Treating Cancer-Related Fatigue Through Systematic Light Exposure

Breast Cancer Clinical Trial

Official title:

Treating Cancer-Related Fatigue Through Systematic Light Exposure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01873794
• Other study ID #: GCO 10-0864
• Secondary ID: 5R21CA158954HSM#
• Status: Completed
• Phase: N/A
• First received: June 6, 2013
• Last updated: April 7, 2017
• Start date: January 2012
• Est. completion date: July 2014

Study information

• Verified date: April 2017
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Device:
• Bright white light

• Dim red light

Locations

Country	Name	City	State
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (4)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	Hackensack University Medical Center, National Cancer Institute (NCI), University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FACIT-Fatigue Scale	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	Baseline
Primary	FACIT-Fatigue Scale	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.	at 4 weeks
Primary	FACIT-Fatigue Scale	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.	at 3 months follow up
Secondary	The Pittsburgh Sleep Quality Index	The validity of the instrument is based on its ability to discriminate patients (those having either sleep problems and/or depressive symptoms) from controls (healthy participants without sleep complaints). Baseline, second week of light box use, fourth (last) week of light box use, three weeks post completion of light box use	Baseline
Secondary	The Pittsburgh Sleep Quality Index	The validity of the instrument is based on its ability to discriminate patients (those having either sleep problems and/or depressive symptoms) from controls (healthy participants without sleep complaints).	at 4 weeks
Secondary	The Pittsburgh Sleep Quality Index	The validity of the instrument is based on its ability to discriminate patients (those having either sleep problems and/or depressive symptoms) from controls (healthy participants without sleep complaints.	at 3 months follow up
Secondary	SF-36 Scale	Quality of life will be assessed using the SF-36 scale. The SF-36 is a multi-purpose, short form health survey consisting of 36 questions.	Baseline
Secondary	SF-36 Scale	Quality of life will be assessed using the SF-36 scale. The SF-36 is a multi-purpose, short form health survey consisting of 36 questions.	at 4 weeks
Secondary	SF-36 Scale	Quality of life will be assessed using the SF-36 scale. The SF-36 is a multi-purpose, short form health survey consisting of 36 questions.	at 3 months follow up
Secondary	CNS-Vital Signs	Objective cognitive function will be assessed using CNS-Vital Signs, a reliable and valid computer-administered cognitive assessment battery that consists of 7 cognitive tests.	Baseline
Secondary	CNS-Vital Signs	Objective cognitive function will be assessed using CNS-Vital Signs, a reliable and valid computer-administered cognitive assessment battery that consists of 7 cognitive tests.	at 4 weeks
Secondary	CNS-Vital Signs	Objective cognitive function will be assessed using CNS-Vital Signs, a reliable and valid computer-administered cognitive assessment battery that consists of 7 cognitive tests.	at 3 months follow up
Secondary	The Cognitive Failures Questionnaire	A 25-item self-report measure of cognitive difficulties in everyday life using a 5-point Likert scale.	Baseline
Secondary	The Cognitive Failures Questionnaire	A 25-item self-report measure of cognitive difficulties in everyday life using a 5-point Likert scale.	at 4 weeks
Secondary	The Cognitive Failures Questionnaire	A 25-item self-report measure of cognitive difficulties in everyday life using a 5-point Likert scale.	at 3 months follow up
Secondary	Brief Symptom Inventory-18	Used to assess psychological distress. A list of health problems and complaints that people sometimes experience are listed.	Baseline
Secondary	Brief Symptom Inventory-18	Used to assess psychological distress. A list of health problems and complaints that people sometimes experience are listed.	at 4 weeks
Secondary	Brief Symptom Inventory-18	Used to assess psychological distress. A list of health problems and complaints that people sometimes experience are listed.	at 3 months follow up
Secondary	Actiwatch Spectrum	Sleep/wake activity is measured using an actigraph which records physical movement and detects light. The Actiwatch is worn for 72 consecutive hours.	Baseline
Secondary	Actiwatch Spectrum	Sleep/wake activity is measured using an actigraph which records physical movement and detects light. The Actiwatch is worn for 72 consecutive hours.	at 4 weeks
Secondary	Actiwatch Spectrum	Sleep/wake activity is measured using an actigraph which records physical movement and detects light. The Actiwatch is worn for 72 consecutive hours.	at 3 months follow up