Sleep Therapies for Cancer-Related Sleep Disorders

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 0

68 Participants Needed

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.

Research Team

Sriram Yennu

Principal Investigator

M.D. Anderson Cancer Center

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.

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

Treatment Details

Interventions

• Cognitive Behavioral Therapy
• Methylphenidate Hydrochloride
• Multimodal Therapy
• Phototherapy
• Therapeutic Melatonin

Trial Overview The 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

Group I: Arm VIII (placebo, melatonin, sham light intervention, CBT) Experimental Treatment 5 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 Treatment 5 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 Treatment 4 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 Treatment 5 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 Treatment 5 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 Treatment 5 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 Treatment 4 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 Treatment 5 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 for the following indications:

Approved in European Union as Cognitive Behavioral Therapy for:

• Anxiety disorders
• Depressive disorders
• Eating disorders
• Post-traumatic stress disorder (PTSD)
• Obsessive-compulsive disorder (OCD)

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

Approved in Canada as Cognitive Behavioral Therapy for:

• Anxiety disorders
• Depressive disorders
• Eating disorders
• Post-traumatic stress disorder (PTSD)
• Obsessive-compulsive disorder (OCD)

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+