Reducing Cancer Side-effects With Systematic Light Exposure (LYS)

June 27, 2024 updated by: Ali Amidi, Aarhus University Hospital
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
108

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Ali Amidi, Ph.D.
  • Phone Number: +4587165305
  • Email: ali@psy.au.dk

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Aarhus Universitets Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Systematic bright light exposure
Systematic bright light exposure for 30 min. for 4 weeks
Device: Litebook
Active Comparator: Systematic dim light exposure
Systematic dim light exposure for 30 min. for 4 weeks
Device: Litebook

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Cancer-related fatigue (FACIT-fatigue)
Time Frame: Changes in fatigue from baseline to immediately after intervention (T1-T2)
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
Changes in fatigue from baseline to 3 months after intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Immediately after intervention and 3 months after intervention
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
Immediately after intervention and 3 months after intervention
Connors Continous performance test (CPT-3)
Time Frame: Immediately after intervention
Immediately after intervention
Psychomotor vigilance test (PVT)
Time Frame: Immediately after intervention
Immediately after intervention
Hopkins Verbal Learning Test (HVLT-R)
Time Frame: Immediately after intervention
Immediately after intervention
Health-related quality of life (SF-36)
Time Frame: Immediately after intervention and 3 months after intervention
Immediately after intervention and 3 months after intervention
Anxiety symptoms (HADS Anxiety)
Time Frame: Immediately after intervention and 3 months after intervention
Immediately after intervention and 3 months after intervention
Impact of events (IES-R)
Time Frame: Immediately after intervention and 3 months after intervention
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
Immediately after intervention and 3 months after intervention
Overall neuropsychological composite score
Time Frame: Immediately after intervention and 3 months after intervention
Immediately after intervention and 3 months after intervention

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Mediators: Changes in brain white mater diffusion integrity as measured with diffusion-weighted MR imaging: Diffusion/kurtosis parameters.
Time Frame: Immediately after intervention
Immediately after intervention
Mediators: Changes in Pro-inflammatory cytokines (Il-1, Il-6, Tnf-alpha) (blood draw)
Time Frame: Changes from baseline to immediately after intervention
Changes from baseline to immediately after intervention
Mediators: Changes in circadian activity rhythms (actigraphy)
Time Frame: Changes from baseline to immediately after intervention
Changes from baseline to immediately after intervention
Mediators: Changes in diurnal Cortisol (saliva samples)
Time Frame: From baseline to immediately after intervention
From baseline to immediately after intervention
Mediators: Changes in diurnal melatonin (as measured with saliva samples)
Time Frame: From baseline to immediately after intervention
From baseline to immediately after intervention
Mediators: Changes in grey matter density as measured by T-1 weighted MR imaging (voxel-based morphometry)
Time Frame: Immediately after intervention
Immediately after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aarhus University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 15, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 22, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 28, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Sagsnr. 1-10-72-286-15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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