Clinical trial NCT01873794: Treating Cancer-Related Fatigue Through Systematic Light Exposure
Official title: Treating Cancer-Related Fatigue Through Systematic Light Exposure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hematopoietic Stem Cell Transplantation
Breast Cancer
Fatigue
Mild Cognitive Impairment
Light
Quality of Life
Sleep
Keywords: Fatigue
Sleep
Quality of life
Cancer
Light
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: University of California, San Diego
name: Hackensack Meridian Health
First posted: 2013-06-10
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

Patients:

* With a history of HSCT as treatment for hematological malignancies and related diseases and who are up to 3.5 years post-transplant; OR
* Who are up to three and a half years post completion of chemotherapy OR chemotherapy and radiation for breast cancer with a curative intent;

AND:

* With a score equal to or less than 33 on the FACIT-Fatigue scale (see below) and no pre-existing anemia (Hb\<10gm/dl); or a score equal to or greater than 43 on the Cognitive Failures Questionnaire
* Who are currently over age 18 and at least age 16 at the time of HSCT or time of breast cancer treatment

Exclusion Criteria:

* Under age 18;
* Pregnancy;
* Confounding underlying medical illnesses;
* History of mania (which is a contra-indication for light treatment) or current clinical depression;
* And any other physical or psychological impairments including a sleep disorder diagnosis which would limit participation.

Primary outcomes:
measure: FACIT-Fatigue Scale
timeFrame: Baseline
measure: FACIT-Fatigue Scale
timeFrame: at 4 weeks
measure: FACIT-Fatigue Scale
timeFrame: at 3 months follow up
Secondary outcomes:
measure: The Pittsburgh Sleep Quality Index
timeFrame: Baseline
measure: The Pittsburgh Sleep Quality Index
timeFrame: at 4 weeks
measure: The Pittsburgh Sleep Quality Index
timeFrame: at 3 months follow up
measure: SF-36 Scale
timeFrame: Baseline
measure: SF-36 Scale
timeFrame: at 4 weeks
measure: SF-36 Scale
timeFrame: at 3 months follow up
measure: CNS-Vital Signs
timeFrame: Baseline
measure: CNS-Vital Signs
timeFrame: at 4 weeks
measure: CNS-Vital Signs
timeFrame: at 3 months follow up
measure: The Cognitive Failures Questionnaire
timeFrame: Baseline
measure: The Cognitive Failures Questionnaire
timeFrame: at 4 weeks
measure: The Cognitive Failures Questionnaire
timeFrame: at 3 months follow up
measure: Brief Symptom Inventory-18
timeFrame: Baseline
measure: Brief Symptom Inventory-18
timeFrame: at 4 weeks
measure: Brief Symptom Inventory-18
timeFrame: at 3 months follow up
measure: Actiwatch Spectrum
timeFrame: Baseline
measure: Actiwatch Spectrum
timeFrame: at 4 weeks
measure: Actiwatch Spectrum
timeFrame: at 3 months follow up
Other outcomes:
Locations:
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: William H Redd, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wu LM, Amidi A, Valdimarsdottir H, Ancoli-Israel S, Liu L, Winkel G, Byrne EE, Sefair AV, Vega A, Bovbjerg K, Redd WH. The Effect of Systematic Light Exposure on Sleep in a Mixed Group of Fatigued Cancer Survivors. J Clin Sleep Med. 2018 Jan 15;14(1):31-39. doi: 10.5664/jcsm.6874.