New combo therapy aims to beat Cancer-Related insomnia
NCT ID NCT01628029
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tests whether combining cognitive behavioral therapy, a stimulant (methylphenidate), melatonin, and light therapy can improve sleep in cancer patients. About 68 patients currently on cancer treatment who have sleep problems will participate. The study measures changes in sleep quality and fatigue over time.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Methylphenidate hydrochloride, melatonin, cognitive behavioral therapy, and light therapy
- What this could lead to
- If successful, this could provide a practical, multi-pronged approach to help cancer patients sleep better and feel less fatigued.
- What could go wrong
- This is a small, early-phase trial with only 68 participants, so results may not apply to everyone. The combination of treatments may cause side effects or not work for all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
68 people
The number who actually took part.
- Started
-
Jan 2014
- Expected to finish
-
Dec 2028
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
M D Anderson Cancer Center
Houston, Texas, 77030, United States
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