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Treating Cancer-Related Fatigue Through Systematic Light Exposure


N/A
18 Years
N/A
Open (Enrolling)
Both
Hematopoietic Stem Cell Transplantation, Breast Cancer, Fatigue, Mild Cognitive Impairment, Light, Quality of Life, Sleep

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Trial Information

Treating Cancer-Related Fatigue Through Systematic Light Exposure


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Outcome Measure:

FACIT-Fatigue Scale

Outcome Description:

A list of statements that patients with cancer have said about their fatigue will be read. Subjects will mark on a 5-point scale how often they have felt each statement over the last 7 days. Measured at baseline, second week of light box use, fourth (last) week of light box use, three weeks post completion of light box use

Outcome Time Frame:

Baseline

Safety Issue:

No

Principal Investigator

William H Redd, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Icahn School of Medicine at Mount Sinai

Authority:

United States: Institutional Review Board

Study ID:

GCO 10-0864

NCT ID:

NCT01873794

Start Date:

January 2012

Completion Date:

January 2014

Related Keywords:

  • Hematopoietic Stem Cell Transplantation
  • Breast Cancer
  • Fatigue
  • Mild Cognitive Impairment
  • Light
  • Quality of Life
  • Sleep
  • Fatigue
  • Sleep
  • Quality of life
  • Cancer
  • Light
  • Breast Neoplasms
  • Fatigue
  • Cognition Disorders

Name

Location
Hackensack University Medical Center Hackensack, New Jersey  07601
Icahn School of Medicine at Mount Sinai New York, New York  10029