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.

The Ambient Light Multiple Myeloma Study

Multiple Myeloma

Individuals undergoing Autologous Stem Cell Transplant (ASCT) experience major
      transplant-related complications including elevated symptom burden, high rates of neutropenic
      fever, and increases in inflammatory cytokines. These transplant-related complications are
      augmented by circadian rhythms disruption (CRD), which leads to misalignment between
      melatonin levels and sleep times. Since light is a strong synchronizer of circadian rhythms,
      the proposed multi-site randomized controlled trial (RCT) will investigate whether lighting
      designed to deliver circadian effective light that promotes circadian alignment, will: 1)
      promote higher nighttime melatonin levels and better nighttime sleep, 2) reduce
      pro-inflammatory cytokines, 3) lower rates of neutropenic fever and 4) improve symptom burden
      in cancer patients undergoing Autologous Stem Cell Transplant.

      Hospital rooms for patients undergoing inpatient Autologous Stem Cell Transplant at the Mount
      Sinai Medical Center (MSMC) and at the Memorial Sloan Kettering Cancer Center (MSKCC)) will
      be retrofitted to install 1 of 2 lighting interventions, either circadian-effective
      (intervention) and circadian-ineffective (comparison) ambient light that may improve sleep.

      1-2 weeks and no more than 2 months prior to transplant, participants will be given an
      Actiwatch, Daysimeter (personal light meter), sleep logs, questionnaires, and a urine
      collection kit to assess melatonin. One blood sample for cytokine analyses will be collected
      during one of the hospital visits prior to transplant. Blood draws are always done in the
      morning and always at a similar time for the same individual. The same outcomes
      (questionnaires, Actiwatch, Daysimeter, urine samples, blood samples) will be collected
      during transplant period and once, four weeks after engraftment.

Circadian Effective Lighting

Circadian Ineffective Lightning (CIL)

Systematic Light Exposure Effects on Circadian Rhythms Entrainment, Inflammation, Neutropenic Fever and Symptom Burden Among Multiple Myeloma Patients Undergoing Autologous Stem Cell Transplantation

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).

Professor, Director of Light and Health Research Center at Mount Sinai

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.

A blood sample will be drawn to measure Inflammatory cytokine CRP levels. A decrease in CRP levels indicates reduced inflammation.

Physician notes on patient neutropenic fever will be obtained from medical records. Neutropenic fever will be defined as temperature of 38.2 C or higher and an absolute neutrophil count of less than 500 cells/mm. Physician notes are reviewed, and the number of times neutropenic fever is reported for each participant is recorded.

Participants will be asked to wear Daysimeters as a pendant or a pin during all waking times during the intervention weeks. Light measurements from Daysimeters used as pendants or pins are the closest to light measurements at eye level. The Daysimeter will also be used to monitor the total amount of circadian light received by the participant during the intervention weeks.

MDASI-MM, with well-established reliability and validity, is 19-item measure of cancer-related symptom burden. It assesses 13 core symptoms common across cancer types and treatments (pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, difficulty remembering, lack of appetite, drowsiness, dry mouth, sadness, vomiting, and numbness/tingling). In addition, 6 items assess symptom-related interference. All 19 items are rated with reference to "the last 24 hours" on a scale from 0 to 10 with anchors at the extreme ends of the scale (for symptom items, 0 = "Not Present" and 10 = "As Bad As You Can Imagine"; for interference items 0 = "Did Not Interfere" and 10 = "Interfered Completely. Higher scores indicate higher symptom interference. The MDASI-Multiple Myeloma (MM) is the MDASI plus 7 additional items assessing symptoms specific to patients with MM (constipation, muscle weakness, diarrhea, sore mouth/throat, rash, difficulty concentrating and bone aches).

Perceived Stress Scale is a 10-item self-report questionnaire that measures a person's self-reported evaluation of their perception of stressfulness in a situation over the past 1 month of their lives. It assesses a person's feelings and thoughts over a 1-month period. Participants rate each item on a 4-point scale (0 = "never," 1 = "almost never," 2 = "sometimes," 3 = "fairly often," 4 = "often") producing scores ranging from 0-40. Scores are obtained by reversing the scores on items 4,5,7 and 8 like so: 0=1,1=3,2=2,3=1,4=0, and then adding up the scores for each item to obtain a total score. Higher scores indicate greater stress.

Participants will complete the 8-item PROMIS Sleep Disturbance Short Form (PROMIS-SD) during assessment periods to assess the pure domain of sleep disturbances among adults ages 18 and older. Participants rate each item on a 5-point scale (1 = "never," 2 = "rarely," 3 = "sometimes," 4 = "often," 5 = "always"), producing scores ranging from 8-40. Raw scores for the 8 items are summed for a global score; higher scores indicate greater severity of sleep disturbance.

Participants, 18 years and older, will complete the 13-item PROMIS Fatigue Short Form items which asses a range of self-reported symptoms of fatigue from mild feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that decreases one's ability to execute daily activities and function normally in family or social roles. On the form, Participant Fatigue is divided by the impact of fatigue on physical, mental, and social activities. All items assess fatigue over the past 7 days. Participants will rate each item on a 5-point scale (1= "Not at all", 2= "A little bit", 3= "Somewhat", 4= "Quite a bit", 5= "Very much"). Scores will be summed to produce a total or raw score ranging from 8. (lowest score) to 40, with a higher score indicating more frequent fatigue. If all questions were responded to, a scoring table will be used to generate the T-score.

The CEL will be performed in hospital sites over a 2-month period.

The comparator lighting will be performed identical to Arm 1, at specified lower levels of lighting.

The Ambient Light Multiple Myeloma Study

About this trial

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