Multimodal Therapy for Sleep Disturbances
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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 |
- 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:
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:
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:
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:
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 |
Inclusion Criteria:
- 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).
- Patients should have a Zubrod </= 2.
- Patients with no pain and with stable pain(defined as pain under control and on stable doses of opioids for 1 week) are eligible.
- Memorial delirium assessment scale </= 13.
- 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).
- 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.
- 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.
- 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:
- 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.
- Currently taking MP or have taken it within the previous 10 days.
- Patients with a diagnosis of polysomnographically confirmed obstructive sleep apnea or narcolepsy.
- Regularly used cognitive behavioral therapy in the last 6 weeks.
- Unable to complete the baseline assessment forms or to understand the recommendations for participation in the study.
- Currently with a diagnosis of major depression, manic depressive disorder, obsessive-compulsive disorder, or schizophrenia).
- Need monoamine oxidase inhibitors, tricyclic antidepressants, or clonidine.
- Have glaucoma.
- Symptomatic tachycardia and uncontrolled hypertension (determined to be clinically significant by the PI).
- Currently receiving anticoagulants, anticonvulsants (phenobarbital, diphenylhydantoin, primidone), phenylbutazone, clonidine, and/or tricyclic drugs (imipramine, clomipramine, or desipramine).
- Unable to speak and understand English.
- Persons with congenital blindness and self-reported acquired blindness (independent of the cause) with no light perception.
- Patients with a history of retinal disease.
- Patients with >2 hours of direct exposure to outdoor natural light per day (light exposure diary - screening).
- Patients with a diagnosis of obesity hypoventilation syndrome.
- 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.
- Women who are nursing.
Contacts and Locations| Contact: Sriram Yennu, MD | 713-792-6085 |
| United States, Texas | |
| UT MD Anderson Cancer Center | Not yet recruiting |
| Houston, Texas, United States, 77030 | |
| 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