The Role of Circadian Rhythms in Cancer-Related Symptoms (CHRONO)

June 27, 2024 updated by: Ali Amidi, Aarhus University Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
124

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Ali Amidi, PhD
  • Phone Number: (+45) 8716 5305
  • Email: ali@psy.au.dk

Study Contact Backup

Study Locations

  • Denmark
      • Aarhus, Denmark, 8200
        • Aarhus University Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Newly diagnosed breast cancer patients. Controls will be healthy volunteers of cancer-free women matched on age.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Healthy controls
Breast cancer patients

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Change from baseline to time 2 (an average of 1 month)
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
Change from baseline to time 3 (an average of 6 months)
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
Change from baseline to time 4 (through study completion, an average of 1 year)
Circadian Activity Rhythms change
Time Frame: Change from baseline to time 2 (an average of 1 month)
Rest/wake activity recorded with wrist actigraphy
Change from baseline to time 2 (an average of 1 month)
Circadian Activity Rhythms change
Time Frame: Change from baseline to time 3 (an average of 6 months)
Rest/wake activity recorded with wrist actigraphy
Change from baseline to time 3 (an average of 6 months)
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
Change from baseline to time 4 (through study completion, an average of 1 year)
Circadian skin temperature change
Time Frame: Change from baseline to time 2 (an average of 1 month)
Distal skin temperature recorded with wrist actigraphy
Change from baseline to time 2 (an average of 1 month)
Circadian skin temperature change
Time Frame: Change from baseline to time 3 (an average of 6 months)
Distal skin temperature recorded with wrist actigraphy
Change from baseline to time 3 (an average of 6 months)
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
Change from baseline to time 4 (through study completion, an average of 1 year)
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
Change from baseline to time 4 (through study completion, an average of 1 year)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cognitive functioning change
Time Frame: Change from baseline to time 3 (an average of 6 months)
Standard neuropsychological test battery
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)
Standard neuropsychological test battery
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)
FACIT fatigue
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)
FACIT fatigue
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)
FACIT fatigue
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)
Objective sleep recorded with wrist actigraphy
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)
Objective sleep recorded with wrist actigraphy
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)
Objective sleep recorded with wrist actigraphy
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)
Proinflammatory cytokines known to mediate chronic inflammatory processes. Extracted from blood samples.
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)
Proinflammatory cytokines known to mediate chronic inflammatory processes. Extracted from blood samples.
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)
Perceived Stress Scale (PSS)
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)
PSS
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)
PSS
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)
Pittsburgh sleep quality index
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)
Pittsburgh sleep quality index
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)
Pittsburgh sleep quality index
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 Severity Index
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 Severity Index
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)
Insomnia Severity Index
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)
Functional Assessment of Cancer Therapy - Cognitive function issues (FACT-Cog)
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)
FACT-Cog
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)
FACT-Cog
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)
Center for Epidemiologic Studies Depression Scale (CESD)
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)
CESD
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)
CESD
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)
Short Form 36 (SF36)
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)
SF36
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)
SF36
Change from baseline to time 4 (through study completion, an average of 1 year)

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aarhus University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Aarhus
Danish Cancer Society

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 19, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 26, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 28, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2016-051-000001- 1731

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

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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