Clinical trial NCT04401189: The Role of Circadian Rhythms in Cancer-Related Symptoms
Official title: The Role of Circadian Rhythms in Cancer-Related Symptoms: A Prospective Controlled Chrono-Bio-Behavioral Observation Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Fatigue
Cognitive Impairment
Sleep
Depression
Quality of Life
Stress, Psychological
Inflammation
Circadian Rhythm Disorders
Cancer-Related Syndrome
Keywords: Breast cancer
Circadian rhythms disruption
Cancer-related symptoms
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
Collaborators: name: University of Aarhus
name: Danish Cancer Society
First posted: 2020-05-26
Enrollment: 124
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newly diagnosed breast cancer patients. Controls will be healthy volunteers of cancer-free women matched on age.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Cancer related symptoms composite score change
timeFrame: Change from baseline to time 2 (an average of 1 month)
measure: Cancer related symptoms composite score change
timeFrame: Change from baseline to time 3 (an average of 6 months)
measure: Cancer related symptoms composite score change
timeFrame: Change from baseline to time 4 (through study completion, an average of 1 year)
measure: Circadian Activity Rhythms change
timeFrame: Change from baseline to time 2 (an average of 1 month)
measure: Circadian Activity Rhythms change
timeFrame: Change from baseline to time 3 (an average of 6 months)
measure: Circadian Activity Rhythms change
timeFrame: Change from baseline to time 4 (through study completion, an average of 1 year)
measure: Circadian skin temperature change
timeFrame: Change from baseline to time 2 (an average of 1 month)
measure: Circadian skin temperature change
timeFrame: Change from baseline to time 3 (an average of 6 months)
measure: Circadian skin temperature change
timeFrame: Change from baseline to time 4 (through study completion, an average of 1 year)
measure: Dim light melatonin onset change
timeFrame: Change from baseline to time 4 (through study completion, an average of 1 year)
Secondary outcomes:
measure: Cognitive functioning change
timeFrame: Change from baseline to time 3 (an average of 6 months)
measure: Cognitive functioning change
timeFrame: Change from baseline to time 4 (through study completion, an average of 1 year)
measure: Cancer-related fatigue change
timeFrame: Change from baseline to time 2 (an average of 1 month)
measure: Cancer-related fatigue change
timeFrame: Change from baseline to time 3 (an average of 6 months)
measure: Cancer-related fatigue change
timeFrame: Change from baseline to time 4 (through study completion, an average of 1 year)
measure: Sleep change
timeFrame: Change from baseline to time 2 (an average of 1 month)
measure: Sleep change
timeFrame: Change from baseline to time 3 (an average of 6 months)
measure: Sleep change
timeFrame: Change from baseline to time 4 (through study completion, an average of 1 year)
measure: Inflammatory markers change
timeFrame: Change from baseline to time 3 (an average of 6 months)
measure: Inflammatory markers change
timeFrame: Change from baseline to time 4 (through study completion, an average of 1 year)
measure: Stress change
timeFrame: Change from baseline to time 2 (an average of 1 month)
measure: Stress change
timeFrame: Change from baseline to time 3 (an average of 6 months)
measure: Stress change
timeFrame: Change from baseline to time 4 (through study completion, an average of 1 year)
measure: Sleep quality change
timeFrame: Change from baseline to time 2 (an average of 1 month)
measure: Sleep quality change
timeFrame: Change from baseline to time 3 (an average of 6 months)
measure: Sleep quality change
timeFrame: Change from baseline to time 4 (through study completion, an average of 1 year)
measure: Insomnia change
timeFrame: Change from baseline to time 2 (an average of 1 month)
measure: Insomnia change
timeFrame: Change from baseline to time 3 (an average of 6 months)
measure: Insomnia change
timeFrame: Change from baseline to time 4 (through study completion, an average of 1 year)
measure: Self-reported cognitive functioning change
timeFrame: Change from baseline to time 2 (an average of 1 month)
measure: Self-reported cognitive functioning change
timeFrame: Change from baseline to time 3 (an average of 6 months)
measure: Self-reported cognitive functioning change
timeFrame: Change from baseline to time 4 (through study completion, an average of 1 year)
measure: Depression change
timeFrame: Change from baseline to time 2 (an average of 1 month)
measure: Depression change
timeFrame: Change from baseline to time 3 (an average of 6 months)
measure: Depression change
timeFrame: Change from baseline to time 4 (through study completion, an average of 1 year)
measure: Self-reported quality of life change
timeFrame: Change from baseline to time 2 (an average of 1 month)
measure: Self-reported quality of life change
timeFrame: Change from baseline to time 3 (an average of 6 months)
measure: Self-reported quality of life change
timeFrame: Change from baseline to time 4 (through study completion, an average of 1 year)
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
References: