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Prevention of Delirium After Bone Marrow Transplantation

This study has been terminated.
(Low incidence of delirium.)
Sponsor:
Collaborator:
American Cancer Society, Inc.
Information provided by (Responsible Party):
Carlos Fernandez-Robles, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01700816
First received: October 1, 2012
Last updated: May 26, 2017
Last verified: May 2017
  Purpose
The purpose of this study is to find out if using bright light sessions during bone marrow transplant can prevent people from developing confusion also known as delirium.

Condition Intervention
Delirium Device: Bright light therapy Device: Sham light

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Outcomes Assessor
Primary Purpose: Prevention
Official Title: Usefulness of Bright Light Therapy in the Prevention of Delirium in Patients Undergoing Hematopoietic Stem Cell Transplant (HSCT)

Resource links provided by NLM:


Further study details as provided by Carlos Fernandez-Robles, Massachusetts General Hospital:

Primary Outcome Measures:
  • Number of Participants Who Developed Delirium Based on Meeting Criteria on the Delirium Rating Scale and/or Memorial Delirium Assessment Scale [ Time Frame: From hospital admission until the date of first documented delirium, assessed up to 28 days post-transplant ]
    Monday, Wednesday, and Friday assessments will begin after beginning light therapy and include the Delirium Rating Scale-Revised-98 (DRS-98)and Memorial Delirium Assessment Scale (MDAS)


Secondary Outcome Measures:
  • Severity of Delirium Episodes: Memorial Delirium Assessment Scale (MDAS) [ Time Frame: From first documented episode of delirium until discharge from the hospital, assessed up to 28 days post-transplant ]

    Monday, Wednesday, and Friday assessments of the Memorial Delirium Assessment Scale (MDAS); Patients will receive assessments after beginning light therapy until day 28 post-transplant or discharge, whichever comes first.

    10 item scale Items are rated on a four-point scale from 0 (none) to 3 (severe) depending on the level of impairment, rendering a maximum possible score of 30.

    A score of 13 has been recommended as a cut-off for establishing the diagnosis of delirium


  • Average Dose of Antipsychotic Medications Required to Manage Delirium [ Time Frame: From admission to hospital to discharge, an expected average of 28 days post-transplant ]
  • Hospital Length of Stay [ Time Frame: From admission to hospital to discharge, an expected average of 28 days post-transplant ]
  • Sodium (Na), Potassium (K), Chloride (Cl), and Carbon Dioxide (CO2) [ Time Frame: From admission to hospital to discharge, an expected average of 28 days post-transplant ]
    Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT (Hematopoietic Stem Cell Transplantation).

  • Serum Creatinine and Blood Urea Nitrogen (BUN) [ Time Frame: From admission to hospital to discharge, an expected average of 28 days post-transplant ]
    Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.

  • Red Blood Cells (RBC) [ Time Frame: From admission to hospital to discharge, an expected average of 28 days post-transplant ]
    Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.

  • White Blood Cells (WBC) [ Time Frame: From admission to hospital to discharge, an expected average of 28 days post-transplant ]
    Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.

  • Hemoglobin (HGB) [ Time Frame: From admission to hospital to discharge, an expected average of 28 days post-transplant ]
    Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.

  • Hematocrit (HCT) [ Time Frame: From admission to hospital to discharge, an expected average of 28 days post-transplant ]
    Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.

  • Platelet Count [ Time Frame: From admission to hospital to discharge, an expected average of 28 days post-transplant ]
    Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.


Enrollment: 40
Study Start Date: October 2012
Study Completion Date: October 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bright light therapy
2500 Lux gaze directed every morning from 8 am until 8:30 am
Device: Bright light therapy
The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am.
Other Name: DL930 Day-Light Classic by Uplift Technologies Inc.
Placebo Comparator: Sham light
<1000 Lux gaze directed every morning from 8 am until 8:30 am
Device: Sham light
The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am.
Other Name: DL930 Day-Light Classic Uplift Tecnologies placebo box

Detailed Description:

This is a pilot, double blind randomized study conducted in patients scheduled to undergo bone marrow transplant at the Massachusetts General Hospital. The goal of this study is to look at the usefulness of bright light therapy in the prevention of delirium in a population at high risk for developing this condition.

Delirium can develop in up to half of the people that undergo bone marrow transplant. Symptoms include changes in level of alertness, confusion, and temporary problems with memory and attention. In severe cases, it can be accompanied by agitation, paranoia(overly suspicious), and hallucinations(seeing or hearing things that are not really there).

Bright light uses no medication and is often used to treat seasonal affective depression and multiple sleep disorders. The light boxes are portable and are placed in front of individuals for about 30 minutes every day.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 or older
  • Male or female
  • Patients scheduled to undergo HSCT
  • English speaking

Exclusion Criteria:

  • Previous history of bipolar affective disorder
  • On-going delirium
  • History of substance abuse/dependence within 6 months prior to HSCT
  • History of invasive melanoma. Patients with a history of basal cell carcinoma, melanoma in situ, or squamous cell carcinoma are permitted to enroll if the lesion(s) have been excised with negative margins
  • History of medical/dermatological conditions that make skin especially sensitive to light,such as systemic lupus erythematosus (SLE) and/or porphyria
  • Eye condition that makes eyes vulnerable to light damage
  • Concomitant use of medications that increase sensitivity to sunlight, such as the herbal supplement St. John's Wort
  • Established primary insomnia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01700816

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
American Cancer Society, Inc.
Investigators
Principal Investigator: Carlos Fernandez-Robles, MD Massachusetts General Hospital
  More Information

Publications:
Reitan RM. Validity of the Trail Making test as an indicator of organic brain damage. Perceptual and Motor Skills 8: 271-276, 1958.
Derogatis LR, Savitz, KL. The SCL-90-R and the Brief Symptom Inventory (BSI) in Primary Care In: M.E.Maruish, ed. Handbook of psychological assessment in primary care settings 236: 297,334, 2000. Mahwah, NJ: Lawrence Erlbaum Associates.

Responsible Party: Carlos Fernandez-Robles, Principal Investigator, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01700816     History of Changes
Other Study ID Numbers: 2010P002801
Study First Received: October 1, 2012
Results First Received: October 27, 2016
Last Updated: May 26, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Carlos Fernandez-Robles, Massachusetts General Hospital:
Delirium
Hematopoietic stem cell transplantation
Bone marrow transplantation
Bright Light Therapy

Additional relevant MeSH terms:
Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on June 29, 2017