FatigueNCT00178204
Sleep Architecture and Chemotherapy-Related Fatigue
An observational study of Fatigue and Sleep, run by University of Rochester at 1 site in United States.
Trial summary
The purpose of this study is to identify specific chemotherapy-related changes in sleep stages/architecture that may relate to an increase in fatigue in individuals with cancer. The researchers hypothesize that the fatigue experienced by cancer patients receiving chemotherapy is in part due to changes in restorative… Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2004to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: patients beginning chemotherapy
Who may be able to join
- Have a diagnosis of cancer and not have had chemotherapy during the prior three years
- Be scheduled for chemotherapy that is expected to last at least 9 weeks but not more than 33 weeks without concurrent interferon treatment. Radiation therapy is allowed provided it is concluded within the 33 week time period
- Have a stable sleep/wake schedule (no shift work) with a preferred sleep phase between 10:00 PM and 9:00 AM
- Be 18 years of age or older
- Give informed consent
- If on beta blockers or being treated for depression or a thyroid disorder, the medication has been stable for 3 months
Who cannot join
- On a short term basis (less than 3 months), taking any prescription medication for the control of anxiety, sleep, depression, or fatigue OR taking any over-the-counter medications known to affect sleep
- Diagnosed with post-traumatic stress disorder (PTSD) or have a substance abuse disorder or psychotic disorder (currently or by history)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester James P. Wilmot Cancer Center
Rochester, New York, 14642
About this study
The purpose of this study is to identify specific chemotherapy-related changes in sleep stages/architecture that may relate to an increase in fatigue in individuals with cancer.
The researchers hypothesize that the fatigue experienced by cancer patients receiving chemotherapy is in part due to changes in restorative sleeping during the non-rapid eye movement cycles of sleep (i.e., delta activity).
Read the detailed description
Studies have shown a strong positive correlation between self-reported changes in sleep and cancer patients' fatigue, and also between an objective measure of sleep continuity, [i.e., actigraphy and polysomnography (PSG)] and self-reported fatigue. Chemotherapy disrupts normal sleep patterns, and fatigue, in the later stages of chemotherapy, may occur as a result of disturbed nocturnal sleep continuity. However, the causes of chemotherapy-related fatigue remain unknown, and whether or not abnormal sleep architecture contributes to this debilitating effect has yet to be explored. We believe that fatigue experienced by many cancer patients receiving chemotherapy is due, at least in part, to changes in delta activity [i.e., restorative sleep during the non-rapid eye movement (NREM) cycles of sleep]. A finding that slow wave sleep abnormalities play a significant role in fatigue would prompt further confirmatory studies and support controlled intervention studies.
Comparisons: In a clinical trial of individuals with cancer prior to, during, and after completion of chemotherapy, we will identify and compare specific chemotherapy-related changes in sleep stages/architecture that may relate to an increase in fatigue. These changes will be measured by actigraphy, PSG, and patient self-reporting techniques (e.g., sleep diaries, questionnaires).
The primary objective is to:
- examine the role of delta sleep in the development of chemotherapy-induced fatigue in cancer patients
Secondary objectives are to:
- characterize the involvement of other elements of sleep architecture [e.g., rapid eye movement (REM) sleep] and changes in sleep continuity relating to the development of chemotherapy-induced fatigue in cancer patients
- examine the role of sleep architecture in the persistence of chemotherapy-induced fatigue
- examine (in post hoc analyses) the relationship of various physical symptoms and patient variables that may be related to fatigue (e.g., pain, hot flashes, anxiety, hemoglobin, menopausal status, sleep continuity, and QOL) and to each other, both during and following chemotherapy.
Answers to these questions will provide information that will be helpful in developing potential targets for interventions to reduce fatigue.
- Keywords
- delta sleep, Cancer-related fatigue, Sleep Disturbance, chemotherapy
- Medical subject headings
- Fatigue, Neoplasms, Parasomnias
What is being measured
The primary outcome is the main question the study is designed to answer.
Polysomnography (PSG)
Polysomnography provides direct and quantitative measures of cortical activity during sleep (in the form of brain waves). The sleep continuity data derived from this technique include sleep latency (time taken to fall asleep), wake after sleep onset time, total sleep time, and sleep efficiency (SE). The sleep architecture information derived from this technique consists of the assessment of sleep in terms of its constituent component stages (i.e., percent Stage-1, Stage-2, SWS, and REM sleep).
Measured: Two consecutive nights prior to first chemotherapy, approximately three weeks following the patient's last chemotherapy, and three months following the last treatment.
Secondary outcomes (1)
Brief Fatigue Inventory (BFI)
The Brief Fatigue Inventory is a 9-item, patient-report instrument with established reliability and validity that allows for the rapid assessment of fatigue level in cancer patients. Possible scores on this scale range from 0 - 10 with higher numbers indicating greater fatigue.
Measured: On the first night of each of the three polysomnography assessments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startNov 2004
- Primary completionMay 2009
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Principal investigator, Joseph Roscoe, University of Rochester
- Investigators
- Joesph A Roscoe, Ph.D., Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00178204
- Sponsor's protocol ID
- MRSG-04-233-01-CPPB
- Status last verified
- Dec 2014
- First submitted
- 12 Sep 2005
- Last updated
- 5 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Architecture and Chemotherapy-Related Fatigue
- ClinicalTrials.gov ID
- NCT00178204
- Acronym / sponsor ID
- MRSG-04-233-01-CPPB
- Keywords
- delta sleep, Cancer-related fatigue, Sleep Disturbance, chemotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- Nov 2004
- Primary completion
- May 2009 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to identify specific chemotherapy-related changes in sleep stages/architecture that may relate to an increase in fatigue in individuals with cancer.
The researchers hypothesize that the fatigue experienced by cancer patients receiving chemotherapy is in part due to changes in restorative sleeping during the non-rapid eye movement cycles of sleep (i.e., delta activity).
Detailed description
Studies have shown a strong positive correlation between self-reported changes in sleep and cancer patients' fatigue, and also between an objective measure of sleep continuity, [i.e., actigraphy and polysomnography (PSG)] and self-reported fatigue. Chemotherapy disrupts normal sleep patterns, and fatigue, in the later stages of chemotherapy, may occur as a result of disturbed nocturnal sleep continuity. However, the causes of chemotherapy-related fatigue remain unknown, and whether or not abnormal sleep architecture contributes to this debilitating effect has yet to be explored. We believe that fatigue experienced by many cancer patients receiving chemotherapy is due, at least in part, to changes in delta activity [i.e., restorative sleep during the non-rapid eye movement (NREM) cycles of sleep]. A finding that slow wave sleep abnormalities play a significant role in fatigue would prompt further confirmatory studies and support controlled intervention studies.
Comparisons: In a clinical trial of individuals with cancer prior to, during, and after completion of chemotherapy, we will identify and compare specific chemotherapy-related changes in sleep stages/architecture that may relate to an increase in fatigue. These changes will be measured by actigraphy, PSG, and patient self-reporting techniques (e.g., sleep diaries, questionnaires).
The primary objective is to:
- examine the role of delta sleep in the development of chemotherapy-induced fatigue in cancer patients
Secondary objectives are to:
- characterize the involvement of other elements of sleep architecture [e.g., rapid eye movement (REM) sleep] and changes in sleep continuity relating to the development of chemotherapy-induced fatigue in cancer patients
- examine the role of sleep architecture in the persistence of chemotherapy-induced fatigue
- examine (in post hoc analyses) the relationship of various physical symptoms and patient variables that may be related to fatigue (e.g., pain, hot flashes, anxiety, hemoglobin, menopausal status, sleep continuity, and QOL) and to each other, both during and following chemotherapy.
Answers to these questions will provide information that will be helpful in developing potential targets for interventions to reduce fatigue.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients beginning chemotherapy
Key inclusion criteria (6 listed)
- Have a diagnosis of cancer and not have had chemotherapy during the prior three years
- Be scheduled for chemotherapy that is expected to last at least 9 weeks but not more than 33 weeks without concurrent interferon treatment. Radiation therapy is allowed provided it is concluded within the 33 week time period
- Have a stable sleep/wake schedule (no shift work) with a preferred sleep phase between 10:00 PM and 9:00 AM
- Be 18 years of age or older
- Give informed consent
Key exclusion criteria (2 listed)
- On a short term basis (less than 3 months), taking any prescription medication for the control of anxiety, sleep, depression, or fatigue OR taking any over-the-counter medications known to affect sleep
- Diagnosed with post-traumatic stress disorder (PTSD) or have a substance abuse disorder or psychotic disorder (currently or by history)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Polysomnography (PSG)
Time frame: Two consecutive nights prior to first chemotherapy, approximately three weeks following the patient's last chemotherapy, and three months following the last treatment.
Polysomnography provides direct and quantitative measures of cortical activity during sleep (in the form of brain waves). The sleep continuity data derived from this technique include sleep latency (time taken to fall asleep), wake after sleep onset time, total sleep time, and sleep efficiency (SE). The sleep architecture information derived from this technique consists of the assessment of sleep in terms of its constituent component stages (i.e., percent Stage-1, Stage-2, SWS, and REM sleep).
1 secondary outcome
Brief Fatigue Inventory (BFI)
Time frame: On the first night of each of the three polysomnography assessments
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2014.
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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.
Joesph A Roscoe, Ph.D. principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fatigue and Sleep, run by University of Rochester 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 6 inclusion and 2 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 5 Dec 2014. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Polysomnography (PSG) (time frame: Two consecutive nights prior to first chemotherapy, approximately three weeks following the patient's last chemotherapy, and three months following the last treatment.). 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 5 Dec 2014.