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

Primary Purpose

Cancer-related Fatigue, Cancer-related Cognitive Impairment

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Litebook
Sponsored by
Aarhus University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer-related Fatigue

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Aarhus Universitets HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Systematic bright light exposure

Systematic dim light exposure

Arm Description

Systematic bright light exposure for 30 min. for 4 weeks

Systematic dim light exposure for 30 min. for 4 weeks

Outcomes

Primary Outcome Measures

Cancer-related fatigue (FACIT-fatigue)
Cancer-related fatigue (FACIT-fatigue)

Secondary Outcome Measures

Pittsburgh Sleep Quality Index (PSQI)
Beck's Depression Inventory - II (BDI-II)
Connors Continous performance test (CPT-3)
Psychomotor vigilance test (PVT)
Hopkins Verbal Learning Test (HVLT-R)
Health-related quality of life (SF-36)
Anxiety symptoms (HADS Anxiety)
Impact of events (IES-R)
Patients assessment of own functioning Inventory (POAFI)
Overall neuropsychological composite score

Full Information

First Posted
December 15, 2015
Last Updated
February 9, 2021
Sponsor
Aarhus University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02661308
Brief Title
Reducing Cancer Side-effects With Systematic Light Exposure
Acronym
LYS
Official Title
Reducing Cancer Side-effects With Systematic Light Exposure
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (Actual)
Primary Completion Date
August 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aarhus University Hospital

4. Oversight

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer-related Fatigue, Cancer-related Cognitive Impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Systematic bright light exposure
Arm Type
Experimental
Arm Description
Systematic bright light exposure for 30 min. for 4 weeks
Arm Title
Systematic dim light exposure
Arm Type
Active Comparator
Arm Description
Systematic dim light exposure for 30 min. for 4 weeks
Intervention Type
Device
Intervention Name(s)
Litebook
Primary Outcome Measure Information:
Title
Cancer-related fatigue (FACIT-fatigue)
Time Frame
Changes in fatigue from baseline to immediately after intervention (T1-T2)
Title
Cancer-related fatigue (FACIT-fatigue)
Time Frame
Changes in fatigue from baseline to 3 months after intervention
Secondary Outcome Measure Information:
Title
Pittsburgh Sleep Quality Index (PSQI)
Time Frame
Immediately after intervention and 3 months after intervention
Title
Beck's Depression Inventory - II (BDI-II)
Time Frame
Immediately after intervention and 3 months after intervention
Title
Connors Continous performance test (CPT-3)
Time Frame
Immediately after intervention
Title
Psychomotor vigilance test (PVT)
Time Frame
Immediately after intervention
Title
Hopkins Verbal Learning Test (HVLT-R)
Time Frame
Immediately after intervention
Title
Health-related quality of life (SF-36)
Time Frame
Immediately after intervention and 3 months after intervention
Title
Anxiety symptoms (HADS Anxiety)
Time Frame
Immediately after intervention and 3 months after intervention
Title
Impact of events (IES-R)
Time Frame
Immediately after intervention and 3 months after intervention
Title
Patients assessment of own functioning Inventory (POAFI)
Time Frame
Immediately after intervention and 3 months after intervention
Title
Overall neuropsychological composite score
Time Frame
Immediately after intervention and 3 months after intervention
Other Pre-specified Outcome Measures:
Title
Mediators: Changes in brain white mater diffusion integrity as measured with diffusion-weighted MR imaging: Diffusion/kurtosis parameters.
Time Frame
Immediately after intervention
Title
Mediators: Changes in Pro-inflammatory cytokines (Il-1, Il-6, Tnf-alpha) (blood draw)
Time Frame
Changes from baseline to immediately after intervention
Title
Mediators: Changes in circadian activity rhythms (actigraphy)
Time Frame
Changes from baseline to immediately after intervention
Title
Mediators: Changes in diurnal Cortisol (saliva samples)
Time Frame
From baseline to immediately after intervention
Title
Mediators: Changes in diurnal melatonin (as measured with saliva samples)
Time Frame
From baseline to immediately after intervention
Title
Mediators: Changes in grey matter density as measured by T-1 weighted MR imaging (voxel-based morphometry)
Time Frame
Immediately after intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ali Amidi, Ph.D.
Phone
+4587165305
Email
ali@psy.au.dk
Facility Information:
Facility Name
Aarhus Universitets Hospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Birgitte Offersen, PhD, MD

12. IPD Sharing Statement

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Reducing Cancer Side-effects With Systematic Light Exposure

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