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

Status: active

This phase II/III trial studies how well cognitive behavior therapy (CBT) and combination therapy works in treating sleep disturbance in patients with cancer that has spread to other places in the body (advanced). Cognitive behavior therapy is a counseling technique found to improve sleep disturbance. Light therapy is designed to use light to improve the sleeping/waking cycle or pattern in order to help people sleep better. Methylphenidate is a medication designed to increase activity of the central nervous system. Melatonin is a hormone that is made in your brain. Changes in melatonin level help the body know when it is time to go to sleep and when it is time to wake up. Giving combination therapy may help improve sleep and other related symptoms such as fatigue, anxiety, and depression in cancer patients.

Inclusion Criteria

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
Ability to communicate in English
Cognitively competent to respond appropriately to questions, as measured by the Memorial Delirium Assessment Scale (=< 13/30)
Willing and able to sign a written informed consent
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
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)
Age 18 years or older
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

Active use of systemic anti-inflammatory prescription medications including steroids; unless used during or prior to cancer treatment as a prophylaxis (i.e., nausea)
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
Hospital Anxiety and Depression (HADS) score ≥ 21, or use of antidepressants, unless the patient is receiving a stable dose for at least 1 month
Use of hypnosedative drugs or stimulants; unless on stable doses of hypnosedative drugs or stimulants for at least 1 month
Use of monoamine oxidase inhibitors (MOI), tricyclic anti-depressants and anticoagulants
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
Other medical reason that increases patient risk as determined by principal investigator (PI)
For patients participating in the MRI data collection component of the study, we will exclude the participants who meet the following criteria: * 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 * Claustrophobia
Pregnancy as documented in the medical record

PRIMARY OBJECTIVE:

I. To compare the effects of the combination therapy arm with the placebo arm on sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI) at the end of 6 weeks.

SECONDARY OBJECTIVES:

I. To compare the effects of the combination therapy arm with the placebo arm on sleep quality (PSQI) at 3- and 6-months post-intervention.

II. To compare the effects of the remaining active therapy arms with the placebo and combination arms on PSQI at all post-intervention assessments.

III. To compare the effects of the active therapy arm and the placebo arm for sleep-wake cycle disturbance (Actigraphy - sleep onset latency, wake after sleep onset, total sleep time, sleep efficiency, and mean daytime activity).

IV. To determine whether the addition of methylphenidate (MP) to bright light therapy (BLT) + melatonin (MT) synergistically maintains sleep quality as measured by change from baseline PSQI.

EXPLORATORY OBJECTIVES:

I. To explore the effects of the active therapy arm on psychological symptoms (Hospital Anxiety and Depression Scale), fatigue (Functional Assessment of Chronic Illness Therapy – Fatigue), sleep and related symptoms (Patient-Reported Outcomes Measurement Information System [PROMIS]-Sleep), inflammation (C-reactive protein), resting-state cognition (Amsterdam resting-state questionnaire, [ARSQ]) and quality of life (Functional Assessment of Cancer Therapy – General) and how they vary over time.

II. To explore changes in brain function and structure (using functional, structural and diffusion-weighted magnetic resonance imaging [MRI]) and changes in resting-state cognition (ARSQ) and sleep symptoms following (a) combination therapy arm (i.e., CBT + BLT + MP + MT); (b) CBT + BLT + MT + placebo (MP); (c) CBT + MP + placebo (control light + MT); and (d) CBT + placebo (control light + MT + MP).

OUTLINE: Patients are randomized to 1 of 4 arms.

ARM I: Patients undergo 6 CBT sessions over 45 minutes and light therapy over 30 minutes for 6 weeks. Patients also receive melatonin orally (PO) daily and methylphenidate PO twice daily (BID) for 6 weeks. Patients also undergo MRI at baseline and on study.

ARM II: Patients undergo 6 CBT sessions over 45 minutes and placebo light therapy over 30 minutes for 6 weeks. Patients also receive placebo melatonin PO daily and placebo methylphenidate PO BID for 6 weeks. . Patients also undergo MRI at baseline and on study.

ARM III: Patients undergo 6 CBT sessions over 45 minutes and light therapy over 30 minutes for 6 weeks. Patients also receive melatonin PO daily and placebo methylphenidate PO BID for 6 weeks. Patients also undergo MRI at baseline and on study.

ARM IV: Patients undergo 6 CBT sessions over 45 minutes and placebo light therapy over 30 minutes for 6 weeks. Patients also receive placebo melatonin PO daily and methylphenidate PO BID for 6 weeks. Patients also undergo MRI at baseline and on study.

After completion of study treatment, patients are followed up at 3 and 6 months.

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

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Exclusion Criteria

United States

Texas

Houston

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

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