Combination therapy to improve sleep in advanced cancer patients

Combination Therapy for Treatment of Sleep Disturbance in Patients With Advanced Cancer

This study is testing if a mix of therapy and medications can help improve sleep and reduce fatigue, anxiety, and depression in people with advanced cancer.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 188 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: M.D. Anderson Cancer Center (Academic / other)
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT05474846 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of Cognitive Behavior Therapy (CBT) combined with Bright Light Therapy (BLT), methylphenidate, and melatonin in improving sleep quality and related symptoms such as fatigue, anxiety, and depression in patients with advanced cancer. Participants will be randomly assigned to receive either the combination therapies or placebos, with sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI) at various intervals. The study will also explore the impact of these therapies on sleep-wake cycle disturbances through actigraphy measurements. The primary endpoint is to determine if the combination therapy leads to better sleep quality compared to placebo after six weeks.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with advanced cancer experiencing poor sleep quality for at least two weeks.

Not a fit: Patients with uncontrolled pain or those who do not meet the cognitive and communication criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly enhance sleep quality and overall well-being for patients suffering from advanced cancer.

How similar studies have performed: Other studies have shown promising results with similar combination therapies for sleep disturbances in cancer patients, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

1. presence of poor sleep quality, defined as Pittsburgh Sleep Quality Index (PSQI) total score ≥ 5, with patients describing poor sleep as being present for a minimum of 2 weeks;
2. ability to communicate in English;
3. cognitively competent to respond appropriately to questions, as measured by the Memorial Delirium Assessment Scale (MDAS) (≤ 13/30);
4. willing and able to sign a written informed consent;
5. life expectancy of ≥ 1 year as assessed by the oncologist or the principal investigator (SY) using the "surprise question," "Would I be surprised if this patient died in the next 12 months?"; and
6. no pain or stable pain (defined as pain ≤ 4 on Edmonton Symptom Assessment Scale (ESAS) or under control and on stable doses of opioids for 1 month).
7. Age 18 years or older
8. be willing to complete in-person or telemedicine follow-up visits with research staff, and able to complete CBT intervention either in person or virtually within Texas.

Exclusion Criteria:

1. active use of systemic anti-inflammatory prescription medications including steroids; unless used during or prior to cancer treatment as a prophylaxis (i.e., nausea);
2. known history of psychiatric illness (e.g., schizophrenia, bipolar disorder, major depressive disorder), sleep disorder (e.g., obstructive sleep apnea, narcolepsy, periodic limb movement disorder), obesity hypoventilation syndrome, glaucoma, congenital blindness, self-reported acquired blindness, significant cataracts or retinal disease; and night shift workers.
3. Hospital Anxiety and Depression (HADS) score ≥21, or use of antidepressants, unless the patient is receiving a stable dose for at least 1 month;
4. use of hypnosedative drugs or stimulants; unless on stable doses of hypnosedative drugs or stimulants for at least 1 month;
5. use of monoamine oxidase inhibitors (MOI), tricyclic anti-depressants and anticoagulants; and
6. patients who have bright sunlight exposure for consecutive 30 minutes or more daily in the past month, or prior exposure to BLT, or prior use of MT, MP, or CBT.
7. other medical reason that increases patient risk as determined by PI.
8. For patients participating in the MRI data collection component of the study, we will exclude the participants who meet the following criteria:

   1. . Any metallic objects in the body. Metal plates, certain types of dental braces, cardiac pacemakers, ext., that are sensitive to electromagnetic fields contraindicate MRI scans
   2. . Claustrophobia
9. Pregnancy as documented in the medical record

Where this trial is running

Houston, Texas

• MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Sriram Yennu, MD — MD Anderson
• Study coordinator: Sriram Yennu, MD

Conditions Sleep; Fatigue; Anxiety; Cancer; Depression