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Completed

NCT Number: NCT04401189

The Role of Circadian Rhythms in Cancer-Related Symptoms

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.

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Key information

Conditions

Breast Cancer Behavior Behavioral Symptoms Breast Diseases Breast Neoplasms Cancer-Related Syndrome Chronobiology Disorders Circadian Rhythm Disorders Cognition Disorders Cognitive Dysfunction Cognitive Impairment Depression Fatigue Inflammation Mental Disorders Neoplasms Neoplasms by Site Nervous System Diseases Neurocognitive Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Quality of Life Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases Sleep Stress, Psychological

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Aarhus University Hospital

Aarhus, 8200, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. Circadian Activity Rhythms change

    Time frame: Change from baseline to time 2 (an average of 1 month)

    Rest/wake activity recorded with wrist actigraphy

  5. Circadian Activity Rhythms change

    Time frame: Change from baseline to time 3 (an average of 6 months)

    Rest/wake activity recorded with wrist actigraphy

  6. 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

  7. Circadian skin temperature change

    Time frame: Change from baseline to time 2 (an average of 1 month)

    Distal skin temperature recorded with wrist actigraphy

  8. Circadian skin temperature change

    Time frame: Change from baseline to time 3 (an average of 6 months)

    Distal skin temperature recorded with wrist actigraphy

  9. 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

  10. 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

Secondary outcomes

  1. Cognitive functioning change

    Time frame: Change from baseline to time 3 (an average of 6 months)

    Standard neuropsychological test battery

  2. Cognitive functioning change

    Time frame: Change from baseline to time 4 (through study completion, an average of 1 year)

    Standard neuropsychological test battery

  3. Cancer-related fatigue change

    Time frame: Change from baseline to time 2 (an average of 1 month)

    FACIT fatigue

  4. Cancer-related fatigue change

    Time frame: Change from baseline to time 3 (an average of 6 months)

    FACIT fatigue

  5. Cancer-related fatigue change

    Time frame: Change from baseline to time 4 (through study completion, an average of 1 year)

    FACIT fatigue

  6. Sleep change

    Time frame: Change from baseline to time 2 (an average of 1 month)

    Objective sleep recorded with wrist actigraphy

  7. Sleep change

    Time frame: Change from baseline to time 3 (an average of 6 months)

    Objective sleep recorded with wrist actigraphy

  8. Sleep change

    Time frame: Change from baseline to time 4 (through study completion, an average of 1 year)

    Objective sleep recorded with wrist actigraphy

  9. 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.

  10. 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.

  11. Stress change

    Time frame: Change from baseline to time 2 (an average of 1 month)

    Perceived Stress Scale (PSS)

  12. Stress change

    Time frame: Change from baseline to time 3 (an average of 6 months)

    PSS

  13. Stress change

    Time frame: Change from baseline to time 4 (through study completion, an average of 1 year)

    PSS

  14. Sleep quality change

    Time frame: Change from baseline to time 2 (an average of 1 month)

    Pittsburgh sleep quality index

  15. Sleep quality change

    Time frame: Change from baseline to time 3 (an average of 6 months)

    Pittsburgh sleep quality index

  16. Sleep quality change

    Time frame: Change from baseline to time 4 (through study completion, an average of 1 year)

    Pittsburgh sleep quality index

  17. Insomnia change

    Time frame: Change from baseline to time 2 (an average of 1 month)

    Insomnia Severity Index

  18. Insomnia change

    Time frame: Change from baseline to time 3 (an average of 6 months)

    Insomnia Severity Index

  19. Insomnia change

    Time frame: Change from baseline to time 4 (through study completion, an average of 1 year)

    Insomnia Severity Index

  20. 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)

  21. Self-reported cognitive functioning change

    Time frame: Change from baseline to time 3 (an average of 6 months)

    FACT-Cog

  22. Self-reported cognitive functioning change

    Time frame: Change from baseline to time 4 (through study completion, an average of 1 year)

    FACT-Cog

  23. Depression change

    Time frame: Change from baseline to time 2 (an average of 1 month)

    Center for Epidemiologic Studies Depression Scale (CESD)

  24. Depression change

    Time frame: Change from baseline to time 3 (an average of 6 months)

    CESD

  25. Depression change

    Time frame: Change from baseline to time 4 (through study completion, an average of 1 year)

    CESD

  26. Self-reported quality of life change

    Time frame: Change from baseline to time 2 (an average of 1 month)

    Short Form 36 (SF36)

  27. Self-reported quality of life change

    Time frame: Change from baseline to time 3 (an average of 6 months)

    SF36

  28. Self-reported quality of life change

    Time frame: Change from baseline to time 4 (through study completion, an average of 1 year)

    SF36

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Collaborators

  • Danish Cancer Society
  • University of Aarhus

Registry information

Official study title

The Role of Circadian Rhythms in Cancer-Related Symptoms: A Prospective Controlled Chrono-Bio-Behavioral Observation Study

Acronym: CHRONO

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
May 26, 2020
Registry last updated
Jun 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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