Breast Cancer
Conditions
Keywords
fatigue, sleep, quality of life, light, cancer
Brief summary
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.
Detailed description
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.
Interventions
DEVICEbright white light
Intervention: Bright white light administered for 30 minutes each morning
DEVICEcomparator red light treatment
dim red light administered for 30 minutes every morning
Sponsors
California Breast Cancer Research Program
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* stage I-III breast cancer * adjuvant or neoadjuvant anthracycline-based chemotherapy
Exclusion criteria
* under age 18 * pregnancy * metastatic or inoperable (including inflammatory) breast cancer * confounding underlying medical illnesses * history of mania * history of other axis-I psychiatric disorder * other physical or psychological impairments -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue | four cycles of chemotherapy | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Effect of Bright Light Effect of bright light on fatigue in women with breast cancer | 23 |
| Effect of Red Light effect of red light on fatigue in women with breast cancer | 16 |
| Total | 39 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 8 | 3 |
Baseline characteristics
| Characteristic | Effect of Red Light | Effect of Bright Light | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 4 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 19 Participants | 34 Participants |
| Age, Continuous | 53.5 years STANDARD_DEVIATION 9 | 54.3 years STANDARD_DEVIATION 9 | 53.9 years STANDARD_DEVIATION 9 |
| Region of Enrollment United States | 16 participants | 23 participants | 39 participants |
| Sex: Female, Male Female | 16 Participants | 23 Participants | 39 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 23 | 0 / 16 |
| serious Total, serious adverse events | 0 / 23 | 0 / 16 |
Outcome results
Primary
Fatigue
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.
Time frame: four cycles of chemotherapy
Population: All participants that were randomized and began the protocol were included in analyses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Effect of Bright Light | Fatigue | 15.25 units on a scale | Standard Error 5.5 |
| Effect of Red Light | Fatigue | 21.6 units on a scale | Standard Error 7.2 |