Recruiting
Phase 2
Phase 3

Combination Therapy

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT05474846

Conditions

Sleep

Fatigue

Anxiety

Cancer

Depression

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Melatonin

Placebo for Melatonin

Melatonin

Methylphenidate

Study Details

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

Study ID

NCT05474846

Start date

Nov 21, 2022

Status verified date

Nov, 2025

Completion date

Feb 28, 2027

Anticipated

Primary completion date

Feb 28, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

188 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Combination Therapy (BLT+MT+MP with CBT)

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.

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

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.

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

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.

experimental: Methylphenidate (CLT + placebo MT + MP with CBT)

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.

Interventions

Melatonin

Given by PO

Placebo for Melatonin

Given by PO

Melatonin

Given by PO

Methylphenidate

Given by PO

Primary outcome measure

  • Pittsburgh Sleep Quality Index (PSQI) questionnaires [ Time Frame: Through the study completion, an average of 1 year. ]

Central Contacts and Locations

Central contacts

Locations

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Nov 6, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2025-11-06.