Sleep Therapies for Cancer-Related Sleep Disorders

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Methylphenidate, Anticonvulsants, Tricyclics, others

Disqualifiers: Schizophrenia, Obstructive sleep apnea, Narcolepsy, others

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: 5

Duration: 2 weeks

68 Participants Needed

What You Need to Know Before You Apply

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.

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 cognitive behavioral therapy safe for treating sleep disorders in cancer patients?

Cognitive behavioral therapy (CBT) is considered safe and is the standard treatment for insomnia in the general population and cancer patients. It involves non-drug techniques like changing sleep habits and thoughts about sleep, and has been shown to improve sleep and quality of life without significant safety concerns. ^{1 2 3 4 5}

How is the treatment Cognitive Behavioral Therapy different from other treatments for cancer-related sleep disorders?

Cognitive Behavioral Therapy (CBT) is unique because it focuses on changing thoughts and behaviors that affect sleep, rather than using medication. It includes techniques like stimulus control, sleep restriction, and relaxation, which are tailored to individual needs and can improve sleep, mood, and quality of life for cancer patients. ^{1 3 4 5 6}

What data supports the effectiveness of the treatment Cognitive Behavioral Therapy for cancer-related sleep disorders?

Cognitive Behavioral Therapy (CBT) is considered the standard treatment for insomnia in the general population and is likely effective for cancer patients, as it addresses factors that worsen sleep issues. Techniques like stimulus control and sleep restriction have been shown to help improve sleep in cancer patients. ^{1 2 4 5 7}

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

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo cognitive behavioral therapy, receive methylphenidate hydrochloride, therapeutic melatonin, and light therapy or their placebos for 15 days

2 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

Cognitive behavioral therapy (CBT) techniques, such as stimulus control and relaxation, can effectively address sleep issues in cancer patients, who often face unique challenges that worsen their sleep problems.

The article emphasizes the importance of tailoring CBT techniques to individual factors like age, gender, and cancer history to enhance their effectiveness in improving sleep quality for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for Sleep in Cancer Patients: Research, Techniques, and Individual Considerations. Melton, L.[2020]

Cognitive Behavioral Therapy for Insomnia (CBT-I) has been shown to significantly improve sleep quality and psychological outcomes in cancer patients and survivors, based on a review of 12 studies.

CBT-I not only enhances sleep but may also positively affect mood, fatigue, and overall quality of life, and it can be delivered through various methods to reach more patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleeping well with cancer: a systematic review of cognitive behavioral therapy for insomnia in cancer patients. Garland, SN., Johnson, JA., Savard, J., et al.[2022]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Efficacy of a stepped care approach to deliver cognitive-behavioral therapy for insomnia in cancer patients: a noninferiority randomized controlled trial. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for Sleep in Cancer Patients: Research, Techniques, and Individual Considerations. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Efficacy of mind-body therapies for sleep disturbance in patients with early-stage cancer: A systematic review and network meta-analysis. [2023]

4. Scotland pubmed.ncbi.nlm.nih.gov

Mind-body therapies for sleep disturbance among patients with cancer: A systematic review and meta-analysis. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral therapy for insomnia in patients with cancer. [2018]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Sleeping well with cancer: a systematic review of cognitive behavioral therapy for insomnia in cancer patients. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Impaired sleep and rhythms in persons with cancer. [2022]