The Ambient Light Multiple Myeloma Study
ConditionMultiple Myeloma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorIcahn School of Medicine at Mount Sinai
About this trial
The aim of this multi-site randomized control trial will be is to assess the impact Systematic lighting on circadian rhythm entrainment, Inflammation, Neutropenic Fever and Symptom Burden among Multiple Myeloma Patients undergoing Autologous Stem Cell Transplantation. To achieve this aim, 200 multiple myeloma patients will receive one of two different light-treatments that are designed to promote circadian rhythm alignment. While receiving these light treatments, participants' sleep efficiency, urine melatonin levels, blood inflammatory cytokine levels and symptoms will be assessed over a 2-month period.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Multiple Myeloma diagnosis
Scheduled to undergo their first Autologous Stem Cell Transplant procedure.
21years or older
Able to provide informed consent.
Disqualifiers
Previous Autologous Stem Cell Transplant procedure
Pregnancy
Eye diseases which limit the ability of light to be processed
Secondary cancer diagnosis within the last 5 years
Trial design
Design model
Parallel
Treatments tested in this trial
Circadian Effective Lighting
DeviceParticipants will receive lighting with a spectrum of 300K, 500 lux to the eye level between 7:00am and 10:00am in the morning, and hospital lighting (\<100lux) during the afternoon between 10:00am and 6:00pm. In the evening this group of participants will receive lighting with a spectrum of 3000K, \<50lux at eye light level between 6:00PM and bedtime.
Circadian Ineffective Lightning (CIL)
DeviceParticipants will receive lower lighting levels in the morning (lighting with A spectrum of 300k, \<50lux to the eye level between 7:00am and 10:00am) and the same lighting levels throughout the rest of the day.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Circadian Effective Lighting (CEL)Active comparator 1 intervention
Group B: Circadian Ineffective Lighting (CIL)Sham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Changes in Urinary Melatonin
Participants will be given vials for collection and detailed instructions to void their bladders on AM rising and any prior nighttime voids starting 2 h prior to their normal bedtimes, at which time they will be asked to dim the lights down to a minimum and avoid using their self-luminous displays. Participants (and nurses) will collect each void during that overnight in a separate vial and to record the times of each voiding. Urinary melatonin-sulfate (6 sulfatoxymelatonin, aMT6s) measurements will be assayed using a commercially available ELISA kit (IBL International, Hamburg, Germany).
Time frame
Baseline visit and 3 days after the Autologous Stem Cell TransplantSecondary outcomes
1
Sleep Efficiency using Actigraphy at 7 days post-transplant
The participant will be asked to wear a wrist actigraph to monitoring sleep and activity, daily for 5 consecutive days. From the actigraphy data, change in sleep efficiency will be calculated. A higher sleep efficiency indicates improved sleep.
Time frame
at 7 days post-transplant2
Sleep Efficiency using Actigraphy at 3 days after engraftment
The participant will be asked to wear a wrist actigraph to monitoring sleep and activity, daily for 5 consecutive days. From the actigraphy data, change in sleep efficiency will be calculated. A higher sleep efficiency indicates improved sleep.
Time frame
at 3 days after engraftment3
Sleep Efficiency using Actigraphy at 4 weeks after engraftment
The participant will be asked to wear a wrist actigraph to monitoring sleep and activity, daily for 5 consecutive days. From the actigraphy data, change in sleep efficiency will be calculated. A higher sleep efficiency indicates improved sleep.
Time frame
at 4 weeks after engraftment4
Inflammatory cytokine CRP levels at Baseline
A blood sample will be drawn to measure Inflammatory cytokine CRP levels. A decrease in CRP levels indicates reduced inflammation.
Time frame
At baseline, or during the hospital visit prior to transplantSponsors and contacts
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Source ClinicalTrials.gov