Effect of Increased Light Exposure on Fatigue in Breast Cancer

Breast Cancer Clinical Trial

Official title:

Effect of Increased Light Exposure on Fatigue in Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00478257
• Other study ID #: CBCRP 11IB-0034
• Status: Completed
• Phase: N/A
• Start date: November 2005
• Est. completion date: November 2009

Study information

• Verified date: January 2019
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 -

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Fatigue

Intervention

Device:
• bright white light
Intervention: Bright white light administered for 30 minutes each morning
• comparator red light treatment
dim red light administered for 30 minutes every morning

Locations

Country	Name	City	State
United States	Moores UCSD Cancer Center	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	California Breast Cancer Research Program

Country where clinical trial is conducted

United States, 

References & Publications (3)

Ancoli-Israel S, Rissling M, Neikrug A, Trofimenko V, Natarajan L, Parker BA, Lawton S, Desan P, Liu L. Light treatment prevents fatigue in women undergoing chemotherapy for breast cancer. Support Care Cancer. 2012 Jun;20(6):1211-9. doi: 10.1007/s00520-01 — View Citation

Jeste N, Liu L, Rissling M, Trofimenko V, Natarajan L, Parker BA, Ancoli-Israel S. Prevention of quality-of-life deterioration with light therapy is associated with changes in fatigue in women with breast cancer undergoing chemotherapy. Qual Life Res. 201 — View Citation

Neikrug AB, Rissling M, Trofimenko V, Liu L, Natarajan L, Lawton S, Parker BA, Ancoli-Israel S. Bright light therapy protects women from circadian rhythm desynchronization during chemotherapy for breast cancer. Behav Sleep Med. 2012;10(3):202-16. doi: 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	four cycles of chemotherapy