The Role of Circadian Rhythms in Cancer-Related Symptoms
CHRONO
1 other identifier
observational
124
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 19, 2020
CompletedFirst Posted
Study publicly available on registry
May 26, 2020
CompletedStudy Start
First participant enrolled
June 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2023
CompletedJune 28, 2024
June 1, 2024
3.1 years
April 19, 2020
June 27, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (10)
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
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
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
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
Change from baseline to time 2 (an average of 1 month)
Circadian Activity Rhythms change
Rest/wake activity recorded with wrist actigraphy
Change from baseline to time 3 (an average of 6 months)
Circadian Activity Rhythms change
Rest/wake activity recorded with wrist actigraphy
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
Change from baseline to time 2 (an average of 1 month)
Circadian skin temperature change
Distal skin temperature recorded with wrist actigraphy
Change from baseline to time 3 (an average of 6 months)
Circadian skin temperature change
Distal skin temperature recorded with wrist actigraphy
Change from baseline to time 4 (through study completion, an average of 1 year)
Dim light melatonin onset change
Melatonin based on saliva samples
Change from baseline to time 4 (through study completion, an average of 1 year)
Secondary Outcomes (28)
Cognitive functioning change
Change from baseline to time 3 (an average of 6 months)
Cognitive functioning change
Change from baseline to time 4 (through study completion, an average of 1 year)
Cancer-related fatigue change
Change from baseline to time 2 (an average of 1 month)
Cancer-related fatigue change
Change from baseline to time 3 (an average of 6 months)
Cancer-related fatigue change
Change from baseline to time 4 (through study completion, an average of 1 year)
- +23 more secondary outcomes
Study Arms (2)
Breast cancer patients
Healthy controls
Eligibility Criteria
Newly diagnosed breast cancer patients. Controls will be healthy volunteers of cancer-free women matched on age.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aarhus University Hospitallead
- University of Aarhuscollaborator
- Danish Cancer Societycollaborator
Study Sites (1)
Aarhus University Hospital
Aarhus, 8200, Denmark
Biospecimen
Saliva samples for melatonin. Blood samples for inflammatory cytokines.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
April 19, 2020
First Posted
May 26, 2020
Study Start
June 1, 2020
Primary Completion
June 30, 2023
Study Completion
June 30, 2023
Last Updated
June 28, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will not share