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

April 9, 2021 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

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

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

  • Name: Ali Amidi, PhD
  • Phone Number: (+45) 8716 5305
  • Email: ali@psy.au.dk

Study Contact Backup

Study Locations

  • Denmark
      • Aarhus, Denmark, 8200
        • Recruiting
        • Aarhus University Hospital
        • Contact:
          • Ali Amidi, PhD

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

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
Healthy controls
Breast cancer patients

What is the study measuring?

Primary Outcome Measures

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

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

Aarhus University Hospital

Collaborators

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)

June 1, 2020

Primary Completion (Anticipated)

June 1, 2022

Study Completion (Anticipated)

June 1, 2022

Study Registration Dates

First Submitted

April 19, 2020

First Submitted That Met QC Criteria

May 20, 2020

First Posted (Actual)

May 26, 2020

Study Record Updates

Last Update Posted (Actual)

April 14, 2021

Last Update Submitted That Met QC Criteria

April 9, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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