Sleep Therapies for Cancer-Related Sleep Disorders
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the effectiveness of different sleep therapies for cancer patients with sleep problems. Participants will try various combinations of treatments, including cognitive behavioral therapy (a type of talk therapy), light therapy (also known as phototherapy), and medications like methylphenidate (a stimulant) and melatonin, to determine which combination best improves sleep and overall quality of life. It is open to cancer patients currently undergoing therapy who struggle with sleep disturbances and have their pain under control.
As a Phase 2 trial, this research measures how well the treatment works in an initial, smaller group of people, offering participants the opportunity to contribute to advancements in sleep therapy for cancer patients.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you can participate if you are on stable doses of certain medications like dexamethasone, mirtazapine, zolpidem, benzodiazepines, and phenothiazines. However, you cannot participate if you are currently taking or have recently taken medications like methylphenidate, certain antidepressants, or anticonvulsants.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that cognitive behavioral therapy (CBT) is safe and well-tolerated by cancer survivors, with most patients experiencing no side effects. Methylphenidate hydrochloride, another component of the trial, is also considered safe. Studies indicate it is generally well-tolerated, with only a few patients discontinuing treatment due to side effects.
Therapeutic melatonin, used in the trial, is generally safe, though information on long-term use is limited. Higher doses have shown no harm in healthy individuals. Phototherapy, or light therapy, is considered safe and easy to use, with few side effects, making it a low-risk option for improving sleep quality.
Overall, these treatments are usually well-tolerated by patients. However, discussing any personal concerns with healthcare providers is important.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for cancer-related sleep disorders because they combine cognitive behavioral therapy (CBT) with other innovative approaches like light therapy, melatonin, and methylphenidate. Unlike standard treatments that might rely solely on medication or simple sleep hygiene practices, this trial explores a multimodal approach. The combination of therapies aims to target sleep issues from multiple angles: CBT helps change negative thought patterns, light therapy can reset the body's internal clock, melatonin regulates the sleep-wake cycle, and methylphenidate could combat fatigue. By integrating these methods, researchers hope to provide a more comprehensive and effective treatment option that addresses various aspects of sleep disorders in cancer patients.
What evidence suggests that this trial's treatments could be effective for cancer-related sleep disorders?
Research has shown that cognitive behavioral therapy (CBT), one of the treatments in this trial, helps address sleep problems in cancer patients. Studies indicate that CBT significantly improves insomnia and reduces tiredness. Melatonin, another treatment option in this trial, is a hormone that regulates sleep and has been found to enhance sleep quality and lessen cancer-related fatigue. Light therapy, also tested in this trial, uses bright light to reset sleep patterns and has proven effective in improving sleep quality and reducing insomnia symptoms in cancer patients. Methylphenidate, another treatment under study, is sometimes used for tiredness but has not consistently outperformed a placebo for cancer-related fatigue. Overall, CBT, melatonin, and light therapy have strong evidence supporting their effectiveness in improving sleep issues in cancer patients.35678
Who Is on the Research Team?
Sriram Yennu
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo cognitive behavioral therapy, receive methylphenidate hydrochloride, therapeutic melatonin, and light therapy or their placebos for 15 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cognitive Behavioral Therapy
- Methylphenidate Hydrochloride
- Multimodal Therapy
- Phototherapy
- Therapeutic Melatonin
Cognitive Behavioral Therapy is already approved in European Union, United States, Canada for the following indications:
- Anxiety disorders
- Depressive disorders
- Eating disorders
- Post-traumatic stress disorder (PTSD)
- Obsessive-compulsive disorder (OCD)
- Anxiety disorders
- Depressive disorders
- Eating disorders
- Post-traumatic stress disorder (PTSD)
- Obsessive-compulsive disorder (OCD)
- Substance use disorders
- Anxiety disorders
- Depressive disorders
- Eating disorders
- Post-traumatic stress disorder (PTSD)
- Obsessive-compulsive disorder (OCD)
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator