Multimodal Therapy for Sleep Disturbances

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 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: July 18, 2014
Last verified: July 2014
  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 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, Caregiver, 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: Baseline to 15 days ] [ Designated as safety issue: No ]
    Change in Pittsburgh Sleep Quality Index (PSQI) score from baseline to Day 15, end of treatment. PSQI is a 19-item questionnaire that is an effective instrument in measuring the quality and patterns of sleep. It differentiates "poor" from "good" sleep by measuring seven areas: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction over the last month. Each area is rated from 0-3 with the higher score reflecting more severe sleep complaints. The PSQI global score ranges from 0 to 21, with a score of 5 or greater indicating significant sleep disturbance. Response defined in this study using a reduction in PSQI global score at day 15 assessments of 3 as compared to baseline.


Estimated Enrollment: 64
Study Start Date: January 2014
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Litebook + Melatonin + Methylphenidate + CBT
Light therapy over 30 minutes for 14 days. Melatonin 20 mg orally at bedtime and Methylphenidate 5 mg orally twice daily for 15 days. Counseling sessions on Days 8 and 15. Well-being questionnaires completed Days 1, 3, 8, 15, and 29, with Study Diaries completed daily.
Device: Litebook
Either light therapy or placebo light over 30 minutes within 2 hours of waking for 14 days.
Drug: Melatonin
20 mg by mouth at bed time.
Drug: Methylphenidate
5 mg by mouth twice daily.
Other Names:
  • Methylphenidate Hydrochloride
  • Ritalin
  • Concerta
Behavioral: Counseling Sessions
Counseling session with a counselor lasting about 30 minutes, either in person or by phone on Days 8 and 15 only.
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.
Experimental: Placebo Litebook + Placebo drugs + CBT
Placebo light over 30 minutes for 14 days. One placebo capsule orally twice during day, and one at bedtime for 15 days. Counseling session on Days 8 and 15. Well-being questionnaires completed Days 1, 3, 8, 15, and 29, with Study Diaries completed daily.
Device: Litebook
Either light therapy or placebo light over 30 minutes within 2 hours of waking for 14 days.
Drug: Placebo
One placebo capsule orally twice a day before 3 PM, and/or one placebo capsule at bedtime.
Other Name: Sugar pill
Behavioral: Counseling Sessions
Counseling session with a counselor lasting about 30 minutes, either in person or by phone on Days 8 and 15 only.
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.
Experimental: Placebo Litebook + Melatonin + Methylphenidate + CBT
Placebo light over 30 minutes for 14 days. Melatonin 20 mg orally at bed time, and Methylphenidate 5 mg by mouth twice daily for 15 days. Counseling session on Days 8 and 15. Well-being questionnaires completed Days 1, 3, 8, 15, and 29, with Study Diaries completed daily.
Device: Litebook
Either light therapy or placebo light over 30 minutes within 2 hours of waking for 14 days.
Drug: Melatonin
20 mg by mouth at bed time.
Drug: Methylphenidate
5 mg by mouth twice daily.
Other Names:
  • Methylphenidate Hydrochloride
  • Ritalin
  • Concerta
Behavioral: Counseling Sessions
Counseling session with a counselor lasting about 30 minutes, either in person or by phone on Days 8 and 15 only.
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.
Experimental: Litebook + Placebo + Methylphenidate + CBT
Light therapy over 30 minutes for 14 days. Methylphenidate 5 mg by mouth twice daily and one placebo capsule at bedtime for 15 days. Counseling session on Days 8 and 15. Well-being questionnaires completed Days 1, 3, 8, 15, and 29, with Study Diaries completed daily.
Device: Litebook
Either light therapy or placebo light over 30 minutes within 2 hours of waking for 14 days.
Drug: Methylphenidate
5 mg by mouth twice daily.
Other Names:
  • Methylphenidate Hydrochloride
  • Ritalin
  • Concerta
Drug: Placebo
One placebo capsule orally twice a day before 3 PM, and/or one placebo capsule at bedtime.
Other Name: Sugar pill
Behavioral: Counseling Sessions
Counseling session with a counselor lasting about 30 minutes, either in person or by phone on Days 8 and 15 only.
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.
Experimental: Litebook + Melatonin + Placebo + CBT
Light therapy over 30 minutes for 14 days. Melatonin 20 mg orally at bed time, and one placebo capsule orally twice daily for 15 days. Counseling session on Days 8 and 15. Well-being questionnaires completed Days 1, 3, 8, 15, and 29, with Study Diaries completed daily.
Device: Litebook
Either light therapy or placebo light over 30 minutes within 2 hours of waking for 14 days.
Drug: Melatonin
20 mg by mouth at bed time.
Drug: Placebo
One placebo capsule orally twice a day before 3 PM, and/or one placebo capsule at bedtime.
Other Name: Sugar pill
Behavioral: Counseling Sessions
Counseling session with a counselor lasting about 30 minutes, either in person or by phone on Days 8 and 15 only.
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.
Experimental: Litebook + Placebo Drugs + CBT
Light therapy over 30 minutes for 14 days. One placebo capsule orally twice daily, and one at bedtime for 15 days. Counseling session on Days 8 and 15. Well-being questionnaires completed Days 1, 3, 8, 15, and 29, with Study Diaries completed daily.
Device: Litebook
Either light therapy or placebo light over 30 minutes within 2 hours of waking for 14 days.
Drug: Placebo
One placebo capsule orally twice a day before 3 PM, and/or one placebo capsule at bedtime.
Other Name: Sugar pill
Behavioral: Counseling Sessions
Counseling session with a counselor lasting about 30 minutes, either in person or by phone on Days 8 and 15 only.
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.
Experimental: Placebo Litebook + Placebo + Methylphenidate + CBT
Placebo light over 30 minutes for 14 days. One placebo capsule at bedtime, and Methylphenidate 5 mg orally twice daily for 15 days. Counseling session on Days 8 and 15. Well-being questionnaires completed Days 1, 3, 8, 15, and 29, with Study Diaries completed daily.
Device: Litebook
Either light therapy or placebo light over 30 minutes within 2 hours of waking for 14 days.
Drug: Methylphenidate
5 mg by mouth twice daily.
Other Names:
  • Methylphenidate Hydrochloride
  • Ritalin
  • Concerta
Drug: Placebo
One placebo capsule orally twice a day before 3 PM, and/or one placebo capsule at bedtime.
Other Name: Sugar pill
Behavioral: Counseling Sessions
Counseling session with a counselor lasting about 30 minutes, either in person or by phone on Days 8 and 15 only.
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.
Experimental: Placebo Litebook + Melatonin + Placebo + CBT
Placebo light over 30 minutes for 14 days. Melatonin 20 mg orally at bed time, and one placebo capsule orally twice daily for 15 days. Counseling session on Days 8 and 15. Well-being questionnaires completed Days 1, 3, 8, 15, and 29, with Study Diaries completed daily.
Device: Litebook
Either light therapy or placebo light over 30 minutes within 2 hours of waking for 14 days.
Drug: Melatonin
20 mg by mouth at bed time.
Drug: Placebo
One placebo capsule orally twice a day before 3 PM, and/or one placebo capsule at bedtime.
Other Name: Sugar pill
Behavioral: Counseling Sessions
Counseling session with a counselor lasting about 30 minutes, either in person or by phone on Days 8 and 15 only.
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.

  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, cancer patients currently on cancer therapy with a positive screening for SD (Screening PSQI score >/= 5).
  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 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 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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 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, NCI-2012-01352
Study First Received: June 22, 2012
Last Updated: July 18, 2014
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:
Dyssomnias
Neoplasms
Parasomnias
Sleep Disorders
Mental Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Melatonin
Methylphenidate
Antioxidants
Central Nervous System Agents
Central Nervous System Depressants
Central Nervous System Stimulants
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014