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Sleep Therapies for Cancer-Related Sleep Disorders

Phase 2

Waitlist Available

Led By Sriram Yennu

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with no pain and with stable pain (defined as pain under control and on stable doses of opioids for 1 week) are eligible

Patients should have a Zubrod =< 2

Must not have

Currently receiving anticonvulsants (phenobarbital, diphenylhydantoin, primidone), phenylbutazone, clonidine, and/or tricyclic drugs (imipramine, clomipramine, or desipramine)

Patients with a history of retinal disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to day 29

Summary

This trial is studying how well two types of therapy work to treat sleep issues in people with cancer.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include reactions to the stimulant such as increased heart rate or blood pressure, digestive changes due to melatonin use, eye strain from light therapy, and general discomfort that sometimes accompanies counseling sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My pain is either nonexistent or under control with stable medication for the past week.

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I am mostly able to carry out my daily activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking medication for seizures, pain, blood pressure, or depression.

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I have a history of eye problems related to the retina.

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I have been diagnosed with obesity hypoventilation syndrome.

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I have been diagnosed with major depression, bipolar disorder, OCD, or schizophrenia.

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I need medication for depression or blood pressure.

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I have glaucoma.

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I have been diagnosed with sleep apnea or narcolepsy through a sleep study.

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I am blind from birth or have become blind over time, and I cannot see any light.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to day 29

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to day 29

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to day 29 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Pittsburgh Sleep Quality Index (PSQI) score

Secondary study objectives

Change in Edmonton Symptom Assessment System (ESAS) scores

Change in Functional Assessment of Chronic Illness Therapy (FACIT)-F scores

Change in Hospital Anxiety Depression Scale (HADS) scores

+2 more

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Phototherapy

2021

Completed Phase 4

~750

Methylphenidate Hydrochloride

2008

Completed Phase 4

~1610