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

Aarhus University Hospital

Status: Completed

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

Study type: Observational

Funder types: Other

Identifiers

NCT04401189

2016-051-000001- 1731

Details and patient eligibility

About

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.

Enrollment: 124 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

124 participants in 2 patient groups

Breast cancer patients

Healthy controls