NCT06845267

Chrono-behavioral Therapy for Chronic Fatigue in Cancer

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Aarhus University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Cancer-related fatigue (CRF) is frequently reported as the most severe and distressing side effect of cancer and its treatment. Among cancer patients, up to 40% will experience CRF that can last months or even years after treatment and it is also deleterious to quality of life. However, there is still no established CRF treatment. Underlying mechanisms of CRF are likely multi-factorial and recently, circadian rhythm disruption has been implicated as a possible related pathophysiological mechanism underlying CRF. Circadian rhythms are endogenous 24-hour cycles of rhythmicity in physiology and behavior orchestrated by the suprachiasmatic nuclei (SCN) in the brain. They are entrained to the environment via time-giving cues called "zeitgebers". Thus, improving circadian rhythm robustness by strengthening modifiable zeitgebers is one potential way to ameliorate CRF. The overarching goal of the proposed project is to conduct an optimization trial of a home-based, low-burden multicomponent chrono-behavioral therapy (ChronoBT) that aims to strengthen the effects of 3 zeitgebers to treat CRF - light/dark exposure, physical activity and eating - all of which individually have shown promise in strengthening circadian rhythms and reducing fatigue. The study will include two work packages: In Work Package 1 (WP1), the investigators will pilot test candidate intervention components in prostate and female breast cancer survivors. In Work Package 2 (WP2), a fully powered optimization trial will be undertaken using the framework - the Multiphase Optimization Strategy (MOST), to test the optimal combination of ChronoBT components.

Conditions

• Chronic Fatigue
• Cancer Survivors

Interventions

Type	Name	Description
BEHAVIORAL	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.
BEHAVIORAL	Control	Control condition

Timeline

• Start date: 2025-04-01
• Primary completion: 2027-07-01
• Completion: 2027-11-01
• First posted: 2025-02-25
• Last updated: 2025-03-14

Locations

1 site across 1 country: Denmark