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Treating Cancer-Related Fatigue Through Systematic Light Exposure

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Mount Sinai Health System

Status

Completed

Conditions

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

Treatments

Device: Dim red light
Device: Bright white light

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT01873794
GCO 10-0864
5R21CA158954 (U.S. NIH Grant/Contract)
HSM#11-01032

Details and patient eligibility

About

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.

Full 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.

Enrollment

54 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

54 participants in 2 patient groups

Bright white light
Active Comparator group
Description:
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
Treatment:
Device: Bright white light
Dim red light
Active Comparator group
Description:
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
Treatment:
Device: Dim red light

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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