The Role of Circadian Rhythms in Cancer-Related Symptoms

Breast Cancer Clinical Trial

— CHRONO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04401189
• Other study ID #: 2016-051-000001- 1731
• Status: Recruiting
• Start date: June 1, 2020
• Est. completion date: June 2022

Study information

• Verified date: April 2021
• Source: Aarhus University Hospital
• Contact: Ali Amidi, PhD
• Phone: (+45) 8716 5305
• Email: ali[@]psy.au.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 124
• Est. completion date: June 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus

Sponsors (3)

Lead Sponsor	Collaborator
Aarhus University Hospital	Danish Cancer Society, University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	Circadian Activity Rhythms change	Rest/wake activity recorded with wrist actigraphy	Change from baseline to time 2 (an average of 1 month)
Primary	Circadian Activity Rhythms change	Rest/wake activity recorded with wrist actigraphy	Change from baseline to time 3 (an average of 6 months)
Primary	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)
Primary	Circadian skin temperature change	Distal skin temperature recorded with wrist actigraphy	Change from baseline to time 2 (an average of 1 month)
Primary	Circadian skin temperature change	Distal skin temperature recorded with wrist actigraphy	Change from baseline to time 3 (an average of 6 months)
Primary	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)
Primary	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	Cognitive functioning change	Standard neuropsychological test battery	Change from baseline to time 3 (an average of 6 months)
Secondary	Cognitive functioning change	Standard neuropsychological test battery	Change from baseline to time 4 (through study completion, an average of 1 year)
Secondary	Cancer-related fatigue change	FACIT fatigue	Change from baseline to time 2 (an average of 1 month)
Secondary	Cancer-related fatigue change	FACIT fatigue	Change from baseline to time 3 (an average of 6 months)
Secondary	Cancer-related fatigue change	FACIT fatigue	Change from baseline to time 4 (through study completion, an average of 1 year)
Secondary	Sleep change	Objective sleep recorded with wrist actigraphy	Change from baseline to time 2 (an average of 1 month)
Secondary	Sleep change	Objective sleep recorded with wrist actigraphy	Change from baseline to time 3 (an average of 6 months)
Secondary	Sleep change	Objective sleep recorded with wrist actigraphy	Change from baseline to time 4 (through study completion, an average of 1 year)
Secondary	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)
Secondary	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)
Secondary	Stress change	Perceived Stress Scale (PSS)	Change from baseline to time 2 (an average of 1 month)
Secondary	Stress change	PSS	Change from baseline to time 3 (an average of 6 months)
Secondary	Stress change	PSS	Change from baseline to time 4 (through study completion, an average of 1 year)
Secondary	Sleep quality change	Pittsburgh sleep quality index	Change from baseline to time 2 (an average of 1 month)
Secondary	Sleep quality change	Pittsburgh sleep quality index	Change from baseline to time 3 (an average of 6 months)
Secondary	Sleep quality change	Pittsburgh sleep quality index	Change from baseline to time 4 (through study completion, an average of 1 year)
Secondary	Insomnia change	Insomnia Severity Index	Change from baseline to time 2 (an average of 1 month)
Secondary	Insomnia change	Insomnia Severity Index	Change from baseline to time 3 (an average of 6 months)
Secondary	Insomnia change	Insomnia Severity Index	Change from baseline to time 4 (through study completion, an average of 1 year)
Secondary	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)
Secondary	Self-reported cognitive functioning change	FACT-Cog	Change from baseline to time 3 (an average of 6 months)
Secondary	Self-reported cognitive functioning change	FACT-Cog	Change from baseline to time 4 (through study completion, an average of 1 year)
Secondary	Depression change	Center for Epidemiologic Studies Depression Scale (CESD)	Change from baseline to time 2 (an average of 1 month)
Secondary	Depression change	CESD	Change from baseline to time 3 (an average of 6 months)
Secondary	Depression change	CESD	Change from baseline to time 4 (through study completion, an average of 1 year)
Secondary	Self-reported quality of life change	Short Form 36 (SF36)	Change from baseline to time 2 (an average of 1 month)
Secondary	Self-reported quality of life change	SF36	Change from baseline to time 3 (an average of 6 months)
Secondary	Self-reported quality of life change	SF36	Change from baseline to time 4 (through study completion, an average of 1 year)