Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Behaviors and Mental Disorders

Breast Neoplasms

Fatigue

Breast Diseases

Skin Diseases

Quality of Life

Intervention: Bright white light, the intervention, was administered via a light box made by Litebook Inc for 30 minutes each morning during four cycles of chemotherapy

Intervention: Dim red light, the intervention, was administered via a light box made by Litebook Inc for 30 minutes each morning during four cycles of chemotherapy

Intervention: Bright white light administered for 30 minutes each morning

bright white light

dim red light administered for 30 minutes every morning

comparator red light treatment

Sonia Ancoli-Israel, PhD

Patients treated with chemotherapy complain of poor sleep, fatigue and depression. In addition, chemotherapy disrupts the body's internal "biological clock", which may make sleep, fatigue and depression all worse. Women with breast cancer undergoing chemotherapy are not exposed to much bright light and this may also contribute to the disruption of their body clock, because bright light is necessary for a strong biological clock. One of the easiest ways to strengthen the biological clock is by increasing bright light exposure. The correct timing of the light exposure will help the women feel more alert during the day.

Patients treated with chemotherapy complain of poor sleep, fatigue and depression. Our preliminary research suggests that these symptoms may all be related, that chemotherapy disrupts circadian rhythms which may exacerbate the poor sleep and fatigue and that during chemotherapy, women are not exposed to much bright light which likely also contributes to the disruption of rhythms. One of the easiest circadian rhythms to measure is sleep/wake activity and the easiest way to synchronize this rhythm is with bright light treatment. It is well established that bright light exposure will make rhythms more robust, and the correct timing of the light exposure will have an alerting effect.

We hypothesize that after bright light treatment compared to dim light treatment during three cycles of chemotherapy: fatigue (measured by the Multidimensional Fatigue Symptom Inventory), depression (measured by the Center of Epidemiological Studies-Depression scale), functional outcome scores (measured by the Functional Outcome of Sleep Questionnaire and by the Functional Assessment of Cancer Therapy-Breast), and sleep measures (measured by actigraphy, e.g., total sleep time, total wake time, bouts of sleep, napping) will all be improved. We also hypothesize that circadian rhythms (measured by actigraphy) will be more robust and more synchronized.

The aims are to examine the effect of bright light treatment on subjective measures of fatigue, mood and functional outcome experienced during chemotherapy, to examine the effect of bright light treatment on the quality and quantity of sleep during chemotherapy, to examine the effect of bright light treatment on sleep/wake rhythms during chemotherapy. Women with breast cancer stages I-III scheduled to begin chemotherapy will be recruited. Wrist actigraphy data (for the measurement of sleep/wake activity) will be collected for three consecutive days and nights immediately preceding chemotherapy and questionnaire data (fatigue, mood, quality of life, functional outcome, sleep) will be collected during this same time period. Half the women will be randomized to receive bright light and the other half to dim red light as a control. Daily bright light or dim light treatment will be administered during cycles 2, 3 and 4 of chemotherapy and all measures (actigraphy and questionnaires) will be repeated during the first and last weeks of cycle 1 and cycle 4 chemotherapy. If bright light can improve sleep rhythms and fatigue, then the quality of life of these women is likely to improve.

Effect of Increased Light Exposure on Fatigue in Breast Cancer

The Short Form of the Multidimensional Fatigue Symptom Inventory (MFSI-sf) was used to measure fatigue. The range of possible score for each subscale is 0 to 24, and the range for total score is -24 to 96, with a higher score indicating more severe fatigue, except for the Vigor subscale, where larger score indicates less fatigue.

California Breast Cancer Research Program

University of California, San Diego

Professor

Effect of bright light on fatigue in women with breast cancer

Effect of Bright Light

effect of red light on fatigue in women with breast cancer

Effect of Red Light

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Small sample size; only partial compliance data; light only administered in morning; only tested effect in patients with breast cancer.

Dr. Sonia Ancoli-Israel

All participants that were randomized and began the protocol were included in analyses.

Overall Study

Cognitive Dysfunction

Cognition Disorders

Neurocognitive Disorders

Mental Disorders

Psychotic Disorders

using systematic light exposure (SLE), consisting of a daily 30-minute exposure to as much as 10,000 lux of light from a commercially available light box

Bright white light

Dim red light

William H Redd, PhD

Cancer related fatigue (CRF) - a persistent sense of exhaustion related to cancer or cancer treatment - can severely interfere with activities of daily living, and has even been reported to be a factor in patient requests for hastened death. CRF can represent a serious clinical problem years after all treatment has ended. There is currently no effective treatment for CRF. The purpose of this study is to investigate whether systematic exposure to light (from a commercially available Litebook) reduces CRF or other symptoms.

Cancer related fatigue (CRF) - a persistent sense of exhaustion related to cancer or cancer treatment - can severely interfere with activities of daily living, and has even been reported to be a factor in patient requests for hastened death. CRF can represent a serious clinical problem years after all treatment has ended. In our research with cancer survivors 1 to 3 years after completion of hematopoietic stem cell transplant (HSCT), 40% of those we interviewed reported that CRF was a major obstacle to the resumption of usual activities. Despite its impact on quality of life, CRF is under-reported, under-diagnosed, and under-treated.

A variety of pharmacologic agents have been studied to treat CRF, but there is insufficient evidence to recommend their use. The most promising non-pharmacologic interventions -- exercise and cognitive-behavior therapy (CBT) -- have shown equally modest effects. The proposed study focuses on a promising new intervention for CRF, using systematic light exposure (SLE), consisting of a daily 30-minute exposure to as much as 10,000 lux of light from a commercially available light box. Study collaborator, Ancoli-Israel and her colleagues have successfully piloted this line of research with breast cancer patients undergoing chemotherapy.

The goal of this study will be to assess the effect of SLE on long-term HSCT and breast cancer survivors, and to determine the feasibility and acceptability of SLE as an intervention for CRF. The approach will be informed by the procedures that Ancoli-Israel and her colleagues developed for their research on SLE treatment for breast cancer chemotherapy, as well as by Redd's studies of CBT to treat adjustment disorders in survivors of HSCT. The study arms will test the efficacy of two different types of light treatment, bright white light and dim red light. Outcomes will be assessed through standardized measures of CRF, sleep quality, and quality of life.

Treating Cancer-Related Fatigue Through Systematic Light Exposure

A list of statements that patients with cancer have said about their fatigue will be read. Subjects will mark on a 5-point scale how often they have felt each statement over the last 7 days. Measured at baseline, second week of light box use, fourth (last) week of light box use, three weeks post completion of light box use

A list of statements that patients with cancer have said about their fatigue will be read. Subjects will mark on a 5-point scale how often they have felt each statement over the last 7 days.

The validity of the instrument is based on its ability to discriminate patients (those having either sleep problems and/or depressive symptoms) from controls (healthy participants without sleep complaints). Baseline, second week of light box use, fourth (last) week of light box use, three weeks post completion of light box use

The validity of the instrument is based on its ability to discriminate patients (those having either sleep problems and/or depressive symptoms) from controls (healthy participants without sleep complaints).

The validity of the instrument is based on its ability to discriminate patients (those having either sleep problems and/or depressive symptoms) from controls (healthy participants without sleep complaints.

Quality of life will be assessed using the SF-36 scale. The SF-36 is a multi-purpose, short form health survey consisting of 36 questions.

Objective cognitive function will be assessed using CNS-Vital Signs, a reliable and valid computer-administered cognitive assessment battery that consists of 7 cognitive tests.

A 25-item self-report measure of cognitive difficulties in everyday life using a 5-point Likert scale.

Used to assess psychological distress. A list of health problems and complaints that people sometimes experience are listed.

Sleep/wake activity is measured using an actigraph which records physical movement and detects light. The Actiwatch is worn for 72 consecutive hours.

National Cancer Institute (NCI)

Hackensack Meridian Health

Icahn School of Medicine at Mount Sinai

Bright white light exposure every morning for 30 minutes for 28 consecutive days

Dim red light exposure every morning for 30 minutes for 28 consecutive days

Tavis S Campbell, PhD

Cancer-related fatigue is one of the most common and distressing symptoms associated with a cancer diagnosis.Fatigue related to cancer often appears before a diagnosis, worsens during treatment, and lasts for years after treatment in up to 35% of patients. Despite the long-term effects of cancer-related fatigue, the treatment options available are not always appropriate or helpful for all patients.Light therapy is an effective treatment for other disorders related to fatigue. The purpose of the study is to investigate the role of light therapy on quality of life, sleep patterns, and physical measures of immune function and stress hormones in individuals with post-treatment cancer-related fatigue.

An Investigation of Light Therapy for Cancer-related Fatigue (The LITE Study)

A Randomized Controlled Trial of Light Therapy on Biomarkers, Sleep/Wake Activity, and Quality of Life in Individuals With Post-treatment Cancer-related Fatigue

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effect of Increased Light Exposure on Fatigue in Breast Cancer	NCT00478257	Breast Cancer	bright white li... comparator red ...	18 Years -	University of California, San Diego
Treating Cancer-Related Fatigue Through Systematic Light Exposure	NCT01873794	Hematopoietic S... Breast Cancer Fatigue Mild Cognitive ... Light Quality of Life Sleep	Bright white li... Dim red light	18 Years -	Icahn School of Medicine at Mount Sinai
An Investigation of Light Therapy for Cancer-related Fatigue (The LITE Study)	NCT01780623	Cancer	Bright white li... Dim red light	18 Years - 65 Years	University of Calgary

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