Breast Cancer Clinical Trial
— CHRONOOfficial title:
The Role of Circadian Rhythms in Cancer-Related Symptoms: A Prospective Controlled Chrono-Bio-Behavioral Observation Study
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.
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. |
Country | Name | City | State |
---|---|---|---|
Denmark | Aarhus University Hospital | Aarhus |
Lead Sponsor | Collaborator |
---|---|
Aarhus University Hospital | Danish Cancer Society, University of Aarhus |
Denmark,
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) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04681911 -
Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer
|
Phase 2 | |
Completed |
NCT04890327 -
Web-based Family History Tool
|
N/A | |
Terminated |
NCT04066790 -
Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
|
Phase 2 | |
Completed |
NCT03591848 -
Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility
|
N/A | |
Recruiting |
NCT03954197 -
Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients
|
N/A | |
Terminated |
NCT02202746 -
A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer
|
Phase 2 | |
Active, not recruiting |
NCT01472094 -
The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
|
||
Withdrawn |
NCT06057636 -
Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study
|
N/A | |
Completed |
NCT06049446 -
Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
|
||
Recruiting |
NCT05560334 -
A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations
|
Phase 2 | |
Active, not recruiting |
NCT05501769 -
ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer
|
Phase 1 | |
Recruiting |
NCT04631835 -
Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer
|
Phase 1 | |
Completed |
NCT04307407 -
Exercise in Breast Cancer Survivors
|
N/A | |
Recruiting |
NCT03544762 -
Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation
|
Phase 3 | |
Terminated |
NCT02482389 -
Study of Preoperative Boost Radiotherapy
|
N/A | |
Enrolling by invitation |
NCT00068003 -
Harvesting Cells for Experimental Cancer Treatments
|
||
Completed |
NCT00226967 -
Stress, Diurnal Cortisol, and Breast Cancer Survival
|
||
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT06019325 -
Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy
|
N/A |