Clinical trial NCT01700816: Prevention of Delirium After Bone Marrow Transplantation
Official title: Usefulness of Bright Light Therapy in the Prevention of Delirium in Patients Undergoing Hematopoietic Stem Cell Transplant (HSCT)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Delirium
Keywords: Delirium
Hematopoietic stem cell transplantation
Bone marrow transplantation
Bright Light Therapy
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2012-10-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 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

Primary outcomes:
measure: Number of Participants Who Developed Delirium Based on Meeting Criteria on the Delirium Rating Scale and/or Memorial Delirium Assessment Scale
timeFrame: From hospital admission until the date of first documented delirium, assessed up to 28 days post-transplant
Secondary outcomes:
measure: Severity of Delirium Episodes: Memorial Delirium Assessment Scale (MDAS)
timeFrame: From first documented episode of delirium until discharge from the hospital, assessed up to 28 days post-transplant
measure: Average Dose of Antipsychotic Medications Required to Manage Delirium
timeFrame: From admission to hospital to discharge, an expected average of 28 days post-transplant
measure: Hospital Length of Stay
timeFrame: From admission to hospital to discharge, an expected average of 28 days post-transplant
measure: Sodium (Na), Potassium (K), Chloride (Cl), and Carbon Dioxide (CO2)
timeFrame: From admission to hospital to discharge, an expected average of 28 days post-transplant
measure: Serum Creatinine and Blood Urea Nitrogen (BUN)
timeFrame: From admission to hospital to discharge, an expected average of 28 days post-transplant
measure: Red Blood Cells (RBC)
timeFrame: From admission to hospital to discharge, an expected average of 28 days post-transplant
measure: White Blood Cells (WBC)
timeFrame: From admission to hospital to discharge, an expected average of 28 days post-transplant
measure: Hemoglobin (HGB)
timeFrame: From admission to hospital to discharge, an expected average of 28 days post-transplant
measure: Hematocrit (HCT)
timeFrame: From admission to hospital to discharge, an expected average of 28 days post-transplant
measure: Platelet Count
timeFrame: From admission to hospital to discharge, an expected average of 28 days post-transplant
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Carlos Fernandez-Robles, MD
role: PRINCIPAL_INVESTIGATOR
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