CHRONO: The Role of Circadian Rhythms in Cancer-Related Symptoms

Sponsor

Aarhus University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04401189

Collaborator

University of Aarhus (Other), Danish Cancer Society (Other)

124

Enrollment

Location

Anticipated Duration (Months)

5.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Fatigue Cognitive Impairment Sleep Depression Quality of Life Stress, Psychological Inflammation Circadian Rhythm Disorders Cancer-Related Syndrome

Study Design

Study Type:

Observational

Anticipated Enrollment :

124 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jun 1, 2020

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Jun 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Breast cancer patients
Healthy controls

Outcome Measures

Primary Outcome Measures

Cancer related symptoms composite score change [Change from baseline to time 2 (an average of 1 month)]
A composite score will be calculated based on measures of fatigue, sleep, cognition, and depression as described under secondary outcomes
Cancer related symptoms composite score change [Change from baseline to time 3 (an average of 6 months)]
A composite score will be calculated based on measures of fatigue, sleep, cognition, and depression as described under secondary outcomes
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
Circadian Activity Rhythms change [Change from baseline to time 2 (an average of 1 month)]
Rest/wake activity recorded with wrist actigraphy
Circadian Activity Rhythms change [Change from baseline to time 3 (an average of 6 months)]
Rest/wake activity recorded with wrist actigraphy
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 2 (an average of 1 month)]
Distal skin temperature recorded with wrist actigraphy
Circadian skin temperature change [Change from baseline to time 3 (an average of 6 months)]
Distal skin temperature 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
Dim light melatonin onset change [Change from baseline to time 4 (through study completion, an average of 1 year)]
Melatonin based on saliva samples

Secondary Outcome Measures

Cognitive functioning change [Change from baseline to time 3 (an average of 6 months)]
Standard neuropsychological test battery
Cognitive functioning change [Change from baseline to time 4 (through study completion, an average of 1 year)]
Standard neuropsychological test battery
Cancer-related fatigue change [Change from baseline to time 2 (an average of 1 month)]
FACIT fatigue
Cancer-related fatigue change [Change from baseline to time 3 (an average of 6 months)]
FACIT fatigue
Cancer-related fatigue change [Change from baseline to time 4 (through study completion, an average of 1 year)]
FACIT fatigue
Sleep change [Change from baseline to time 2 (an average of 1 month)]
Objective sleep recorded with wrist actigraphy
Sleep change [Change from baseline to time 3 (an average of 6 months)]
Objective sleep recorded with wrist actigraphy
Sleep change [Change from baseline to time 4 (through study completion, an average of 1 year)]
Objective sleep recorded with wrist actigraphy
Inflammatory markers change [Change from baseline to time 3 (an average of 6 months)]
Proinflammatory cytokines known to mediate chronic inflammatory processes. Extracted from blood samples.
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.
Stress change [Change from baseline to time 2 (an average of 1 month)]
Perceived Stress Scale (PSS)
Stress change [Change from baseline to time 3 (an average of 6 months)]
PSS
Stress change [Change from baseline to time 4 (through study completion, an average of 1 year)]
PSS
Sleep quality change [Change from baseline to time 2 (an average of 1 month)]
Pittsburgh sleep quality index
Sleep quality change [Change from baseline to time 3 (an average of 6 months)]
Pittsburgh sleep quality index
Sleep quality change [Change from baseline to time 4 (through study completion, an average of 1 year)]
Pittsburgh sleep quality index
Insomnia change [Change from baseline to time 2 (an average of 1 month)]
Insomnia Severity Index
Insomnia change [Change from baseline to time 3 (an average of 6 months)]
Insomnia Severity Index
Insomnia change [Change from baseline to time 4 (through study completion, an average of 1 year)]
Insomnia Severity Index
Self-reported cognitive functioning change [Change from baseline to time 2 (an average of 1 month)]
Functional Assessment of Cancer Therapy - Cognitive function issues (FACT-Cog)
Self-reported cognitive functioning change [Change from baseline to time 3 (an average of 6 months)]
FACT-Cog
Self-reported cognitive functioning change [Change from baseline to time 4 (through study completion, an average of 1 year)]
FACT-Cog
Depression change [Change from baseline to time 2 (an average of 1 month)]
Center for Epidemiologic Studies Depression Scale (CESD)
Depression change [Change from baseline to time 3 (an average of 6 months)]
CESD
Depression change [Change from baseline to time 4 (through study completion, an average of 1 year)]
CESD
Self-reported quality of life change [Change from baseline to time 2 (an average of 1 month)]
Short Form 36 (SF36)
Self-reported quality of life change [Change from baseline to time 3 (an average of 6 months)]
SF36
Self-reported quality of life change [Change from baseline to time 4 (through study completion, an average of 1 year)]
SF36

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.