Treating Cancer-Related Fatigue Through Systematic Light Exposure

NCT ID: NCT01873794

Last Updated: 2017-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2014-07-31

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.

Conditions

Hematopoietic Stem Cell Transplantation; Breast Cancer; Fatigue; Mild Cognitive Impairment; Light; Quality of Life; Sleep

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Bright white light

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

Group Type: ACTIVE_COMPARATOR

Bright white light

Intervention Type: DEVICE

Dim red light

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

Group Type: ACTIVE_COMPARATOR

Dim red light

Intervention Type: DEVICE

Interventions

Bright white light

Intervention Type: DEVICE

Dim red light

Intervention Type: DEVICE

Other Intervention Names

Light Box; Litebook; Light Box; Litebook

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: collaborator

Hackensack Meridian Health

OTHER

Sponsor Role: collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William H Redd, PhD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Hackensack University Medical Center

Hackensack, New Jersey, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 29198295 (View on PubMed)

Other Identifiers

5R21CA158954

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HSM#11-01032

Identifier Type: -

Identifier Source: secondary_id

GCO 10-0864

Identifier Type: -

Identifier Source: org_study_id