Prevention of Delirium After Bone Marrow Transplantation

• ClinicalTrials.gov Identifier: NCT01700816
• Recruitment Status: Terminated
• First Posted: October 4, 2012
• Results First Posted: June 28, 2017
• Last Update Posted: June 28, 2017
• Sponsor: Massachusetts General Hospital
• Collaborator: American Cancer Society, Inc.
• Information provided by (Responsible Party): Carlos Fernandez-Robles, Massachusetts General Hospital

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Delirium	Device: Bright light therapy; Device: Sham light	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (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)
• Study Start Date: October 2012
• Actual Primary Completion Date: September 2013
• Actual Study Completion Date: October 2013

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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 :

1. 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

2. 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 ]
3. Hospital Length of Stay [ Time Frame: From admission to hospital to discharge, an expected average of 28 days post-transplant ]
4. 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).
5. 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.
6. 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.
7. 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.
8. 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.
9. 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.
10. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 90 Years (Adult, Older Adult)
• 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

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:

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Fricchione GL, Nejad SH, Esses JA, Cummings TJ Jr, Querques J, Cassem NH, Murray GB. Postoperative delirium. Am J Psychiatry. 2008 Jul;165(7):803-12. doi: 10.1176/appi.ajp.2008.08020181.

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• Responsible Party: Carlos Fernandez-Robles, Principal Investigator, MD, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT01700816
• Other Study ID Numbers: 2010P002801
• First Posted: October 4, 2012
• Results First Posted: June 28, 2017
• Last Update Posted: June 28, 2017
• Last Verified: May 2017

Individual Participant Data (IPD) Sharing Statement:

• 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; Neurocognitive Disorders; Mental Disorders