The Role of Circadian Rhythms in Cancer-Related Symptoms

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

124 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-01

Study Completion Date

2023-06-30

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.

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Detailed Description

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Conditions

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

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Breast cancer patients

No interventions assigned to this group

Healthy controls

No interventions assigned to this group

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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes