Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02661308 : Reducing Cancer Side-effects With Systematic Light Exposure
PhaseN/A
AgesMin: 18 Years Max: N/A
Eligibility
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
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02661308      |      Link to official Clinicaltrials.gov listing
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