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Usefulness of Bright Light Therapy in the Prevention of Delirium in Patients Undergoing Hematopoietic Stem Cell Transplant (HSCT)


N/A
18 Years
90 Years
Open (Enrolling)
Both
Delirium

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Trial Information

Usefulness of Bright Light Therapy in the Prevention of Delirium in Patients Undergoing Hematopoietic Stem Cell Transplant (HSCT)


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

Incidence of delirium (Time to the development of delirium based on meeting criteria on the Delirium Rating Scale and/or Memorial Delirium Assessment Scale)

Outcome Description:

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)

Outcome Time Frame:

From hospital admission until the date of first documented delirium, assessed up to 28 days post-transplant

Safety Issue:

No

Principal Investigator

Carlos Fernandez-Robles, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital

Authority:

United States: Institutional Review Board

Study ID:

2010P002801

NCT ID:

NCT01700816

Start Date:

October 2012

Completion Date:

April 2014

Related Keywords:

  • Delirium
  • Delirium
  • Hematopoietic stem cell transplantation
  • Bone marrow transplantation
  • Bright Light Therapy
  • Delirium

Name

Location

Massachusetts General Hospital Boston, Massachusetts  02114-2617