Multimodal Therapy for Sleep Disturbances

This study is not yet open for participant recruitment.
Verified April 2013 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01628029
First received: June 22, 2012
Last updated: April 25, 2013
Last verified: April 2013
  Purpose

The goal of this clinical research study is to learn about the effects of different combinations of melatonin, supportive counseling, light therapy, and methylphenidate/placebo in patients with advanced cancer having sleep problems. The safety of these treatment combinations will also be studied.

Methylphenidate is designed to increase the activity of the central nervous system.

Melatonin is a hormone that is made by the brain and may help in letting your body know when it is time to go to sleep and when it is time to wake up.

A placebo is not a drug. It looks like the study drug but is not designed to treat any symptom, disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.

Light therapy is designed to help people sleep better.

Supportive counseling is designed to help to control symptoms, fatigue, anxiety, depression, pain, and/or sleep disorders.

The use of the therapies to treat sleep disturbance in combination is experimental.


Condition Intervention Phase
Advanced Cancers
Device: Litebook
Drug: Melatonin
Drug: Methylphenidate
Drug: Placebo
Behavioral: Counseling Sessions
Behavioral: Questionnaires
Behavioral: Study Diaries
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Multimodal Therapy for the Treatment of Sleep Disturbance in Patients With Advanced Cancer

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Change in Pittsburgh Sleep Quality Index (PSQI) Score [ Time Frame: 15 days ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 64
Study Start Date: July 2013
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Litebook + Melatonin + Methylphenidate + CBT
Patients receive light therapy for 30 minutes within 2 hours of waking up for 14 days. Melatonin 20 mg by mouth bed time. Methylphenidate 5 mg by mouth twice daily. The last dose of the twice a day regimen should be prior to 3pm and the interval between doses should be at least 2 hours. Counseling session with a counselor, either in person or by phone on Days 8 and 15 only. This should last about 30 minutes. Symptom and emotional well-being questionnaires completed on Days 1, 3, 8, 15, and 29. Completion of diaries at the end of each day of the 14-day study period, explaining how much light received from Litebook, and a pill diary about medication/placebo.
Device: Litebook
Patients receive either the light therapy or the placebo light for 30 minutes within 2 hours of waking up for 14 days.
Drug: Melatonin
20 mg by mouth bed time.
Drug: Methylphenidate
5 mg by mouth twice daily. The last dose of the twice a day regimen should be prior to 3pm and the interval between doses should be at least 2 hours.
Other Names:
  • Methylphenidate Hydrochloride
  • Ritalin
  • Concerta
Behavioral: Counseling Sessions
Counseling session with a counselor, either in person or by phone on Days 8 and 15 only. This should last about 30 minutes.
Behavioral: Questionnaires
Symptom and emotional well-being questionnaires completed on Days 1, 3, 8, 15, and 29.
Other Name: Surveys
Behavioral: Study Diaries
Completion of diaries at the end of each day of the 14-day study period, explaining how much light received from Litebook, and a pill diary about medication/placebo.
Experimental: Placebo Litebook + Placebo drugs + CBT
Patients receive placebo light for 30 minutes within 2 hours of waking up for 14 days. One placebo capsule by mouth with a cup (8 ounces) of water, 2 times each day before 3 PM, and/or one placebo capsule with a cup (8 ounces) of water at bedtime. Counseling session with a counselor, either in person or by phone on Days 8 and 15 only. This should last about 30 minutes. Symptom and emotional well-being questionnaires completed on Days 1, 3, 8, 15, and 29. Completion of diaries at the end of each day of the 14-day study period, explaining how much light received from Litebook, and a pill diary about medication/placebo.
Device: Litebook
Patients receive either the light therapy or the placebo light for 30 minutes within 2 hours of waking up for 14 days.
Drug: Placebo
One placebo capsule by mouth with a cup (8 ounces) of water, 2 times each day before 3 PM, and/or one placebo capsule with a cup (8 ounces) of water at bedtime.
Other Name: Sugar pill
Behavioral: Counseling Sessions
Counseling session with a counselor, either in person or by phone on Days 8 and 15 only. This should last about 30 minutes.
Behavioral: Questionnaires
Symptom and emotional well-being questionnaires completed on Days 1, 3, 8, 15, and 29.
Other Name: Surveys
Behavioral: Study Diaries
Completion of diaries at the end of each day of the 14-day study period, explaining how much light received from Litebook, and a pill diary about medication/placebo.
Experimental: Placebo Litebook + Melatonin + Methylphenidate + CBT
Patients receive placebo light for 30 minutes within 2 hours of waking up for 14 days. Melatonin 20 mg by mouth bed time. Methylphenidate 5 mg by mouth twice daily. The last dose of the twice a day regimen should be prior to 3pm and the interval between doses should be at least 2 hours. Counseling session with a counselor, either in person or by phone on Days 8 and 15 only. This should last about 30 minutes. Symptom and emotional well-being questionnaires completed on Days 1, 3, 8, 15, and 29. Completion of diaries at the end of each day of the 14-day study period, explaining how much light received from Litebook, and a pill diary about medication/placebo.
Device: Litebook
Patients receive either the light therapy or the placebo light for 30 minutes within 2 hours of waking up for 14 days.
Drug: Melatonin
20 mg by mouth bed time.
Drug: Methylphenidate
5 mg by mouth twice daily. The last dose of the twice a day regimen should be prior to 3pm and the interval between doses should be at least 2 hours.
Other Names:
  • Methylphenidate Hydrochloride
  • Ritalin
  • Concerta
Behavioral: Counseling Sessions
Counseling session with a counselor, either in person or by phone on Days 8 and 15 only. This should last about 30 minutes.
Behavioral: Questionnaires
Symptom and emotional well-being questionnaires completed on Days 1, 3, 8, 15, and 29.
Other Name: Surveys
Behavioral: Study Diaries
Completion of diaries at the end of each day of the 14-day study period, explaining how much light received from Litebook, and a pill diary about medication/placebo.
Experimental: Litebook + Placebo + Methylphenidate + CBT
Patients receive light therapy for 30 minutes within 2 hours of waking up for 14 days. One placebo capsule by mouth with a cup (8 ounces) of water, 2 times each day before 3 PM, and/or one placebo capsule with a cup (8 ounces) of water at bedtime. Methylphenidate 5 mg by mouth twice daily. The last dose of the twice a day regimen should be prior to 3pm and the interval between doses should be at least 2 hours. Counseling session with a counselor, either in person or by phone on Days 8 and 15 only. This should last about 30 minutes. Symptom and emotional well-being questionnaires completed on Days 1, 3, 8, 15, and 29. Completion of diaries at the end of each day of the 14-day study period, explaining how much light received from Litebook, and a pill diary about medication/placebo.
Device: Litebook
Patients receive either the light therapy or the placebo light for 30 minutes within 2 hours of waking up for 14 days.
Drug: Methylphenidate
5 mg by mouth twice daily. The last dose of the twice a day regimen should be prior to 3pm and the interval between doses should be at least 2 hours.
Other Names:
  • Methylphenidate Hydrochloride
  • Ritalin
  • Concerta
Drug: Placebo
One placebo capsule by mouth with a cup (8 ounces) of water, 2 times each day before 3 PM, and/or one placebo capsule with a cup (8 ounces) of water at bedtime.
Other Name: Sugar pill
Behavioral: Counseling Sessions
Counseling session with a counselor, either in person or by phone on Days 8 and 15 only. This should last about 30 minutes.
Behavioral: Questionnaires
Symptom and emotional well-being questionnaires completed on Days 1, 3, 8, 15, and 29.
Other Name: Surveys
Behavioral: Study Diaries
Completion of diaries at the end of each day of the 14-day study period, explaining how much light received from Litebook, and a pill diary about medication/placebo.
Experimental: Litebook + Melatonin + Placebo + CBT
Patients receive light therapy for 30 minutes within 2 hours of waking up for 14 days. Melatonin 20 mg by mouth bed time.One placebo capsule by mouth with a cup (8 ounces) of water, 2 times each day before 3 PM, and/or one placebo capsule with a cup (8 ounces) of water at bedtime. Counseling session with a counselor, either in person or by phone on Days 8 and 15 only. This should last about 30 minutes. Symptom and emotional well-being questionnaires completed on Days 1, 3, 8, 15, and 29. Completion of diaries at the end of each day of the 14-day study period, explaining how much light received from Litebook, and a pill diary about medication/placebo.
Device: Litebook
Patients receive either the light therapy or the placebo light for 30 minutes within 2 hours of waking up for 14 days.
Drug: Melatonin
20 mg by mouth bed time.
Drug: Placebo
One placebo capsule by mouth with a cup (8 ounces) of water, 2 times each day before 3 PM, and/or one placebo capsule with a cup (8 ounces) of water at bedtime.
Other Name: Sugar pill
Behavioral: Counseling Sessions
Counseling session with a counselor, either in person or by phone on Days 8 and 15 only. This should last about 30 minutes.
Behavioral: Questionnaires
Symptom and emotional well-being questionnaires completed on Days 1, 3, 8, 15, and 29.
Other Name: Surveys
Behavioral: Study Diaries
Completion of diaries at the end of each day of the 14-day study period, explaining how much light received from Litebook, and a pill diary about medication/placebo.
Experimental: Experimental: Litebook + Placebo Drugs + CBT
Patients receive light therapy for 30 minutes within 2 hours of waking up for 14 days. One placebo capsule by mouth with a cup (8 ounces) of water, 2 times each day before 3 PM, and/or one placebo capsule with a cup (8 ounces) of water at bedtime. Counseling session with a counselor, either in person or by phone on Days 8 and 15 only. This should last about 30 minutes. Symptom and emotional well-being questionnaires completed on Days 1, 3, 8, 15, and 29. Completion of diaries at the end of each day of the 14-day study period, explaining how much light received from Litebook, and a pill diary about medication/placebo.
Device: Litebook
Patients receive either the light therapy or the placebo light for 30 minutes within 2 hours of waking up for 14 days.
Drug: Placebo
One placebo capsule by mouth with a cup (8 ounces) of water, 2 times each day before 3 PM, and/or one placebo capsule with a cup (8 ounces) of water at bedtime.
Other Name: Sugar pill
Behavioral: Counseling Sessions
Counseling session with a counselor, either in person or by phone on Days 8 and 15 only. This should last about 30 minutes.
Behavioral: Questionnaires
Symptom and emotional well-being questionnaires completed on Days 1, 3, 8, 15, and 29.
Other Name: Surveys
Behavioral: Study Diaries
Completion of diaries at the end of each day of the 14-day study period, explaining how much light received from Litebook, and a pill diary about medication/placebo.
Experimental: Placebo Litebook + Placebo + Methylphenidate + CBT
Patients receive placebo light for 30 minutes within 2 hours of waking up for 14 days. One placebo capsule by mouth with a cup (8 ounces) of water, 2 times each day before 3 PM, and/or one placebo capsule with a cup (8 ounces) of water at bedtime. Methylphenidate 5 mg by mouth twice daily. The last dose of the twice a day regimen should be prior to 3pm and the interval between doses should be at least 2 hours. Counseling session with a counselor, either in person or by phone on Days 8 and 15 only. This should last about 30 minutes. Symptom and emotional well-being questionnaires completed on Days 1, 3, 8, 15, and 29. Completion of diaries at the end of each day of the 14-day study period, explaining how much light received from Litebook, and a pill diary about medication/placebo.
Device: Litebook
Patients receive either the light therapy or the placebo light for 30 minutes within 2 hours of waking up for 14 days.
Drug: Methylphenidate
5 mg by mouth twice daily. The last dose of the twice a day regimen should be prior to 3pm and the interval between doses should be at least 2 hours.
Other Names:
  • Methylphenidate Hydrochloride
  • Ritalin
  • Concerta
Drug: Placebo
One placebo capsule by mouth with a cup (8 ounces) of water, 2 times each day before 3 PM, and/or one placebo capsule with a cup (8 ounces) of water at bedtime.
Other Name: Sugar pill
Behavioral: Counseling Sessions
Counseling session with a counselor, either in person or by phone on Days 8 and 15 only. This should last about 30 minutes.
Behavioral: Questionnaires
Symptom and emotional well-being questionnaires completed on Days 1, 3, 8, 15, and 29.
Other Name: Surveys
Behavioral: Study Diaries
Completion of diaries at the end of each day of the 14-day study period, explaining how much light received from Litebook, and a pill diary about medication/placebo.
Experimental: Placebo Litebook + Melatonin + Placebo + CBT
Patients receive placebo light for 30 minutes within 2 hours of waking up for 14 days. Melatonin 20 mg by mouth bed time. One placebo capsule by mouth with a cup (8 ounces) of water, 2 times each day before 3 PM, and/or one placebo capsule with a cup (8 ounces) of water at bedtime.Counseling session with a counselor, either in person or by phone on Days 8 and 15 only. This should last about 30 minutes. Symptom and emotional well-being questionnaires completed on Days 1, 3, 8, 15, and 29. Completion of diaries at the end of each day of the 14-day study period, explaining how much light received from Litebook, and a pill diary about medication/placebo.
Device: Litebook
Patients receive either the light therapy or the placebo light for 30 minutes within 2 hours of waking up for 14 days.
Drug: Melatonin
20 mg by mouth bed time.
Drug: Placebo
One placebo capsule by mouth with a cup (8 ounces) of water, 2 times each day before 3 PM, and/or one placebo capsule with a cup (8 ounces) of water at bedtime.
Other Name: Sugar pill
Behavioral: Counseling Sessions
Counseling session with a counselor, either in person or by phone on Days 8 and 15 only. This should last about 30 minutes.
Behavioral: Questionnaires
Symptom and emotional well-being questionnaires completed on Days 1, 3, 8, 15, and 29.
Other Name: Surveys
Behavioral: Study Diaries
Completion of diaries at the end of each day of the 14-day study period, explaining how much light received from Litebook, and a pill diary about medication/placebo.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 </= 2.
  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 </= 13.
  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 </= 2.0 mg/dL, Total bilirubin </=1.5 mg/dL, and AST (SGOT) and ALT (SGPT) </=2 x ULN or </= 5 x ULN if 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01628029

Contacts
Contact: Sriram Yennu, MD 713-792-6085

Locations
United States, Texas
UT MD Anderson Cancer Center Not yet recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Sriram Yennu, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01628029     History of Changes
Other Study ID Numbers: 2012-0120
Study First Received: June 22, 2012
Last Updated: April 25, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Advanced Cancers
Metastatic
Locally advanced
Sleep disturbance
Sleep problems
Litebook
Melatonin
Methylphenidate
Methylphenidate hydrochloride
Ritalin
Concerta
Placebo
Supportive counseling
Questionnaires
Study Diaries

Additional relevant MeSH terms:
Sleep Disorders
Dyssomnias
Parasomnias
Neoplasms
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Melatonin
Methylphenidate
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Central Nervous System Stimulants

ClinicalTrials.gov processed this record on May 21, 2013