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

• Status: Not yet recruiting
• Trial end date: 2027-02-28
• Target enrollment: 0
• Participant gender: All

Summary

To learn if Cognitive Behavior Therapy (called CBT), combined with either Bright Light Therapy (called BLT), methylphenidate, and/or melatonin, can help improve sleep and other related symptoms such as fatigue, anxiety, and depression in cancer patients. This is an investigational study. In this study, BLT, Methylphenidate and Melatonin will be compared to their placebos.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Treatments: Melatonin; Methylphenidate

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 (≤ 13/30);

4. willing and able to sign a written informed consent;

5. life expectancy of ≥ 1 year as assessed by the oncologist 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).

Exclusion Criteria:

1. active use of systemic anti-inflammatory prescription medications;

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 ≥ 13, or use of antidepressants, unless the patient is receiving a stable dose for at least 3 months;

4. use of hypnosedative drugs or stimulants; and

5. 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.