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

NCT05474846 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2022-0180NCI-2022-06045
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sleep; Fatigue; Anxiety; Cancer; Depression

Outcome Measures

Primary Outcomes (1)

• Pittsburgh Sleep Quality Index (PSQI) questionnaires

  Pittsburgh Sleep Quality Index (PSQI) questionnaire score on a 4-point scale ranging from 0 (not during the 2 weeks) to 3 (3 or more times a week).

  Through the study completion, an average of 1 year.

Study Arms (4)

Combination Therapy (BLT+MT+MP with CBT)

EXPERIMENTAL

Patients receive Melatonin (called MT) PO QD for 6 weeks, Methylphenidate (called MP) PO BID for 6 weeks, Bright Light Therapy (called BLT) for 30 minutes daily for 6 weeks, and Cognitive Behavior Therapy (called CBT) weekly for 6 weeks.

Drug: Melatonin; Other: Placebo for Melatonin; Drug: Methylphenidate

Placebo (CLT+ placebo MT + placebo MP with CBT)

EXPERIMENTAL

Patients receive placebo Melatonin (called placebo MT) PO QD for 6 weeks, placebo Methylphenidate (called placebo MP) PO BID for 6 weeks, Control Light Therapy (called CLT) for 30 minutes daily for 6 weeks and Cognitive Behavior Therapy (called CBT) weekly for 6 weeks.

Drug: Melatonin; Other: Placebo for Melatonin

Bright light and Melatonin (BLT + MT+ placebo MP with CBT)

EXPERIMENTAL

Patients receive Bright Light Therapy (called BLT) for 30 minutes daily for 6 weeks, Melatonin (called MT) PO QD for 6 weeks, placebo Methylphenidate (called placebo MP) PO BID for 6 weeks, and Cognitive Behavior Therapy (called CBT) weekly for 6 weeks.

Other: Placebo for Melatonin; Drug: Methylphenidate

Methylphenidate (CLT + placebo MT + MP with CBT)

EXPERIMENTAL

Patients receive Control Light Therapy (called CLT) for 30 minutes daily for 6 weeks, placebo Melatonin (called placebo MT) PO QD for 6 weeks, Methylphenidate (called MP) PO BID for 6 weeks, and Cognitive Behavior Therapy (called CBT) weekly for 6 weeks.

Drug: Melatonin

Interventions

Placebo for Melatonin OTHER

Given by PO

Also known as: Placebo for Methylphendate Given by PO, Control Light Therapy Sham Therapy, behavioral: Cognitive Behavior Therapy Counseling session

Bright light and Melatonin (BLT + MT+ placebo MP with CBT); Combination Therapy (BLT+MT+MP with CBT); Placebo (CLT+ placebo MT + placebo MP with CBT)

Melatonin DRUG

Given by PO

Also known as: Methylphenidate Given by PO, Behavioral: Bright Light Therapy, Behavioral: Cognitive Behavior Therapy

Combination Therapy (BLT+MT+MP with CBT); Placebo (CLT+ placebo MT + placebo MP with CBT)

Methylphenidate DRUG

Given by PO

Also known as: Placebo for Melatonin Given by PO, Control Light Therapy Sham Therapy, Behavioral: Cognitive Behavior Therapy Counseling session

Bright light and Melatonin (BLT + MT+ placebo MP with CBT); Combination Therapy (BLT+MT+MP with CBT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 (MDAS) (≤ 13/30);
• willing and able to sign a written informed consent;
• 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
• 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.

You may not qualify if:

• 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; and
• 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 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Fatigue; Anxiety Disorders; Neoplasms; Depression

Interventions

Melatonin; Cognitive Behavioral Therapy; Methylphenidate

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Sriram Yennu, MD

  MD Anderson

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sriram Yennu, MD

CONTACT

713-792-6085; syennu@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2022
• First Posted: July 26, 2022
• Study Start: November 21, 2022
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: November 6, 2025

Record last verified: 2025-11

Locations

US (1)