Clinical trial · Interventional
Reducing Cancer Side-effects With Systematic Light Exposure
- 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)
The main purpose of this interdisciplinary proposal is to conduct two randomized controlled trial (RCT) of the efficacy of self-administered systematic light exposure (Bright White Light (BWL)), an innovative, low cost, and low burden intervention to treat cancer-related fatigue. Another common and often overlapping treatment side-effect is cognitive impairment. A secondary outcome of the proposed RCT is, thus, cognitive functioning. Finally, possible underlying chronobiological (circadian activity rhythms, sleep), biological (pro inflammatory markers), and neurophysiological (brain morphology) mechanisms of BWL will be explored.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer-related Cognitive Impairment | — | UNRESOLVED | — |
| Cancer-related Fatigue | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Litebook | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Systematic bright light exposure
- description
- Systematic bright light exposure for 30 min. for 4 weeks
- interventionNames
- Device: Litebook
- type
- ACTIVE_COMPARATOR
- label
- Systematic dim light exposure
- description
- Systematic dim light exposure for 30 min. for 4 weeks
- interventionNames
- Device: Litebook
Primary outcomes (2)
- measure
- Cancer-related fatigue (FACIT-fatigue)
- timeFrame
- Changes in fatigue from baseline to immediately after intervention (T1-T2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria - Group 1: * High-risk breast cancer patients as defined by the Danish Breast Cancer Cooperative Group (DBCG) having received treatment according to the DBCG guidelines * Minimum age of 18 years; completion of adjuvant whole breast radiation treatments * A score \<34 on the FACIT-Fatigue scale (see below) after radiotherapy * Availability for home-based 4-week BWL/DL-treatment. Exclusion Criteria: * History of chronic fatigue disorders * Pregnancy * Confounding underlying medical illnesses such as significant pre-existing anemia * Diagnosed or suspected psychiatric or medical condition that might contribute to fatigue (other than those caused by the cancer or its treatment) * History of bipolar disease or mania (which are contra-indications for light treatment) * Current clinical depression * History of seasonal affective disorder * Previous diagnosis of sleep apnea, restless legs or other sleep disorders (not including insomnia) known to affect fatigue * Employment in shift work * Chronic use of oral steroid medication * Prior use of light treatment * Use of photosensitising medications * Plans to travel across meridians * Insufficient Danish language proficiency Inclusion criteria - Group 2: * Low-risk postmenopausal patients as defined by the DBCG having received breast-conserving surgery for lymph node-negative breast cancer * Completion of adjuvant whole breast radiation treatments * A score \<34 on the FACIT Fatigue scale (see below) after radiotherapy * Availability for home-based 4-week BWL/DL-treatment. Exclusion Criteria: * History of chronic fatigue disorders * Pregnancy * Confounding underlying medical illnesses such as significant pre-existing anemia * Diagnosed or suspected psychiatric or medical condition that might contribute to fatigue (other than those caused by the cancer or its treatment) * History of bipolar disease or mania (which are contra-indications for light treatment) * Current clinical depression * History of seasonal affective disorder * Previous diagnosis of sleep apnea, restless legs or other sleep disorders (not including insomnia) known to affect fatigue * Employment in shift work * Chronic use of oral steroid medication * Prior use of light treatment * Use of photosensitising medications * Plans to travel across meridians * Insufficient Danish language proficiency
References
Publications (0)
Data not yet available