Clinical Trial Details
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NCT01628029 : Multimodal Therapy for the Treatment of Sleep Disturbance in Patients With Advanced Cancer
PhasePhase 2
AgesMin: 18 Years Max: N/A
Inclusion Criteria:

1. Patients who are 18 years or older, cancer patients currently on cancer therapy with
a positive screening for SD (Screening PSQI score >/= 5).

2. Patients should have a Zubrod
3. Patients with no pain and with stable pain(defined as pain under control and on
stable doses of opioids for 1 week) are eligible.

4. Memorial delirium assessment scale
5. Controlled pain and depression symptoms, if present (defined as no change in the
Morphine equivalent dose of 30% or change in the dose of antidepressant medication in
the past 2 weeks).

6. All patients who are receiving chemotherapy and/or radiation therapy are eligible for
study if they have completed > 1 week of radiation therapy, and if they have been
approved to go on study by their primary oncologist. The PI/designated research staff
of this study will obtain and document approval from the primary oncologist and
principal investigator of the clinical trial in case the patient is on another
clinical trial as referenced in the patient's study documents.

7. Laboratory test results within these ranges: Serum creatinine bilirubin hepatic metastases are present. ULN= upper limit of normal.

8. Patients on stable doses (defined as same dose for 2 weeks) of dexamethasone,
mirtazapine, zolpidem, benzodiazepines, phenothiazines are allowed to participate in
the study.

Exclusion Criteria:

1. Have a major contraindication to methylphenidate (MP) (e.g., allergy/hypersensitivity
to study medications or their constituents), light therapy (e.g., currently receiving
UVA/UVB therapy), cognitive behavioral therapy (e.g., schizophrenia), or conditions
making adherence difficult as determined by the attending physician.

2. Currently taking MP or have taken it within the previous 10 days.

3. Patients with a diagnosis of polysomnographically confirmed obstructive sleep apnea
or narcolepsy.

4. Regularly used cognitive behavioral therapy in the last 6 weeks for sleep disturbance

5. Unable to complete the baseline assessment forms or to understand the recommendations
for participation in the study.

6. Currently with a diagnosis of major depression, manic depressive disorder,
obsessive-compulsive disorder, or schizophrenia).

7. Need monoamine oxidase inhibitors, tricyclic antidepressants, or clonidine.

8. Have glaucoma.

9. Symptomatic tachycardia and uncontrolled hypertension (determined to be clinically
significant by the PI).

10. Currently receiving anticonvulsants (phenobarbital, diphenylhydantoin, primidone),
phenylbutazone, clonidine, and/or tricyclic drugs (imipramine, clomipramine, or

11. Unable to speak and understand English.

12. Persons with congenital blindness and self-reported acquired blindness (independent
of the cause) with no light perception.

13. Patients with a history of retinal disease.

14. Patients with >2 hours of direct exposure to outdoor natural light per day by
interview with the Study Coordinator.

15. Patients with a diagnosis of obesity hypoventilation syndrome.

16. Positive pregnancy test for women of childbearing potential, as defined by intact
uterus and ovaries, and a history of menses within the last 12 months. Pregnancy test
to be performed no greater than 14 days prior to consent in study. In cases of women
with elevated b-HCG, these candidates will be eligible to participate so long as the
level of b-HCG is not consistent with pregnancy. Women of childbearing potential need
to be on or use contraception, or be abstinent during the study period. Their male
partners must also use contraception (condom) or maintain abstinence. Birth controls
specifications: Women who are able to become pregnant must use birth control during
the study and for 30 days after.

17. Women who are nursing.

18. Patients who have taken Melatonin within the past two weeks.
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