Clinical trial · Observational
The Role of Circadian Rhythms in Cancer-Related Symptoms
The Role of Circadian Rhythms in Cancer-Related Symptoms: A Prospective Controlled Chrono-Bio-Behavioral Observation Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (10)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cancer-Related Syndrome | — | UNRESOLVED | — |
| Circadian Rhythm Disorders | — | UNRESOLVED | — |
| Cognitive Impairment | — | UNRESOLVED | — |
| Depression | — | UNRESOLVED | — |
| Fatigue | — | UNRESOLVED | — |
| Inflammation | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
| Sleep | — | UNRESOLVED | — |
| Stress, Psychological |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Breast cancer patients
- label
- Healthy controls
Primary outcomes (10)
- measure
- Cancer related symptoms composite score change
- timeFrame
- Change from baseline to time 2 (an average of 1 month)
- description
- A composite score will be calculated based on measures of fatigue, sleep, cognition, and depression as described under secondary outcomes
- measure
- Cancer related symptoms composite score change
- timeFrame
- Change from baseline to time 3 (an average of 6 months)
- description
- A composite score will be calculated based on measures of fatigue, sleep, cognition, and depression as described under secondary outcomes
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available