Trial Summary
What is the purpose of this trial?
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.
Eligibility Criteria
This trial is for cancer patients experiencing sleep disturbances, on stable pain control, and undergoing cancer therapy. They must have a certain level of physical functioning (Zubrod <= 2), controlled symptoms of pain and depression, normal organ function tests, and not be on excluded medications or have specific conditions like blindness or major psychiatric disorders.Inclusion Criteria
Your blood creatinine level is less than or equal to 2.0 mg/dL.
I have been on a stable dose of certain medications like dexamethasone or zolpidem for 2 weeks.
My pain is either nonexistent or under control with stable medication for the past week.
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Exclusion Criteria
I have fast heartbeats and high blood pressure that my doctor finds concerning.
Unable to speak and understand English
Unable to complete the baseline assessment forms or to understand the recommendations for participation in the study
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Treatment Details
Interventions
- Cognitive Behavioral Therapy (Behavioural Intervention)
- Methylphenidate Hydrochloride (Other)
- Multimodal Therapy (Behavioural Intervention)
- Phototherapy (Procedure)
- Therapeutic Melatonin (Other)
Trial OverviewThe study is testing whether cognitive behavioral therapy combined with methylphenidate hydrochloride (a stimulant), therapeutic melatonin (a sleep aid), and light therapy can improve sleep quality, reduce fatigue, and enhance overall well-being in cancer patients with sleep issues.
Participant Groups
8Treatment groups
Experimental Treatment
Group I: Arm VIII (placebo, melatonin, sham light intervention, CBT)Experimental Treatment5 Interventions
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.
Group II: Arm VII (methylphenidate, placebo, sham light therapy, CBT)Experimental Treatment5 Interventions
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.
Group III: Arm VI (placebo, placebo, light therapy, CBT)Experimental Treatment4 Interventions
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.
Group IV: Arm V (placebo, melatonin, light therapy, CBT)Experimental Treatment5 Interventions
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.
Group V: Arm IV (methylphenidate, placebo, light therapy, CBT)Experimental Treatment5 Interventions
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.
Group VI: Arm III (methylphenidate, melatonin, sham light therapy, CBT)Experimental Treatment5 Interventions
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.
Group VII: Arm II (placebo, placebo, sham light therapy, CBT)Experimental Treatment4 Interventions
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.
Group VIII: Arm I (methylphenidate, melatonin, light therapy, CBT)Experimental Treatment5 Interventions
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.
Cognitive Behavioral Therapy is already approved in European Union, United States, Canada, Australia for the following indications:
πͺπΊ Approved in European Union as Cognitive Behavioral Therapy for:
- Anxiety disorders
- Depressive disorders
- Eating disorders
- Post-traumatic stress disorder (PTSD)
- Obsessive-compulsive disorder (OCD)
πΊπΈ Approved in United States as Cognitive Behavioral Therapy for:
- Anxiety disorders
- Depressive disorders
- Eating disorders
- Post-traumatic stress disorder (PTSD)
- Obsessive-compulsive disorder (OCD)
- Substance use disorders
π¨π¦ Approved in Canada as Cognitive Behavioral Therapy for:
- Anxiety disorders
- Depressive disorders
- Eating disorders
- Post-traumatic stress disorder (PTSD)
- Obsessive-compulsive disorder (OCD)
π¦πΊ Approved in Australia as Cognitive Behavioral Therapy for:
- Anxiety disorders
- Depressive disorders
- Eating disorders
- Post-traumatic stress disorder (PTSD)
- Obsessive-compulsive disorder (OCD)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
M D Anderson Cancer CenterHouston, TX
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Who Is Running the Clinical Trial?
M.D. Anderson Cancer CenterLead Sponsor
National Cancer Institute (NCI)Collaborator