NCT02661308

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 15, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 22, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

June 28, 2024

Status Verified

June 1, 2024

Enrollment Period

5.8 years

First QC Date

December 15, 2015

Last Update Submit

June 27, 2024

Conditions

Cancer-related FatigueCancer-related Cognitive Impairment

Outcome Measures

Primary Outcomes (2)

  • Cancer-related fatigue (FACIT-fatigue)

    Changes in fatigue from baseline to immediately after intervention (T1-T2)

  • Cancer-related fatigue (FACIT-fatigue)

    Changes in fatigue from baseline to 3 months after intervention

Secondary Outcomes (10)

  • Pittsburgh Sleep Quality Index (PSQI)

    Immediately after intervention and 3 months after intervention

  • Beck's Depression Inventory - II (BDI-II)

    Immediately after intervention and 3 months after intervention

  • Connors Continous performance test (CPT-3)

    Immediately after intervention

  • Psychomotor vigilance test (PVT)

    Immediately after intervention

  • Hopkins Verbal Learning Test (HVLT-R)

    Immediately after intervention

  • +5 more secondary outcomes

Other Outcomes (6)

  • Mediators: Changes in brain white mater diffusion integrity as measured with diffusion-weighted MR imaging: Diffusion/kurtosis parameters.

    Immediately after intervention

  • Mediators: Changes in Pro-inflammatory cytokines (Il-1, Il-6, Tnf-alpha) (blood draw)

    Changes from baseline to immediately after intervention

  • Mediators: Changes in circadian activity rhythms (actigraphy)

    Changes from baseline to immediately after intervention

  • +3 more other outcomes

Study Arms (2)

Systematic bright light exposure

EXPERIMENTAL

Systematic bright light exposure for 30 min. for 4 weeks

Device: Litebook

Systematic dim light exposure

ACTIVE COMPARATOR

Systematic dim light exposure for 30 min. for 4 weeks

Device: Litebook

Interventions

LitebookDEVICE
Systematic bright light exposureSystematic dim light exposure

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • Low-risk postmenopausal patients as defined by the DBCG having received breast-conserving surgery for lymph node-negative breast cancer
  • +17 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus Universitets Hospital

Aarhus, 8000, Denmark

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cand.psych, Ph.D.

Study Record Dates

First Submitted

December 15, 2015

First Posted

January 22, 2016

Study Start

March 1, 2016

Primary Completion

January 1, 2022

Study Completion

January 1, 2022

Last Updated

June 28, 2024

Record last verified: 2024-06

Locations

DK(1)