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New combo therapy aims to beat Cancer-Related insomnia

NCT ID NCT01628029

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.