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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04401189
Other study ID # 2016-051-000001- 1731
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


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)
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