- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02661308
Reducing Cancer Side-effects With Systematic Light Exposure (LYS)
Study Overview
Status
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ali Amidi, Ph.D.
- Phone Number: +4587165305
- Email: ali@psy.au.dk
Study Locations
-
-
-
Aarhus, Denmark, 8000
- Recruiting
- Aarhus Universitets Hospital
-
Contact:
- Birgitte Offersen, PhD, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Systematic bright light exposure
Systematic bright light exposure for 30 min.
for 4 weeks
|
|
Active Comparator: Systematic dim light exposure
Systematic dim light exposure for 30 min.
for 4 weeks
|
What is the study measuring?
Primary Outcome Measures
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
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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