Effect of Increased Light Exposure on Fatigue in Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
California Breast Cancer Research Program
Information provided by (Responsible Party):
Sonia Ancoli-Israel, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00478257
First received: May 22, 2007
Last updated: February 26, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention
Breast Cancer
Device: light box ( Litebook)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Effect of Increased Light Exposure on Fatigue in Breast Cancer

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • fatigue, sleep, quality of life [ Time Frame: four cycles of chemotherapy ] [ Designated as safety issue: No ]

Enrollment: 39
Study Start Date: November 2005
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Bright white light
Device: light box ( Litebook)
bright white light
Other Name: Litebook
Active Comparator: 2
dim red light
Device: light box ( Litebook)
dim red light
Other Name: Litebook

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 -
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00478257

Locations
United States, California
Moores UCSD Cancer Center
San Diego, California, United States, 92093
Sponsors and Collaborators
University of California, San Diego
California Breast Cancer Research Program
Investigators
Principal Investigator: Sonia Ancoli-Israel, PhD University of California, San Diego
  More Information

Publications:
Responsible Party: Sonia Ancoli-Israel, Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT00478257     History of Changes
Other Study ID Numbers: CBCRP 11IB-0034
Study First Received: May 22, 2007
Last Updated: February 26, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Diego:
fatigue
sleep
quality of life
light
cancer

Additional relevant MeSH terms:
Fatigue
Breast Neoplasms
Signs and Symptoms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on October 01, 2014