Multiple MyelomaNCT03119363
Treating Cancer-Related Fatigue Through Systematic Light Exposure (Light for Fatigue Study)
A study testing AYO light glasses (Experimental) and AYO light glasses (Comparator) in people with Multiple Myeloma and Fatigue, run by Icahn School of Medicine at Mount Sinai at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Myeloma, Fatigue
- What is being tested?
- AYO light glasses (Experimental) and AYO light glasses (Comparator)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Sep 2015to 1 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 14Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: Treating Cancer-Related Fatigue Through Systematic Light Exposure
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.
Read the 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 light glasses 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.
- Conditions
- Multiple Myeloma, Fatigue
- Being tested
- AYO light glasses (Experimental), AYO light glasses (Comparator)
- Keywords
- cancer-related fatigue, circadian rhythms, light therapy, systematic light exposure, cancer survivors, oncology, Multiple Myeloma, Hematopoietic stem cell transplantation, Autologous stem cell transplantation
- Medical subject headings
- Multiple Myeloma, Fatigue, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: AYO light glasses (Comparator) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 Years
Secondary outcomes (22)
Pittsburgh Sleep Quality Index (PSQI)
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.
Measured: 4 years
Rest/activity cycles
Sleep quality measured objectively by actigraphy. Actigraphy is a non-invasive method of monitoring rest/activity cycles.
Measured: 4 years
Center for Epidemiologic Studies Depression Scale (CES-D)
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.
Measured: 4 years
Correlation between sLE (or "Experimental Light") and depressive changes
Examine whether the effects of sLE on CRF are mediated by changes in depressive symptoms
Measured: 4 years
Correlation between sLE (or "Experimental Light") and circadian rhythms
Examine whether the effects of sLE on CRF are mediated by changes in rest/activity circadian rhythms.
Measured: 4 years
Correlation between Experimental Light compared with Comparison Light and cortisol circadian rhythm
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.
Measured: 4 years
General Anxiety Disorder 7-item questionnaire (GAD-7)
The General Anxiety Disorder 7-item questionnaire (GAD-7) is a 7-item questionnaire that asks user to rank how often they have been bothered by seven problems over the past two weeks from "0" (not at all) to "3" (nearly every day). The items that users are asked to rank levels of nervousness, anxiousness, relaxing, restlessness, irritability and fearfulness. Full scale from 0-21, with higher score indicating more symptoms.
Measured: 4 years
Positive and Negative Affect Schedule (PANAS)
PANAS is a 20-item scale. Each item rated on a 5-point scale of 1 (not at all) to 5 (extremely), each subscale from 10-50, with higher score indicating more symptoms.
Measured: 4 years
Patient Assessment of Own Functioning - PAOFI
Patient Assessment of Own Functioning - PAOFI is a 33-item instrument measuring four areas: memory, language and communication, motor/sensory-perceptual, higher level cognitive, and intellectual functions. Each item is rated from 0 (almost never) to 5 (almost always) for experiencing difficulty. Subscales: memory (0-45), language and communication (0-40), sensory-motor (0-25), intellectual (0-45), with total scale 0-155, with higher score indicating lower functioning
Measured: 4 years
Multidimensional Fatigue Symptom Inventory - Short Form
Multidimensional Fatigue Symptom Inventory - Short Form is a 30-item scale, each item from 1 (not at all) to 4 (extremely), full scale from 24-95, with higher score indicating higher levels of fatigue
Measured: 4 years
The Beck Depression Inventory II (BDI-II)
The Beck Depression Inventory II (BDI-II) is a 21 item self-report inventory measuring the severity of depression. Scoring is from 0 (minimal) to 3 (severe), with total score from 0-63. Higher total scores indicate more severe depressive symptoms.
Measured: 4 years
Impact of Event Scale - Revised (IES-R)
Impact of Event Scale - Revised (IES-R) A 22-item self-report questionnaire measuring PTSD symptoms. Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). The IES-R yields a total score ranging from 0 - 88 with higher score indicating more impact. Not a tool for diagnosis
Measured: 4 years
Self Compassion Scale -SCS
Self Compassion Scale -SCS - 26-item instrument, full score from 1-5, with higher score indicating higher self compassion
Measured: 4 years
Brief Symptom Inventory-18 (BSI-18)
Brief Symptom Inventory-18 (BSI-18) - self-report 18-item instrument. Scores on the 18 items are summarized on the Global Severity Index. Raw scores are converted to t-scores.
Measured: 4 years
Posttraumatic Growth Inventory - (PTGI) Short Form
Posttraumatic Growth Inventory - (PTGI) Short Form - 10-item instrument, each item scored 0 (no change) to 5 (great degree change), full scale from 0-50, with higher score indicating greater growth.
Measured: 4 years
Connor-Davidson Resilience Scale (CD-RISC-10)
The CD-RISC-10 is a 10 item ordinal scale rated on a 5-point scale: 0 (not true at all) to 4 (true nearly all the time). Full scale from 0-40, with higher scores reflecting greater resilience.
Measured: 4 years
The Social Constraints Scale (SCS)
The Social Constraints Scale (SCS) - The SCS is a 15-item measure that reflects social conditions which cause a trauma survivor to feel unsupported, misunderstood, or otherwise alienated from their social network when they are seeking social support or attempting to express trauma-related thoughts, feelings, or concerns. Each item is scored 1 (never) to 4 (always). Full scale from 15-60, with higher score indicating the more often the person perceive they must inhibit themselves from expressing trauma-related thoughts and feelings to others.
Measured: 4 years
C/E- Credibility/Expectancy Questionnaire
C/E- Credibility/Expectancy Questionnaire - A scale measuring treatment expectancy and rationale credibility for use in clinical outcome studies. Full scale from 0-10, with higher score indicating higher treatment expectancy
Measured: 4 years
The Anxiety Sensitivity Index-3 - (ASI-3)
The Anxiety Sensitivity Index-3 - (ASI-3) is an 18 item measure, each item from 0 (very little) to 4 (very much), there are 3 subscales (physical, cognitive, and social) with each subscale range from 0-24 and the full scale range from 0 - 72, with higher scale indicating higher agreement.
Measured: 4 years
MEQ- SA - Morningness Eveningness Questionnaire
MEQ- SA - Morningness Eveningness Questionnaire is a 19 item self-rated instrument to determine morningness-eveningness in human circadian rhythms. Full scale from 16-86, with higher score indicating the more the human circadian rhythm is of morning type.
Measured: 4 years
Perceive Stress Scale (PSS)
Perceive Stress Scale (PSS) - A 10-item questionnaire, each item scored 0 (never) to 4 (very often), full scale from 0-40, with higher score indicating higher perceived stress.
Measured: 4 years
Social Provision Scale
Social Provision Scale - 24 item instrument, each item scored (1) strongly disagree to (4) strongly agree. Full scale from 24 to 96, with higher score indicating higher perception of receiving provision.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start1 Sep 2015
- Primary completion1 Apr 2022
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Memorial Sloan Kettering Cancer Center, Hackensack Meridian Health
- Responsible party
- Principal investigator, William H. Redd, Icahn School of Medicine at Mount Sinai
- Investigators
- William H Redd, PhD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03119363
- Sponsor's protocol ID
- GCO 14-0937/14-1130
- Status last verified
- Jun 2022
- First submitted
- 13 Apr 2017
- Last updated
- 16 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Cancer-Related Fatigue Through Systematic Light Exposure
- ClinicalTrials.gov ID
- NCT03119363
- Acronym / sponsor ID
- GCO 14-0937/14-1130
- Conditions
- Multiple Myeloma, Fatigue
- Keywords
- cancer-related fatigue, circadian rhythms, light therapy, systematic light exposure, cancer survivors, oncology, Multiple Myeloma, Hematopoietic stem cell transplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- Memorial Sloan Kettering Cancer Center, Hackensack Meridian Health
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 18 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 light glasses 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental Light | Experimental | Device: AYO light glasses (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. |
| Comparison Light | Active comparator | Device: AYO light glasses (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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
- -With a score equal to or less than 33 on the FACIT-Fatigue scale (see below)
- -Who are currently over age 18 and were at least age 16 at the time of ASCT
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AYO light glasses (Experimental)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. | Device | Experimental Light |
| AYO light glasses (Comparator)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. | Device | Comparison Light |
Primary outcome
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
22 secondary outcomes
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 4 years
Rest/activity cycles
Time frame: 4 years
Center for Epidemiologic Studies Depression Scale (CES-D)
Time frame: 4 years
Correlation between sLE (or "Experimental Light") and depressive changes
Time frame: 4 years
Correlation between sLE (or "Experimental Light") and circadian rhythms
Time frame: 4 years
Correlation between Experimental Light compared with Comparison Light and cortisol circadian rhythm
Time frame: 4 years
General Anxiety Disorder 7-item questionnaire (GAD-7)
Time frame: 4 years
Positive and Negative Affect Schedule (PANAS)
Time frame: 4 years
Patient Assessment of Own Functioning - PAOFI
Time frame: 4 years
Multidimensional Fatigue Symptom Inventory - Short Form
Time frame: 4 years
The Beck Depression Inventory II (BDI-II)
Time frame: 4 years
Impact of Event Scale - Revised (IES-R)
Time frame: 4 years
Self Compassion Scale -SCS
Time frame: 4 years
Brief Symptom Inventory-18 (BSI-18)
Time frame: 4 years
Posttraumatic Growth Inventory - (PTGI) Short Form
Time frame: 4 years
Connor-Davidson Resilience Scale (CD-RISC-10)
Time frame: 4 years
The Social Constraints Scale (SCS)
Time frame: 4 years
C/E- Credibility/Expectancy Questionnaire
Time frame: 4 years
The Anxiety Sensitivity Index-3 - (ASI-3)
Time frame: 4 years
MEQ- SA - Morningness Eveningness Questionnaire
Time frame: 4 years
Perceive Stress Scale (PSS)
Time frame: 4 years
Social Provision Scale
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2022.
- Individual participant dataSharing planned: No
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Multiple Myeloma, Lymphoma, Non-Hodgkin
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William H Redd, PhD principal investigator
Icahn School of Medicine at Mount Sinai
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AYO light glasses (Experimental) and AYO light glasses (Comparator) in people with Multiple Myeloma and Fatigue, run by Icahn School of Medicine at Mount Sinai at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FACIT-Fatigue Scale (time frame: 4 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2022.