Cancer-related FatigueLYSNCT02661308
Reducing Cancer Side-effects With Systematic Light Exposure
A study testing Litebook in people with Cancer-related Fatigue and Cancer-related Cognitive Impairment, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cancer-related Fatigue, Cancer-related Cognitive Impairment
- What is being tested?
- Litebook
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2016to 1 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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.
Who cannot join
- 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
Show all 28Show fewer
- 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
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Two independent but similar RCTs with a total of 144 breast cancer patients (Group 1 = 72 high risk patients; Group 2 = 72 low risk breast cancer patients) post-treatment screened for fatigue will be randomized to BWL (36 in each of the two groups) or dim light(DL) (36 in each of the two groups) exposure for 30 minutes/morning for 4 weeks, and assessed before, during, immediately and 3 months after the intervention. Measures include questionnaires, cognitive assessment, actigraphy, blood samples, saliva samples, and magnetic resonance imaging (MRI).
1.1 Aims and hypotheses. Aim 1: To test the efficacy of BWL on fatigue (primary outcome) in breast cancer patients.
Hypothesis 1: Compared with control participants exposed to DL, participants randomized to BWL will report less fatigue immediately and 3 months after the intervention.
Aim 2: To test the efficacy of BWL on cognitive functioning (secondary outcome).
Hypothesis 2: Compared with controls, BWL recipients will show improved cognitive functioning immediately and 3 months after the intervention.
Aim 3: To explore the effects of BWL on chronobiological, biological, and neurophysiological markers.
Hypothesis 3: BWL will be associated with normalized circadian activity rhythms (3a); improved sleep (3b); decreased inflammation (3c); increased cortical and subcortical grey matter density (3d); and increased cortical and subcortical white matter integrity (3e). If hypotheses 1 and/or 2 are confirmed, the mediating effects of the markers will be explored.
- Being tested
- Litebook
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LitebookDevice
| Study group | Role | What they receive |
|---|---|---|
| Systematic bright light exposure | Experimental | Systematic bright light exposure for 30 min. for 4 weeks Receives: Device: Litebook |
| Systematic dim light exposure | Active comparator | Systematic dim light exposure for 30 min. for 4 weeks Receives: Device: Litebook |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cancer-related fatigue (FACIT-fatigue)
Measured: Changes in fatigue from baseline to immediately after intervention (T1-T2)
Cancer-related fatigue (FACIT-fatigue)
Measured: Changes in fatigue from baseline to 3 months after intervention
Secondary outcomes (10)
Pittsburgh Sleep Quality Index (PSQI)
Measured: Immediately after intervention and 3 months after intervention
Beck's Depression Inventory - II (BDI-II)
Measured: Immediately after intervention and 3 months after intervention
Connors Continous performance test (CPT-3)
Measured: Immediately after intervention
Psychomotor vigilance test (PVT)
Measured: Immediately after intervention
Hopkins Verbal Learning Test (HVLT-R)
Measured: Immediately after intervention
Health-related quality of life (SF-36)
Measured: Immediately after intervention and 3 months after intervention
Anxiety symptoms (HADS Anxiety)
Measured: Immediately after intervention and 3 months after intervention
Impact of events (IES-R)
Measured: Immediately after intervention and 3 months after intervention
Patients assessment of own functioning Inventory (POAFI)
Measured: Immediately after intervention and 3 months after intervention
Overall neuropsychological composite score
Measured: Immediately after intervention and 3 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2016 (estimated)
- Study startMar 2016
- Primary completion1 Jan 2022
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer-related FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Amidi, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02661308
- Sponsor's protocol ID
- Sagsnr. 1-10-72-286-15
- Acronym
- LYS
- Status last verified
- Jun 2024
- First submitted
- 15 Dec 2015
- Last updated
- 28 Jun 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Cancer Side-effects With Systematic Light Exposure
- ClinicalTrials.gov ID
- NCT02661308
- Acronym / sponsor ID
- LYS / Sagsnr. 1-10-72-286-15
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 22 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Two independent but similar RCTs with a total of 144 breast cancer patients (Group 1 = 72 high risk patients; Group 2 = 72 low risk breast cancer patients) post-treatment screened for fatigue will be randomized to BWL (36 in each of the two groups) or dim light(DL) (36 in each of the two groups) exposure for 30 minutes/morning for 4 weeks, and assessed before, during, immediately and 3 months after the intervention. Measures include questionnaires, cognitive assessment, actigraphy, blood samples, saliva samples, and magnetic resonance imaging (MRI).
1.1 Aims and hypotheses. Aim 1: To test the efficacy of BWL on fatigue (primary outcome) in breast cancer patients.
Hypothesis 1: Compared with control participants exposed to DL, participants randomized to BWL will report less fatigue immediately and 3 months after the intervention.
Aim 2: To test the efficacy of BWL on cognitive functioning (secondary outcome).
Hypothesis 2: Compared with controls, BWL recipients will show improved cognitive functioning immediately and 3 months after the intervention.
Aim 3: To explore the effects of BWL on chronobiological, biological, and neurophysiological markers.
Hypothesis 3: BWL will be associated with normalized circadian activity rhythms (3a); improved sleep (3b); decreased inflammation (3c); increased cortical and subcortical grey matter density (3d); and increased cortical and subcortical white matter integrity (3e). If hypotheses 1 and/or 2 are confirmed, the mediating effects of the markers will be explored.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Systematic bright light exposure | Experimental | Device: LitebookSystematic bright light exposure for 30 min. for 4 weeks |
| Systematic dim light exposure | Active comparator | Device: LitebookSystematic dim light exposure for 30 min. for 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
- Low-risk postmenopausal patients as defined by the DBCG having received breast-conserving surgery for lymph node-negative breast cancer
Key exclusion criteria (28 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Litebook | Device | Systematic bright light exposure, Systematic dim light exposure |
Primary outcome
Cancer-related fatigue (FACIT-fatigue)
Time frame: Changes in fatigue from baseline to immediately after intervention (T1-T2)
Cancer-related fatigue (FACIT-fatigue)
Time frame: Changes in fatigue from baseline to 3 months after intervention
10 secondary outcomes
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Immediately after intervention and 3 months after intervention
Beck's Depression Inventory - II (BDI-II)
Time frame: Immediately after intervention and 3 months after intervention
Connors Continous performance test (CPT-3)
Time frame: Immediately after intervention
Psychomotor vigilance test (PVT)
Time frame: Immediately after intervention
Hopkins Verbal Learning Test (HVLT-R)
Time frame: Immediately after intervention
Health-related quality of life (SF-36)
Time frame: Immediately after intervention and 3 months after intervention
Anxiety symptoms (HADS Anxiety)
Time frame: Immediately after intervention and 3 months after intervention
Impact of events (IES-R)
Time frame: Immediately after intervention and 3 months after intervention
Patients assessment of own functioning Inventory (POAFI)
Time frame: Immediately after intervention and 3 months after intervention
Overall neuropsychological composite score
Time frame: Immediately after intervention and 3 months after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Litebook in people with Cancer-related Fatigue and Cancer-related Cognitive Impairment, run by Aarhus University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cancer-related fatigue (FACIT-fatigue) (time frame: Changes in fatigue from baseline to immediately after intervention (T1-T2)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2024.