Breast CancerCHRONONCT04401189
The Role of Circadian Rhythms in Cancer-Related Symptoms
An observational study of Breast Cancer and Fatigue, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
Emerging evidence indicates that circadian rhythms may be disrupted following cancer and its treatment, and that circadian rhythm disruption may be an underlying pathophysiological mechanism of cancer- and cancer treatment-related symptoms (CRS) such as fatigue, sleep disturbance, cognitive impairment, and depressed… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Fatigue, Cognitive Impairment
- How many people
- 124 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jun 2020to 30 Jun 2023
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Newly diagnosed breast cancer patients. Controls will be healthy volunteers of cancer-free women matched on age.
Who may be able to join
- Patients with early breast cancer scheduled for surgery and chemotherapy (neoadjuvant or adjuvant) at Aarhus University Hospital (AUH).
- The healthy control group will consist of an age-matched sample of participants with no history of cancer.
Who cannot join
- Pregnancy
- Shift-work
- Melatonin supplementation
- Insufficient Danish proficiency
- Previous cancer diagnosis except for treated non-melanoma skin cancer
- Confounding diagnosed or suspected psychiatric or medical conditions that might significantly contribute to the CRS or symptoms/diagnoses resembling them (other than those caused by cancer or its treatment) such as seasonal affective disorder.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Circadian Rhythms in Cancer-Related Symptoms: A Prospective Controlled Chrono-Bio-Behavioral Observation Study
Emerging evidence indicates that circadian rhythms may be disrupted following cancer and its treatment, and that circadian rhythm disruption may be an underlying pathophysiological mechanism of cancer- and cancer treatment-related symptoms (CRS) such as fatigue, sleep disturbance, cognitive impairment, and depressed mood. Given the detrimental effect of CRS on cancer survivors' quality of life, and a pressing demand for effective interventions to treat CRS, there is a need for a comprehensive examination of circadian disruption related to cancer and its treatment, and its association with CRS. The study will prospectively examine circadian rhythms and a CRS composite score in recently diagnosed breast cancer patients from prior to surgery or chemotherapy to 12 months later. A matched healthy control group will serve as a comparison.
- Conditions
- Breast Cancer, Fatigue, Cognitive Impairment, Sleep, Depression, Quality of Life
- Keywords
- Breast cancer, Circadian rhythms disruption, Cancer-related symptoms
- Medical subject headings
- Breast Neoplasms, Fatigue, Cognitive Dysfunction, Depression, Stress, Psychological, Inflammation, Chronobiology Disorders, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer patients | Not described | |
| Healthy controls | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cancer related symptoms composite score change
A composite score will be calculated based on measures of fatigue, sleep, cognition, and depression as described under secondary outcomes
Measured: Change from baseline to time 2 (an average of 1 month)
Cancer related symptoms composite score change
A composite score will be calculated based on measures of fatigue, sleep, cognition, and depression as described under secondary outcomes
Measured: Change from baseline to time 3 (an average of 6 months)
Cancer related symptoms composite score change
A composite score will be calculated based on measures of fatigue, sleep, cognition, and depression as described under secondary outcomes
Measured: Change from baseline to time 4 (through study completion, an average of 1 year)
Circadian Activity Rhythms change
Rest/wake activity recorded with wrist actigraphy
Measured: Change from baseline to time 2 (an average of 1 month)
Circadian Activity Rhythms change
Rest/wake activity recorded with wrist actigraphy
Measured: Change from baseline to time 3 (an average of 6 months)
Circadian Activity Rhythms change
Rest/wake activity recorded with wrist actigraphy
Measured: Change from baseline to time 4 (through study completion, an average of 1 year)
Circadian skin temperature change
Distal skin temperature recorded with wrist actigraphy
Measured: Change from baseline to time 2 (an average of 1 month)
Circadian skin temperature change
Distal skin temperature recorded with wrist actigraphy
Measured: Change from baseline to time 3 (an average of 6 months)
Circadian skin temperature change
Distal skin temperature recorded with wrist actigraphy
Measured: Change from baseline to time 4 (through study completion, an average of 1 year)
Dim light melatonin onset change
Melatonin based on saliva samples
Measured: Change from baseline to time 4 (through study completion, an average of 1 year)
Secondary outcomes (28)
Cognitive functioning change
Standard neuropsychological test battery
Measured: Change from baseline to time 3 (an average of 6 months)
Cognitive functioning change
Standard neuropsychological test battery
Measured: Change from baseline to time 4 (through study completion, an average of 1 year)
Cancer-related fatigue change
FACIT fatigue
Measured: Change from baseline to time 2 (an average of 1 month)
Cancer-related fatigue change
FACIT fatigue
Measured: Change from baseline to time 3 (an average of 6 months)
Cancer-related fatigue change
FACIT fatigue
Measured: Change from baseline to time 4 (through study completion, an average of 1 year)
Sleep change
Objective sleep recorded with wrist actigraphy
Measured: Change from baseline to time 2 (an average of 1 month)
Sleep change
Objective sleep recorded with wrist actigraphy
Measured: Change from baseline to time 3 (an average of 6 months)
Sleep change
Objective sleep recorded with wrist actigraphy
Measured: Change from baseline to time 4 (through study completion, an average of 1 year)
Inflammatory markers change
Proinflammatory cytokines known to mediate chronic inflammatory processes. Extracted from blood samples.
Measured: Change from baseline to time 3 (an average of 6 months)
Inflammatory markers change
Proinflammatory cytokines known to mediate chronic inflammatory processes. Extracted from blood samples.
Measured: Change from baseline to time 4 (through study completion, an average of 1 year)
Stress change
Perceived Stress Scale (PSS)
Measured: Change from baseline to time 2 (an average of 1 month)
Stress change
PSS
Measured: Change from baseline to time 3 (an average of 6 months)
Stress change
PSS
Measured: Change from baseline to time 4 (through study completion, an average of 1 year)
Sleep quality change
Pittsburgh sleep quality index
Measured: Change from baseline to time 2 (an average of 1 month)
Sleep quality change
Pittsburgh sleep quality index
Measured: Change from baseline to time 3 (an average of 6 months)
Sleep quality change
Pittsburgh sleep quality index
Measured: Change from baseline to time 4 (through study completion, an average of 1 year)
Insomnia change
Insomnia Severity Index
Measured: Change from baseline to time 2 (an average of 1 month)
Insomnia change
Insomnia Severity Index
Measured: Change from baseline to time 3 (an average of 6 months)
Insomnia change
Insomnia Severity Index
Measured: Change from baseline to time 4 (through study completion, an average of 1 year)
Self-reported cognitive functioning change
Functional Assessment of Cancer Therapy - Cognitive function issues (FACT-Cog)
Measured: Change from baseline to time 2 (an average of 1 month)
Self-reported cognitive functioning change
FACT-Cog
Measured: Change from baseline to time 3 (an average of 6 months)
Self-reported cognitive functioning change
FACT-Cog
Measured: Change from baseline to time 4 (through study completion, an average of 1 year)
Depression change
Center for Epidemiologic Studies Depression Scale (CESD)
Measured: Change from baseline to time 2 (an average of 1 month)
Depression change
CESD
Measured: Change from baseline to time 3 (an average of 6 months)
Depression change
CESD
Measured: Change from baseline to time 4 (through study completion, an average of 1 year)
Self-reported quality of life change
Short Form 36 (SF36)
Measured: Change from baseline to time 2 (an average of 1 month)
Self-reported quality of life change
SF36
Measured: Change from baseline to time 3 (an average of 6 months)
Self-reported quality of life change
SF36
Measured: Change from baseline to time 4 (through study completion, an average of 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2020
- Study start1 Jun 2020
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe 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
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aarhus, Danish Cancer Society
- Responsible party
- Principal investigator, Ali Amidi, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04401189
- Sponsor's protocol ID
- 2016-051-000001- 1731
- Acronym
- CHRONO
- Status last verified
- Jun 2024
- First submitted
- 19 Apr 2020
- Last updated
- 28 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Circadian Rhythms in Cancer-Related Symptoms: A Prospective Controlled Chrono-Bio-Behavioral Observation Study
- ClinicalTrials.gov ID
- NCT04401189
- Acronym / sponsor ID
- CHRONO / 2016-051-000001- 1731
- Conditions
- Breast Cancer, Fatigue, Cognitive Impairment, Sleep, Depression, Quality of Life
- Keywords
- Breast cancer, Circadian rhythms disruption, Cancer-related symptoms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- University of Aarhus, Danish Cancer Society
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 26 May 2020 (actual)
- 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.
Emerging evidence indicates that circadian rhythms may be disrupted following cancer and its treatment, and that circadian rhythm disruption may be an underlying pathophysiological mechanism of cancer- and cancer treatment-related symptoms (CRS) such as fatigue, sleep disturbance, cognitive impairment, and depressed mood. Given the detrimental effect of CRS on cancer survivors' quality of life, and a pressing demand for effective interventions to treat CRS, there is a need for a comprehensive examination of circadian disruption related to cancer and its treatment, and its association with CRS. The study will prospectively examine circadian rhythms and a CRS composite score in recently diagnosed breast cancer patients from prior to surgery or chemotherapy to 12 months later. A matched healthy control group will serve as a comparison.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast cancer patients | – | – |
| Healthy controls | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Newly diagnosed breast cancer patients. Controls will be healthy volunteers of cancer-free women matched on age.
Key inclusion criteria (2 listed)
- Patients with early breast cancer scheduled for surgery and chemotherapy (neoadjuvant or adjuvant) at Aarhus University Hospital (AUH).
- The healthy control group will consist of an age-matched sample of participants with no history of cancer.
Key exclusion criteria (6 listed)
- Pregnancy
- Shift-work
- Melatonin supplementation
- Insufficient Danish proficiency
- Previous cancer diagnosis except for treated non-melanoma skin cancer
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
Cancer related symptoms composite score change
Time frame: Change from baseline to time 2 (an average of 1 month)
A composite score will be calculated based on measures of fatigue, sleep, cognition, and depression as described under secondary outcomes
Cancer related symptoms composite score change
Time frame: Change from baseline to time 3 (an average of 6 months)
A composite score will be calculated based on measures of fatigue, sleep, cognition, and depression as described under secondary outcomes
Cancer related symptoms composite score change
Time frame: Change from baseline to time 4 (through study completion, an average of 1 year)
A composite score will be calculated based on measures of fatigue, sleep, cognition, and depression as described under secondary outcomes
Circadian Activity Rhythms change
Time frame: Change from baseline to time 2 (an average of 1 month)
Rest/wake activity recorded with wrist actigraphy
Circadian Activity Rhythms change
Time frame: Change from baseline to time 3 (an average of 6 months)
Rest/wake activity recorded with wrist actigraphy
Circadian Activity Rhythms change
Time frame: Change from baseline to time 4 (through study completion, an average of 1 year)
Rest/wake activity recorded with wrist actigraphy
Circadian skin temperature change
Time frame: Change from baseline to time 2 (an average of 1 month)
Distal skin temperature recorded with wrist actigraphy
Circadian skin temperature change
Time frame: Change from baseline to time 3 (an average of 6 months)
Distal skin temperature recorded with wrist actigraphy
Circadian skin temperature change
Time frame: Change from baseline to time 4 (through study completion, an average of 1 year)
Distal skin temperature recorded with wrist actigraphy
Dim light melatonin onset change
Time frame: Change from baseline to time 4 (through study completion, an average of 1 year)
Melatonin based on saliva samples
28 secondary outcomes
Cognitive functioning change
Time frame: Change from baseline to time 3 (an average of 6 months)
Cognitive functioning change
Time frame: Change from baseline to time 4 (through study completion, an average of 1 year)
Cancer-related fatigue change
Time frame: Change from baseline to time 2 (an average of 1 month)
Cancer-related fatigue change
Time frame: Change from baseline to time 3 (an average of 6 months)
Cancer-related fatigue change
Time frame: Change from baseline to time 4 (through study completion, an average of 1 year)
Sleep change
Time frame: Change from baseline to time 2 (an average of 1 month)
Sleep change
Time frame: Change from baseline to time 3 (an average of 6 months)
Sleep change
Time frame: Change from baseline to time 4 (through study completion, an average of 1 year)
Inflammatory markers change
Time frame: Change from baseline to time 3 (an average of 6 months)
Inflammatory markers change
Time frame: Change from baseline to time 4 (through study completion, an average of 1 year)
Stress change
Time frame: Change from baseline to time 2 (an average of 1 month)
Stress change
Time frame: Change from baseline to time 3 (an average of 6 months)
Stress change
Time frame: Change from baseline to time 4 (through study completion, an average of 1 year)
Sleep quality change
Time frame: Change from baseline to time 2 (an average of 1 month)
Sleep quality change
Time frame: Change from baseline to time 3 (an average of 6 months)
Sleep quality change
Time frame: Change from baseline to time 4 (through study completion, an average of 1 year)
Insomnia change
Time frame: Change from baseline to time 2 (an average of 1 month)
Insomnia change
Time frame: Change from baseline to time 3 (an average of 6 months)
Insomnia change
Time frame: Change from baseline to time 4 (through study completion, an average of 1 year)
Self-reported cognitive functioning change
Time frame: Change from baseline to time 2 (an average of 1 month)
Self-reported cognitive functioning change
Time frame: Change from baseline to time 3 (an average of 6 months)
Self-reported cognitive functioning change
Time frame: Change from baseline to time 4 (through study completion, an average of 1 year)
Depression change
Time frame: Change from baseline to time 2 (an average of 1 month)
Depression change
Time frame: Change from baseline to time 3 (an average of 6 months)
Depression change
Time frame: Change from baseline to time 4 (through study completion, an average of 1 year)
Self-reported quality of life change
Time frame: Change from baseline to time 2 (an average of 1 month)
Self-reported quality of life change
Time frame: Change from baseline to time 3 (an average of 6 months)
Self-reported quality of life change
Time frame: Change from baseline to time 4 (through study completion, an average of 1 year)
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 28 Jun 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Breast Cancer and Fatigue, run by Aarhus University Hospital at 1 site in Denmark.
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 2 inclusion and 6 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 28 Jun 2024. 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 Denmark. 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?
Cancer related symptoms composite score change (time frame: Change from baseline to time 2 (an average of 1 month)). The study lists 10 primary outcomes in all. 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 28 Jun 2024.