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Clinical Trials in Denmark / NCT06845267
Starting soon Not applicable

Chrono-behavioral Therapy for Chronic Fatigue in Cancer

NCT06845267 · tracked via the Priya Life Science Denmark tracker
Sponsor
Aarhus University Hospital
Phase
Not applicable
Started
2025-04-01
Last updated
2025-03-14

Condition(s) studied

Chronic FatigueCancer Survivors

Investigational drug(s) / intervention(s)

ChronotherapyControl

Chronotherapy: This study utilize and test different combinations of three types of interventions (zeitgebers) to entrain the circadian rhythm: 1) Light being the primary photic zeitgebers that directly entrain the SCN, 2) physical activity and 3) timing of eating) being non-photic zeitgebers that drive peripheral rhythms.

Control: Control condition

Study summary

Cancer-related fatigue (CRF) is a severe and persistent side effect of cancer and its treatment, affecting up to 40% of patients and significantly reducing quality of life. Recent research suggests that circadian rhythm disruption has been implicated as a possible related pathophysiological mechanism underlying CRF. Circadian rhythms are 24-hour cycles regulating physiology and behavior through environmental cues called "zeitgebers." Strengthening these cues-such as light exposure, physical activity, and eating-may help reduce CRF.

This project will develop and test the optimal combination a home-based, low-burden chrono-behavioral therapy (ChronoBT) targeting these zeitgebers.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. prostate or female breast cancer survivors 2. completed local and/or adjuvant cancer therapy (with the exception of hormonal therapy) ≥ 1 year previously 3. ≥18 years of age 4. able to speak and read Danish 5. experiencing CRF (score ≤36 on FACT-F) Exclusion Criteria: 1. use of light therapy in the last year 2. confounding underlying medical/psychiatric disorders or use of medications associated with fatigue (e.g., a central nervous system cancer, untreated hypothyroidism, anemia, chronic fatigue syndrome, insomnia, major depression) 3. non-cancer related factor likely to be a driver of fatigue (e.g., shift work, pregnancy, recent travel across time zones) 4. recurrence of cancer or new cancer 5. physical or psychological conditions that could prevent participation in intervention components 6. use of photosensitizing medications

Primary outcome measure(s)

  • Cancer-related Fatigue — T1 (Baseline, pre-intervention), T2 (two weeks post intervention initiation), T3 (1 day post intervention completion), T4 (follow-up 4 weeks post intervention completion)
    Cancer-related Fatigue by the Functional Assessment of Cancer Therapy - Fatigue Scale (FACT-F) Number of items: 13. Score range: 0-52. Lower score indicates more fatigue.

Trial sites (1)

FacilityCityRegionStatus
Aarhus University and Aarhus University Hospital Aarhus Denmark

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06845267 on ClinicalTrials.gov ↗ ← All trials in Denmark