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Treating Cancer-Related Fatigue Through Systematic Light Exposure (Light for Fatigue Study)

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ClinicalTrials.gov Identifier: NCT03119363
Recruitment Status : Recruiting
First Posted : April 18, 2017
Last Update Posted : September 24, 2018
Sponsor:
Collaborators:
Memorial Sloan Kettering Cancer Center
University of California, San Diego
Information provided by (Responsible Party):
William H. Redd, Icahn School of Medicine at Mount Sinai

Brief Summary:
Cancer related fatigue (CRF) is the most common cancer side effect and can severely interfere with activities of daily living long after completion of medical treatment. Pharmacologic agents to treat CRF have been studied but there is insufficient evidence to recommend their use. Non-pharmacological interventions for CRF have also been studied but are costly to implement and involve significant patient burden. This study investigates a novel low-cost/ low-burden intervention: systematic light exposure to treat CRF. Two hundred survivors of multiple myeloma and Diffuse Large B-cell Lymphoma between 1 month and 5 years post-autologous stem cell transplant (ASCT) will be recruited from two medical centers. The light will be administered by a small, personal Litebox daily for 4 weeks. Outcomes will be assessed at five separate time points, including baseline and follow-up. The study will specifically address recommendations made for interventions for CRF from the NCI Clinical Trials Planning meeting (JNCI, 2013).The proposed study will: 1) be the first large multisite study with a carefully delineated comparison condition to investigate the effects of light on CRF among ASCT survivors; 2) focus on a distinct, homogenous patient population; 3) include only survivors who experience clinical levels of CRF; and 4) address possible psychological and biological mechanisms. This study will have major public health relevance as it will determine if an easy-to-deliver, inexpensive, and low patient burden intervention effectively reduces CRF.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Fatigue Device: Litebook Edge (Experimental) Device: Litebook Edge (Comparator) Not Applicable

Detailed Description:

The proposed multi-site randomized controlled trial (RCT) will investigate a novel intervention, systematic light exposure (sLE), to treat cancer-related fatigue (CRF) among Multiple Myeloma (MM) and Diffuse Large B-Cell Lymphoma (DLBCL) following autologous stem cell transplantation (ASCT). Cancer related fatigue (CRF) is persistent exhaustion related to cancer and/or its treatment. CRF is the most common cancer side effect and can severely interfere with activities of daily living long after completion of all medical treatment. Pharmacologic agents to treat CRF have been studied but there is insufficient evidence to recommend their use. Non-pharmacological interventions for CRF (including yoga, cognitive behavior therapy, hypnosis, and exercise) have also been studied; however, such interventions are costly to implement and involve significant patient burden. sLE is a low-cost, low- burden intervention that we have found to have beneficial effects for patients post-ASCT. The investigators initial randomized trial for CRF found that certain light exposure was associated with clinically significant reductions in fatigue (effect size d=0.98) More relevant to the proposed research is the preliminary investigation with sLE to treat CRF in MM and DLBCL which found that patients receiving certain sLE reported significantly less fatigue ( p=0.052). The proposed RCT will test the efficacy of sLE on CRF. It will also assess the effect of sLE on sleep, depressive symptoms, and both activity and cortisol circadian rhythms as these related processes have been hypothesized as possible mechanisms of

sLE's effects on CRF. Two hundred survivors of multiple myeloma and Diffuse Large B-cell Lymphoma between 1 month and 5 years post-autologous stem cell transplant (ASCT) will be recruited from two medical centers.

The light will be administered by a small, personal Litebox for 4 weeks. Outcomes will be assessed at five separate time points including baseline and follow-ups.

. The researchers' preliminary research has established the feasibility of this proposal. Moreover, in the preliminary research, 75% of participants completed the preliminary trial and data from the light box compliance meters showed that participants used the light boxes 80% of the days that treatment was scheduled. A large sample of fatigued MM and DLBCL ASCT survivors has been identified. The study will specifically address recommendations made for interventions for CRF from the NCI Clinical Trials Planning meeting (JNCI, 2013). It will: 1) be the first large multisite study with a carefully delineated comparison condition to investigate the effects of light on CRF among cancer survivors treated with ASCT; 2) focus on a distinct, homogenous patient population (MM and DLBCL ASCT survivors); 3) include only survivors who experience clinical levels of CRF; and 4) address possible mechanisms. This RCT will have major public health relevance as it will determine if an easy-to-deliver, inexpensive, and low patient burden intervention reduces CRF.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Potentially eligible ASCT survivors will be identified by HSCT physicians and nurses at each medical center. A research assistant (RA) will be introduced to survivors who express an interest in the research. An RA will explain the study and consent those who are eligible. Once informed consent is obtained, an RA will conduct the screening interview (including the FACIT-Fatigue scale and a psychiatric and sleep disorder screening). An RA will review a checklist of inclusion and exclusion criteria. This information will also be verified by a review of participants' medical charts before participation begins. Eligible study participants will be randomly assigned condition using a block randomization table prepared by our statistician. Participants who do not meet eligibility criteria or who decline participation will be informed that they have completed their participation.
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Treating Cancer-Related Fatigue Through Systematic Light Exposure
Actual Study Start Date : September 1, 2015
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue

Arm Intervention/treatment
Experimental: Experimental Light
The experimental systematic light exposure consists of exposure to light to reduce cancer-related fatigue. This group will self-administer 30 minutes of light from commercially available light boxes each morning for 4 weeks. Outcomes will be assessed through standardized subjective and objective measures at five separate time points including baseline and follow-ups.
Device: Litebook Edge (Experimental)
The Litebook Edge is a small (5" x 5" x 1") and lightweight (4.6 oz.) box designed to be placed on a table about 18" from the participant's head and within 45º visual field. The Litebook uses 60 premium light emitting diode (LED) lights which mimic the visible spectrum of sunlight for minimum glare and maximum eye comfort. For purposes of safety, the Litebook emits no ultraviolet (UV) light.

Active Comparator: Comparison Light
The active comparator condition consists of exposure to light to reduce cancer-related fatigue. This group will self-administer 30 minutes of light from commercially available light boxes each morning for 4 weeks. Outcomes will be assessed through standardized subjective and objective measures at five separate time points including baseline and follow-ups.
Device: Litebook Edge (Comparator)
The Litebook Edge is a small (5" x 5" x 1") and lightweight (4.6 oz.) box designed to be placed on a table about 18" from the participant's head and within 45º visual field. The Litebook uses 60 premium light emitting diode (LED) lights which mimic the visible spectrum of sunlight for minimum glare and maximum eye comfort. For purposes of safety, the Litebook emits no ultraviolet (UV) light.




Primary Outcome Measures :
  1. FACIT-Fatigue Scale [ Time Frame: 4 Years ]
    Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale. 13-item scale, each item 0=not at all to 4=very much, with higher score indicating more fatigue


Secondary Outcome Measures :
  1. Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 4 years ]
    Sleep quality measured subjectively by the PSQI. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.

  2. Rest/activity cycles [ Time Frame: 4 years ]
    Sleep quality measured objectively by actigraphy. Actigraphy is a non-invasive method of monitoring rest/activity cycles.

  3. Center for Epidemiologic Studies Depression Scale (CES-D) [ Time Frame: 4 years ]

    Scoring for All Except Questions 4, 8, 12, and 16:

    • 0 points Rarely or none of the time (< 1 day)
    • 1 point Some or a little of the time (1-2 days)
    • 2 points Occasionally or a moderate amount of the time (3-4 days)
    • 3 points Most or all of the time (5-7 days)

    For questions 4, 8, 12, and 16, the scoring is exactly the same except that it is reversed: "Most or all of the time" is scored 0 points, "Rarely or none of the time" is scored 3 points Screening test score ranges are less than 15 = no depression, 15-21 = mild to moderate depression, and over 21 = possibility of major depression.


  4. Correlation between sLE (or "Experimental Light") and depressive changes [ Time Frame: 4 years ]
    Examine whether the effects of sLE on CRF are mediated by changes in depressive symptoms

  5. Correlation between sLE (or "Experimental Light") and circadian rhythms [ Time Frame: 4 years ]
    Examine whether the effects of sLE on CRF are mediated by changes in rest/activity circadian rhythms.

  6. Correlation between Experimental Light compared with Comparison Light and cortisol circadian rhythm [ Time Frame: 4 years ]
    Examine whether the Experimental Light compared with Comparison Light normalizes cortisol circadian rhythms and whether the effects of sLE on CRF are mediated by changes in cortisol circadian rhythms.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • In remission (partial to complete remission) verified by medical records
  • With a history of ASCT as treatment for hematological malignancies such as MM, DLBCL, and related diseases and who are between three months and five years post-transplant

AND:

-With a score equal to or less than 35 on the FACIT-Fatigue scale (see below)

AND:

-Who are currently over age 18 and were at least age 16 at the time of ASCT

Exclusion Criteria:

  • Under age 18
  • Pregnancy
  • Confounding underlying medical illnesses which may cause fatigue (e.g., severe Anemia not controlled by medication, per self-report corroborated by medical chart review (e.g., Hb<10gm/dl) )
  • Severe sleep disorders (e.g. Narcolepsy)
  • Eye Diseases which limit the ability of light to be processed (e.g., untreated cataracts, glaucoma that causes visual impairment, macular degeneration, blindness, pupil dilation problems or retina damage)
  • Severe psychological impairment (e.g., hospitalization for depressive episode in the past 12 months)
  • Currently employed in night shift work
  • Previous use of light therapy to alleviate fatigue or depressive symptoms
  • Self-reported history of bipolar disorder or manic episodes (which is a contra-indication for light treatment)
  • Severe Psychiatric disorders assessed by the Psychoticism-Paranoia Screener
  • Secondary cancer diagnosis (prior or current) within the past 5 years
  • Plans to travel across meridians during the study

To decrease sample heterogeneity (consistent with JNCI, 2013 recommendations), allogeneic-HSCT survivors will not be eligible for the study.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03119363


Contacts
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Contact: Ariella Hoffman-Peterson, BA 2126595525 ext 85525 ariella.hoffman-peterson@mssm.edu
Contact: Julia Granski, BA 2126595547 ext 85547 julia.granski@mssm.edu

Locations
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United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: William H Redd, PhD    212-659-5515 ext 85515    william.redd@mssm.edu   
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Memorial Sloan Kettering Cancer Center
University of California, San Diego
Investigators
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Principal Investigator: William H Redd, PhD Icahn School of Medicine at Mount Sinai

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Responsible Party: William H. Redd, Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT03119363     History of Changes
Other Study ID Numbers: GCO 14-0937/14-1130
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: September 24, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Keywords provided by William H. Redd, Icahn School of Medicine at Mount Sinai:
cancer-related fatigue
circadian rhythms
light therapy
systematic light exposure
cancer survivors
oncology
Multiple Myeloma
Hematopoietic stem cell transplantation
Autologous stem cell transplantation

Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Fatigue
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Signs and Symptoms