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

NCT03119363 | Completed

• 1 other identifier: GCO 14-0937/14-1130
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 3

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 three medical centers. The light will be administered by a small, personal light glasses 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.

Conditions

Multiple Myeloma; Fatigue

Keywords

cancer-related fatigue; circadian rhythms; light therapy; systematic light exposure; cancer survivors; oncology; Multiple Myeloma; Hematopoietic stem cell transplantation; Autologous stem cell transplantation

Outcome Measures

Primary Outcomes (1)

• FACIT-Fatigue Scale

  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

  4 Years

Secondary Outcomes (22)

• Pittsburgh Sleep Quality Index (PSQI)

  4 years

• Rest/activity cycles

  4 years

• Center for Epidemiologic Studies Depression Scale (CES-D)

  4 years

• Correlation between sLE (or "Experimental Light") and depressive changes

  4 years

• Correlation between sLE (or "Experimental Light") and circadian rhythms

  4 years

Study Arms (2)

Experimental Light

EXPERIMENTAL

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 glasses (AYO) each morning for 4 weeks. The AYO light glasses is a lightweight pair of glasses that emits light from LEDs at a distance of 15 millimeters (15mm, 0.015m) from the eye.

Device: AYO light glasses (Experimental)

Comparison Light

ACTIVE COMPARATOR

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 glasses each morning for 4 weeks.

Device: AYO light glasses (Comparator)

Interventions

AYO light glasses (Experimental) DEVICE

The AYO does not contain UV or infra-red light; the light spectrum begins at approximately 420nm. The circadian-effective AYO is programed at over 100 lux with 470nm frequency and irradiance of 250 qW/cm2, which is 100% intensity level. Irradiance over lux itself with AYO light glasses is believed to be more representative due to light frequency and proximity to the eye. Traditional Lightbox usual measure is Lux , AYO can be seen as comparable to 1,000 lux light box. The device is classified as a device that is safe for the eyes in accordance with the international standard IEC 62471 and is independently certified by TÜV Rheinland. AYO complies with the EU's CE marking (CE EMC EN 55014, EN 61000-4-3) as well as other national regulatory directives. AYO also complies with the United States of America's FCC marking (FCC Title 47, Chapter 1, Part 15, Class B FCC VOC: 47 CFR PART 15 OCT, 2016. CLASS B ANSI C 63.4: 2014) as well as other national marking regulatory directives.

Experimental Light

AYO light glasses (Comparator) DEVICE

The comparison group will wear the same AYO glasses, but with a circadian ineffective (sham) light. The circadian-ineffective (sham) is programed at 1% intensity, therefore according to our calculation and checks it is below circadian threshold of 2 lux as specified.

Comparison Light

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 one month and five years post-transplant
• AND:
• With a score equal to or less than 33 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

You may not qualify if:

• COVID diagnoses (active COVID-19) at the time of recruitment
• 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.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Memorial Sloan Kettering Cancer Center: collaborator
• Hackensack Meridian Health: collaborator

Study Sites (3)

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Multiple Myeloma; Fatigue; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• William H Redd, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: April 13, 2017
• First Posted: April 18, 2017
• Study Start: September 1, 2015
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: June 16, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)