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Cognitive Behavioral Therapy and Multimodal Therapy in Treating Sleep Disturbance in Patients With Cancer

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ClinicalTrials.gov Identifier: NCT01628029
Recruitment Status : Active, not recruiting
First Posted : June 26, 2012
Last Update Posted : March 16, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
This randomized phase II trial studies how well cognitive behavioral therapy and multimodal therapy works in treating sleep disturbance in patients with cancer. Cognitive behavioral therapy may help reduce sleep disturbances, fatigue, and insomnia as well as improve the well-being and quality of life of patients with cancer when given together with methylphenidate hydrochloride, therapeutic melatonin, and light therapy.

Condition or disease Intervention/treatment Phase
Hematopoietic and Lymphoid Cell Neoplasm Malignant Solid Neoplasm Sleep Disorder Other: Counseling Drug: Methylphenidate Hydrochloride Procedure: Phototherapy Other: Placebo Administration Other: Quality-of-Life Assessment Procedure: Sham Intervention Drug: Therapeutic Melatonin Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Multimodal Therapy for the Treatment of Sleep Disturbance in Patients With Cancer
Actual Study Start Date : January 15, 2014
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021

Arm Intervention/treatment
Experimental: Arm I (methylphenidate, melatonin, light therapy, CBT)
Patients undergo CBT comprising 3 30-minute counseling sessions between baseline and day 14. Patients also receive methylphenidate hydrochloride PO BID and therapeutic melatonin PO QD, and undergo light therapy over 30 minutes for 15 days.
Other: Counseling
Undergo CBT
Other Name: Counseling Intervention

Drug: Methylphenidate Hydrochloride
Given PO
Other Names:
  • Concerta
  • Quillivant XR
  • Ritalin

Procedure: Phototherapy
Undergo light therapy
Other Names:
  • Actinotherapy
  • Bright Light Therapy
  • light therapy

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Drug: Therapeutic Melatonin
Given PO
Other Names:
  • Circadin
  • Melatonin
  • Melaxen

Experimental: Arm II (placebo, placebo, sham light therapy, CBT)
Patients undergo CBT as in Arm I. Patients also receive methylphenidate placebo PO BID and melatonin placebo PO QD, and undergo sham light therapy over 30 minutes for 15 days.
Other: Counseling
Undergo CBT
Other Name: Counseling Intervention

Other: Placebo Administration
Given PO

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Procedure: Sham Intervention
Undergo sham light therapy
Other Name: Sham Comparator

Experimental: Arm III (methylphenidate, melatonin, sham light therapy, CBT)
Patients undergo CBT as in Arm I. Patients also receive methylphenidate hydrochloride PO BID and therapeutic melatonin PO QD, and undergo sham light therapy over 30 minutes for 15 days.
Other: Counseling
Undergo CBT
Other Name: Counseling Intervention

Drug: Methylphenidate Hydrochloride
Given PO
Other Names:
  • Concerta
  • Quillivant XR
  • Ritalin

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Procedure: Sham Intervention
Undergo sham light therapy
Other Name: Sham Comparator

Drug: Therapeutic Melatonin
Given PO
Other Names:
  • Circadin
  • Melatonin
  • Melaxen

Experimental: Arm IV (methylphenidate, placebo, light therapy, CBT)
Patients undergo CBT as in Arm I. Patients also receive methylphenidate hydrochloride PO BID and melatonin placebo PO QD, and undergo light therapy over 30 minutes for 15 days.
Other: Counseling
Undergo CBT
Other Name: Counseling Intervention

Drug: Methylphenidate Hydrochloride
Given PO
Other Names:
  • Concerta
  • Quillivant XR
  • Ritalin

Procedure: Phototherapy
Undergo light therapy
Other Names:
  • Actinotherapy
  • Bright Light Therapy
  • light therapy

Other: Placebo Administration
Given PO

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Experimental: Arm V (placebo, melatonin, light therapy, CBT)
Patients undergo CBT as in Arm I. Patients also receive methylphenidate placebo PO BID and therapeutic melatonin PO QD, and undergo light therapy over 30 minutes for 15 days.
Other: Counseling
Undergo CBT
Other Name: Counseling Intervention

Procedure: Phototherapy
Undergo light therapy
Other Names:
  • Actinotherapy
  • Bright Light Therapy
  • light therapy

Other: Placebo Administration
Given PO

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Drug: Therapeutic Melatonin
Given PO
Other Names:
  • Circadin
  • Melatonin
  • Melaxen

Experimental: Arm VI (placebo, placebo, light therapy, CBT)
Patients undergo CBT as in Arm I. Patients also receive methylphenidate placebo PO BID and melatonin placebo PO QD, and undergo light therapy over 30 minutes for 15 days.
Other: Counseling
Undergo CBT
Other Name: Counseling Intervention

Procedure: Phototherapy
Undergo light therapy
Other Names:
  • Actinotherapy
  • Bright Light Therapy
  • light therapy

Other: Placebo Administration
Given PO

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Experimental: Arm VII (methylphenidate, placebo, sham light therapy, CBT)
Patients undergo CBT as in Arm I. Patients also receive methylphenidate hydrochloride PO BID and melatonin placebo PO QD, and undergo sham light therapy over 30 minutes for 15 days.
Other: Counseling
Undergo CBT
Other Name: Counseling Intervention

Drug: Methylphenidate Hydrochloride
Given PO
Other Names:
  • Concerta
  • Quillivant XR
  • Ritalin

Other: Placebo Administration
Given PO

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Procedure: Sham Intervention
Undergo sham light therapy
Other Name: Sham Comparator

Experimental: Arm VIII (placebo, melatonin, sham light intervention, CBT)
Patients undergo CBT as in Arm I. Patients also receive methylphenidate placebo PO BID and therapeutic melatonin PO QD, and undergo sham light therapy over 30 minutes for 15 days.
Other: Counseling
Undergo CBT
Other Name: Counseling Intervention

Other: Placebo Administration
Given PO

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Procedure: Sham Intervention
Undergo sham light therapy
Other Name: Sham Comparator

Drug: Therapeutic Melatonin
Given PO
Other Names:
  • Circadin
  • Melatonin
  • Melaxen




Primary Outcome Measures :
  1. Change in Pittsburgh Sleep Quality Index (PSQI) score [ Time Frame: Baseline up to day 29 ]
    Estimates of treatment effects and combinations of treatment effects will be obtained by using standard linear regression techniques in which the 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 the linear regression model.


Secondary Outcome Measures :
  1. Change in Insomnia Severity Index scores [ Time Frame: Baseline up to day 29 ]
    Exploratory data analyses to examine associations between patients' change in PSQI score and the secondary measure of Insomnia Severity Index. Multivariate regression analyses will also be performed to determine the predictive relationship of this variable on PSQI and change in PSQI scores.

  2. Change in Functional Assessment of Chronic Illness Therapy (FACIT)-F scores [ Time Frame: Baseline up to day 29 ]
    Exploratory data analyses to examine associations between patients' change in PSQI score and the secondary measure of FACIT-F scores. Multivariate regression analyses will also be performed to determine the predictive relationship of this variable on PSQI and change in PSQI scores.

  3. Change in Hospital Anxiety Depression Scale (HADS) scores [ Time Frame: Baseline up to day 29 ]
    Exploratory data analyses to examine associations between patients' change in PSQI score and the secondary measure of HADS scores. Multivariate regression analyses will also be performed to determine the predictive relationship of this variable on PSQI and change in PSQI scores.

  4. Change in Edmonton Symptom Assessment System (ESAS) scores [ Time Frame: Baseline up to day 29 ]
    Exploratory data analyses to examine associations between patients' change in PSQI score and the secondary measure of ESAS scores. Multivariate regression analyses will also be performed to determine the predictive relationship of this variable on PSQI and change in PSQI scores.

  5. Change in actigraphy data [ Time Frame: Baseline up to day 15 ]
    Differences between participants receiving the MMT or the placebo treatment will be analyzed. This analysis will be based on fitting mixed effect linear models with actigraphy data as the response variables, and treatment intervention, demographic variables, and treatment site as independent variables.

  6. Incidence of adverse events [ Time Frame: Up to 45 days ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cancer patients currently on cancer therapy with a positive screening for SD (screening PSQI score >= 5)
  • 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 > 1 week of radiation therapy, and if they have been approved to go on study by their primary oncologist; the principal investigator (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
  • Serum creatinine =< 2.0 mg/dL
  • Total bilirubin =< 1.5 mg/dL
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2 x upper limit of normal (ULN) or =< 5 x ULN if hepatic metastases are present
  • 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:

  • Have a major contraindication to methylphenidate (MP) (e.g., allergy/hypersensitivity to study medications or their constituents), light therapy (e.g., currently receiving ultraviolet A [UVA]/ultraviolet B [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 for sleep disturbance
  • 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 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 by interview with the Study Coordinator
  • Patients with a diagnosis of obesity hypoventilation syndrome
  • 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 beta (b)-human chorionic gonadotropin (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 control specifications: women who are able to become pregnant must use birth control during the study and for 30 days after
  • Women who are nursing
  • Patients who have taken melatonin within the past two weeks

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01628029


Locations
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United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Sriram Yennu M.D. Anderson Cancer Center
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01628029    
Other Study ID Numbers: 2012-0120
NCI-2012-01352 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2012-0120 ( Other Identifier: M D Anderson Cancer Center )
First Posted: June 26, 2012    Key Record Dates
Last Update Posted: March 16, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Neoplasms
Sleep Wake Disorders
Parasomnias
Dyssomnias
Nervous System Diseases
Neurologic Manifestations
Mental Disorders
Melatonin
Methylphenidate
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Central Nervous System Stimulants
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Agents
Neurotransmitter Agents