The Role of Circadian Rhythms in Cancer-Related Symptoms

Study Overview
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Brief Summary
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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.

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

Conditions
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Breast Cancer, Fatigue, Cognitive Impairment, Sleep, Depression, Quality of Life, Stress, Psychological, Inflammation, Circadian Rhythm Disorders, Cancer-Related Syndrome

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Breast cancer patients<br> | |
| Healthy controls<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive functioning change | Standard neuropsychological test battery | Change from baseline to time 3 (an average of 6 months) | 
| Cognitive functioning change | Standard neuropsychological test battery | Change from baseline to time 4 (through study completion, an average of 1 year) | 
| Cancer-related fatigue change | FACIT fatigue | Change from baseline to time 2 (an average of 1 month) | 
| Cancer-related fatigue change | FACIT fatigue | Change from baseline to time 3 (an average of 6 months) | 
| Cancer-related fatigue change | FACIT fatigue | Change from baseline to time 4 (through study completion, an average of 1 year) | 
| Sleep change | Objective sleep recorded with wrist actigraphy | Change from baseline to time 2 (an average of 1 month) | 
| Sleep change | Objective sleep recorded with wrist actigraphy | Change from baseline to time 3 (an average of 6 months) | 
| Sleep change | Objective sleep recorded with wrist actigraphy | Change from baseline to time 4 (through study completion, an average of 1 year) | 
| Inflammatory markers change | 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 | 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 | Perceived Stress Scale (PSS) | Change from baseline to time 2 (an average of 1 month) | 
| Stress change | PSS | Change from baseline to time 3 (an average of 6 months) | 
| Stress change | PSS | Change from baseline to time 4 (through study completion, an average of 1 year) | 
| Sleep quality change | Pittsburgh sleep quality index | Change from baseline to time 2 (an average of 1 month) | 
| Sleep quality change | Pittsburgh sleep quality index | Change from baseline to time 3 (an average of 6 months) | 
| Sleep quality change | Pittsburgh sleep quality index | Change from baseline to time 4 (through study completion, an average of 1 year) | 
| Insomnia change | Insomnia Severity Index | Change from baseline to time 2 (an average of 1 month) | 
| Insomnia change | Insomnia Severity Index | Change from baseline to time 3 (an average of 6 months) | 
| Insomnia change | Insomnia Severity Index | Change from baseline to time 4 (through study completion, an average of 1 year) | 
| Self-reported cognitive functioning change | 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 | FACT-Cog | Change from baseline to time 3 (an average of 6 months) | 
| Self-reported cognitive functioning change | FACT-Cog | Change from baseline to time 4 (through study completion, an average of 1 year) | 
| Depression change | Center for Epidemiologic Studies Depression Scale (CESD) | Change from baseline to time 2 (an average of 1 month) | 
| Depression change | CESD | Change from baseline to time 3 (an average of 6 months) | 
| Depression change | CESD | Change from baseline to time 4 (through study completion, an average of 1 year) | 
| Self-reported quality of life change | Short Form 36 (SF36) | Change from baseline to time 2 (an average of 1 month) | 
| Self-reported quality of life change | SF36 | Change from baseline to time 3 (an average of 6 months) | 
| Self-reported quality of life change | SF36 | Change from baseline to time 4 (through study completion, an average of 1 year) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer, Circadian rhythms disruption, Cancer-related symptoms