Lenalidomide treatment, up to 8 weeks
ECOG Performance Status
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.
Measured: before and after first cycle of Lenalidomide treatment, up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2008 (estimated)
- Study startNov 2008
- Primary completion3 Aug 2020
- Study completion3 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sriram Yennurajalingam, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00792077
- Sponsor's protocol ID
- 2007-0945
- Other IDs
- NCI-2012-01661
- Status last verified
- Jun 2021
- First submitted
- 13 Nov 2008
- Last updated
- 1 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00792077
- Acronym / sponsor ID
- 2007-0945
- Keywords
- Leukemia, Lenalidomide, Actigraph, Sleep Test Study, Chronic Lymphocytic Leukemia, CC-5013, Revlimid
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Nov 2008 (actual)
- Primary completion
- 3 Aug 2020 (actual)
- Study completion
- 3 Aug 2020 (actual)
- First posted
- 17 Nov 2008 (estimated)
- Results
- Posted 1 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sleep time | Experimental | Drug: LenalidomideAssessment of patients with chronic lymphocytic leukemia (CLL) experience severe cancer related fatigue (CRF): Lenalidomide + Actigraph + Questionnaire + Sleep Test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LenalidomideAlso: CC-5013, Revlimid5 mg daily for 56 days. | Drug | Sleep time |
Primary outcome
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.
3 secondary outcomes
The Functional Assessment of Chronic Illness Therapy-Fatigue Subscale Score
Time frame: 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
ECOG Performance Status
Time frame: before and after first cycle of Lenalidomide treatment, up to 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- The University of Texas M.D.Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sriram Yennurajalingam, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lenalidomide in people with Leukemia and CLL, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Sleep Time as Measured by Polysomnography (PSG) (time frame: before and after 1st cycle of Lenalidomide treatment, up to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2021.