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Multimodal Therapy for the Treatment of Sleep Disturbance in Patients With Advanced Cancer

Phase 2
18 Years
Not Enrolling
Advanced Cancers

Thank you

Trial Information

Multimodal Therapy for the Treatment of Sleep Disturbance in Patients With Advanced Cancer

If you are found eligible and agree to take part, you will meet with a counselor. You will
be asked to discuss your thoughts and feelings on different topics related to your
well-being. The counseling session will last about 45 minutes.

You will be given a watch to wear that records your body movements. This is called an
actigraph. You should wear it all times, except in the shower or bathtub. On Day 15 (+/- 3
days), you will return the watch to the study staff and they will download information from

Study Groups:

You will be randomly assigned (as in the roll of dice) to 1 of 8 study groups.

You will have an equal chance of being assigned to any group. You will have a 50% chance of
receiving the placebo capsule or light therapy placebo.

The skills learned during counseling will be different for each study group. The study
staff will talk to you about your assigned skills.

Neither you nor the medical study staff will know which group you are in. If needed for
your safety, the medical staff will be able to find out which group you are in.


All patients will use a device called a Litebook to receive either the light therapy or the
placebo light for 30 minutes within 2 hours of waking up. You will do this for 14 days.
The placebo light is not designed to have any effect on your sleep.

The Litebook is about the size of a deck of cards. To use the Litebook, you will place it
on a table within 2 feet of you while you are sitting down. You do not need to look
directly into the Litebook and you can do usual activities such as eating or reading while
you are using it. The study staff will teach you how to use the Litebook.

Study Diaries:

You will complete the following diaries at the end of each day of the 14-day study period:

- The light exposure diary about how much light you were exposed to using the Litebook.

- The pill diary about your medication/placebo.

It should take about 5 minutes each day to make entries in the study diaries. You will
return the diaries to the study staff at the end of the study period.

Study Drug/Placebo Administration:

You will take the one methylphenidate/placebo capsule by mouth with a cup (8 ounces) of
water, 2 times each day. You must take both doses before 3 PM and wait at least 2 hours
between doses. We will instruct patients that methylphenidate may be taken without regards
to meals and stored at room temperature. Patients will also receive a copy of the
FDA-approved Medication Guide specific to methylphenidate.

You will also take the one Melatonin/placebo capsule by mouth with a cup (8 ounces) of water
at bedtime.

Study Visits:

For all study visits/calls, you will be asked about any drugs you may be taking or any side
effects you may be having. At home during the study, you will continue practicing skills
from the counseling sessions and use the Litebook.

If not done at Screening, at Baseline (first visit):

- Your medical history will be recorded.

- You will have a physical exam, including measurement of your vital signs.

- You will be asked to complete the same 6 questionnaires from Screening. This should
take about 30 minutes total.

On Days 3, 8, and 15 (+/- 3 days) you will return to the clinic or be called on the phone if
you are unable to return to the clinic in person:

- You will be asked to complete a questionnaire that asks about any symptoms and/or side
effects you may be having. This should take about 10 minutes.

- You will be asked to complete 4 questionnaires. Each questionnaire should take about 5
minutes to complete, for a total of 25 minutes. The questionnaires ask about:

- Your emotional and physical well being

- Your level of fatigue

- Any anxiety and/or depression you may be having

- Any symptoms you may be having

- On Days 8 and 15 only, you will have a counselling session with a counselor either in
person or by phone. This should last about 30 minutes.

Length of Study Participation:

You will take the study drug/placebo for up to 15 days (+/- 1 week) and will have a follow
up visit at Day 29 (+/- 1 week). You will no longer be able to take the study drug/placebo
if the disease gets worse, if intolerable side effects occur, if you are unable to follow
study directions, or if you cannot complete enough of the treatment combination as planned.

Your participation on the study will be over after you have completed the follow-up visit.

Follow-Up Visit:

At Day 29 (+/- 1 week) after your last dose of study drug/placebo, you will return to the
clinic for a follow-up visit.

- You will be asked about any side effects you may have had.

- You will have a physical exam, including measurement of your vital signs.

- Your performance status will be recorded.

- If not done in the past 15 days, blood (about 1 tablespoon) will be drawn for routine

- You will be asked to complete 4 questionnaires. Each questionnaire should take about 5
minutes to complete, for a total of 25 minutes. The questionnaires ask about:

- Your emotional and physical well being

- Your level of fatigue

- Any anxiety and/or depression you may be having

- Any symptoms you may be having

At Day 45 (+/- 5 days) or 30 days (+/- 5 days) you will receive a follow up telephone call
or return for a follow up visit to assess for side effects of the treatments.

This is an investigational study. Melatonin is an investigational drug. Melatonin is
considered a food/nutritional supplement.

The use of light therapy in patients with difficulty sleeping is investigational. It is
currently being used for research purposes only.

The combination of methylphenidate, melatonin, light therapy, and counselling for patients
with difficulty sleeping is considered investigational.

Up to 64 patients will take part in this study. All will be enrolled at MD Anderson.

Inclusion Criteria:

1. Patients who are 18 years or older, with advanced cancer (defined as metastatic and
locally advanced) and a positive screening for SD (>/=4/10 on a 0-10 scale).

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 at least one cycle of chemotherapy or targeted therapy,
or > 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 1 month) 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.

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 anticoagulants, anticonvulsants (phenobarbital,
diphenylhydantoin, primidone), phenylbutazone, clonidine, and/or tricyclic drugs
(imipramine, clomipramine, or desipramine).

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 (light
exposure diary - screening).

15. Patients with a diagnosis of obesity hypoventilation syndrome.

16. Negative 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Change in Pittsburgh Sleep Quality Index (PSQI) Score

Outcome Description:

Primary outcome is change in Pittsburgh Sleep Quality Index (PSQI) score. Estimates of treatment effects and combinations of treatment effects obtained by using standard linear regression techniques in which change in PSQI values are regressed on indicator variables that represent treatment combinations that received 3 main effects for the primary treatments, 3 two-way interaction terms for each combination of two treatments, and 1 three-way interaction effects, which will be included in linear regression model.

Outcome Time Frame:

15 days

Safety Issue:


Principal Investigator

Sriram Yennu, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

July 2013

Completion Date:

Related Keywords:

  • Advanced Cancers
  • Advanced Cancers
  • Metastatic
  • Locally advanced
  • Sleep disturbance
  • Sleep problems
  • Litebook
  • Melatonin
  • Methylphenidate
  • Methylphenidate hydrochloride
  • Ritalin
  • Concerta
  • Placebo
  • Supportive counseling
  • Questionnaires
  • Study Diaries
  • Sleep Disorders
  • Dyssomnias
  • Parasomnias
  • Neoplasms



UT MD Anderson Cancer Center Houston, Texas  77030