The Role of Circadian Rhythms in Cancer-Related Symptoms

Completed

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

• Registration Number: NCT04401189
• Lead Sponsor: Aarhus University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-19
• Study First Submitted QC: 2020-05-20
• Study First Posted: 2020-05-26
• Study Start: 2020-06-01
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-27
• Last Update Posted: 2024-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 124

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cancer related symptoms composite score change	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
Dim light melatonin onset change	Change from baseline to time 4 (through study completion, an average of 1 year)	Melatonin based on saliva samples
Circadian Activity Rhythms change	Change from baseline to time 4 (through study completion, an average of 1 year)	Rest/wake activity recorded with wrist actigraphy
Circadian skin temperature change	Change from baseline to time 4 (through study completion, an average of 1 year)	Distal skin temperature recorded with wrist actigraphy

Secondary Outcome Measures

Name	Time	Method
Sleep quality change	Change from baseline to time 4 (through study completion, an average of 1 year)	Pittsburgh sleep quality index
Inflammatory markers change	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.
Insomnia change	Change from baseline to time 4 (through study completion, an average of 1 year)	Insomnia Severity Index
Cognitive functioning change	Change from baseline to time 4 (through study completion, an average of 1 year)	Standard neuropsychological test battery
Depression change	Change from baseline to time 4 (through study completion, an average of 1 year)	CESD
Cancer-related fatigue change	Change from baseline to time 4 (through study completion, an average of 1 year)	FACIT fatigue
Stress change	Change from baseline to time 4 (through study completion, an average of 1 year)	PSS
Self-reported quality of life change	Change from baseline to time 4 (through study completion, an average of 1 year)	SF36
Sleep change	Change from baseline to time 4 (through study completion, an average of 1 year)	Objective sleep recorded with wrist actigraphy
Self-reported cognitive functioning change	Change from baseline to time 4 (through study completion, an average of 1 year)	FACT-Cog

Trial Locations

Locations (1)

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark