Prevention of Delirium After Bone Marrow Transplantation
NCT ID: NCT01700816
Last Updated: 2017-06-28
Study Results
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View full resultsBasic Information
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TERMINATED
NA
40 participants
INTERVENTIONAL
2012-10-31
2013-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Bright light therapy
2500 Lux gaze directed every morning from 8 am until 8:30 am
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.
Sham light
\<1000 Lux gaze directed every morning from 8 am until 8:30 am
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male or female
* Patients scheduled to undergo HSCT
* English speaking
Exclusion Criteria
* 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
18 Years
90 Years
ALL
No
Sponsors
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American Cancer Society, Inc.
OTHER
Massachusetts General Hospital
OTHER
Responsible Party
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Carlos Fernandez-Robles
Principal Investigator, MD
Principal Investigators
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Carlos Fernandez-Robles, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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References
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Kirshner HS. Delirium: a focused review. Curr Neurol Neurosci Rep. 2007 Nov;7(6):479-82. doi: 10.1007/s11910-007-0074-7.
Minden SL, Carbone LA, Barsky A, Borus JF, Fife A, Fricchione GL, Orav EJ. Predictors and outcomes of delirium. Gen Hosp Psychiatry. 2005 May-Jun;27(3):209-14. doi: 10.1016/j.genhosppsych.2004.12.004.
Inouye SK, Schlesinger MJ, Lydon TJ. Delirium: a symptom of how hospital care is failing older persons and a window to improve quality of hospital care. Am J Med. 1999 May;106(5):565-73. doi: 10.1016/s0002-9343(99)00070-4.
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. No abstract available.
Hshieh TT, Fong TG, Marcantonio ER, Inouye SK. Cholinergic deficiency hypothesis in delirium: a synthesis of current evidence. J Gerontol A Biol Sci Med Sci. 2008 Jul;63(7):764-72. doi: 10.1093/gerona/63.7.764.
Kalisvaart KJ, de Jonghe JF, Bogaards MJ, Vreeswijk R, Egberts TC, Burger BJ, Eikelenboom P, van Gool WA. Haloperidol prophylaxis for elderly hip-surgery patients at risk for delirium: a randomized placebo-controlled study. J Am Geriatr Soc. 2005 Oct;53(10):1658-66. doi: 10.1111/j.1532-5415.2005.53503.x.
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Liptzin B, Laki A, Garb JL, Fingeroth R, Krushell R. Donepezil in the prevention and treatment of post-surgical delirium. Am J Geriatr Psychiatry. 2005 Dec;13(12):1100-6. doi: 10.1176/appi.ajgp.13.12.1100.
Sampson EL, Raven PR, Ndhlovu PN, Vallance A, Garlick N, Watts J, Blanchard MR, Bruce A, Blizard R, Ritchie CW. A randomized, double-blind, placebo-controlled trial of donepezil hydrochloride (Aricept) for reducing the incidence of postoperative delirium after elective total hip replacement. Int J Geriatr Psychiatry. 2007 Apr;22(4):343-9. doi: 10.1002/gps.1679.
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Inouye SK, Bogardus ST Jr, Charpentier PA, Leo-Summers L, Acampora D, Holford TR, Cooney LM Jr. A multicomponent intervention to prevent delirium in hospitalized older patients. N Engl J Med. 1999 Mar 4;340(9):669-76. doi: 10.1056/NEJM199903043400901.
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Shigeta H, Yasui A, Nimura Y, Machida N, Kageyama M, Miura M, Menjo M, Ikeda K. Postoperative delirium and melatonin levels in elderly patients. Am J Surg. 2001 Nov;182(5):449-54. doi: 10.1016/s0002-9610(01)00761-9.
McIntyre IM, Norman TR, Burrows GD, Armstrong SM. Human melatonin suppression by light is intensity dependent. J Pineal Res. 1989;6(2):149-56. doi: 10.1111/j.1600-079x.1989.tb00412.x.
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Beglinger LJ, Duff K, Van Der Heiden S, Parrott K, Langbehn D, Gingrich R. Incidence of delirium and associated mortality in hematopoietic stem cell transplantation patients. Biol Blood Marrow Transplant. 2006 Sep;12(9):928-35. doi: 10.1016/j.bbmt.2006.05.009.
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Trzepacz PT, Mittal D, Torres R, Kanary K, Norton J, Jimerson N. Validation of the Delirium Rating Scale-revised-98: comparison with the delirium rating scale and the cognitive test for delirium. J Neuropsychiatry Clin Neurosci. 2001 Spring;13(2):229-42. doi: 10.1176/jnp.13.2.229.
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Other Identifiers
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2010P002801
Identifier Type: -
Identifier Source: org_study_id
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