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therapeutic melatonin

radiation therapy

Lawrence B. Berk, MD, PhD

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as melatonin may make tumor cells more sensitive to radiation therapy and may protect normal cells from the side effects of radiation therapy.

PURPOSE: Randomized phase II trial to determine the effectiveness of combining melatonin with radiation therapy in treating patients who have brain metastases.

OBJECTIVES:

* Determine the effect of melatonin, used as radiosensitization/radioprotection, on overall survival and clinical deterioration in patients with brain metastases who are undergoing radiotherapy.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to planned chemotherapy after whole brain irradiation (yes vs no). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients undergo whole brain irradiation once daily 5 days a week for 2 weeks. Patients receive oral melatonin once daily every morning.
* Arm II: Patients undergo whole brain irradiation as in arm I. Patients receive oral melatonin once daily every evening.

All patients continue on melatonin for 6 months in the absence of disease progression or unacceptable toxicity.

Patients are followed at months 6 and 12 from start of radiotherapy and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 128 patients (64 per treatment arm) will be accrued for this study within 5 months.

Melatonin and Radiation Therapy in Treating Patients With Brain Metastases

A Randomized Phase II Study of A.M. and P.M. Melatonin for Brain Metastasis in RPA Class II Patients

National Cancer Institute (NCI)

Radiation Therapy Oncology Group

Behaviors and Mental Disorders

Dyssomnias

Parasomnias

Sleep Wake Disorders

Neurologic Manifestations

Mental Disorders

Psychotic Disorders

Central Nervous System Stimulants

Cardiotonic Agents

Methylphenidate

Dopamine

Dopamine Uptake Inhibitors

Dopamine Agents

Neurotransmitter Agents

Patients undergo CBT comprising 3 30-minute counseling sessions between baseline and day 14. Patients also receive methylphenidate hydrochloride PO BID and therapeutic melatonin PO QD, and undergo light therapy over 30 minutes for 15 days.

Patients undergo CBT as in Arm I. Patients also receive methylphenidate placebo PO BID and melatonin placebo PO QD, and undergo sham light therapy over 30 minutes for 15 days.

Patients undergo CBT as in Arm I. Patients also receive methylphenidate hydrochloride PO BID and therapeutic melatonin PO QD, and undergo sham light therapy over 30 minutes for 15 days.

Patients undergo CBT as in Arm I. Patients also receive methylphenidate hydrochloride PO BID and melatonin placebo PO QD, and undergo light therapy over 30 minutes for 15 days.

Patients undergo CBT as in Arm I. Patients also receive methylphenidate placebo PO BID and therapeutic melatonin PO QD, and undergo light therapy over 30 minutes for 15 days.

Patients undergo CBT as in Arm I. Patients also receive methylphenidate placebo PO BID and melatonin placebo PO QD, and undergo light therapy over 30 minutes for 15 days.

Patients undergo CBT as in Arm I. Patients also receive methylphenidate hydrochloride PO BID and melatonin placebo PO QD, and undergo sham light therapy over 30 minutes for 15 days.

Patients undergo CBT as in Arm I. Patients also receive methylphenidate placebo PO BID and therapeutic melatonin PO QD, and undergo sham light therapy over 30 minutes for 15 days.

Counseling

Methylphenidate Hydrochloride

Phototherapy

Placebo Administration

Quality-of-Life Assessment

Sham Intervention

Therapeutic Melatonin

Sriram Yennu

This randomized phase II trial studies how well cognitive behavioral therapy and multimodal therapy works in treating sleep disturbance in patients with cancer. Cognitive behavioral therapy may help reduce sleep disturbances, fatigue, and insomnia as well as improve the well-being and quality of life of patients with cancer when given together with methylphenidate hydrochloride, therapeutic melatonin, and light therapy.

PRIMARY OBJECTIVE:

I. To obtain preliminary estimates of the effects of cognitive behavioral therapy (CBT) and various treatments (light therapy, melatonin, methylphenidate \[methylphenidate hydrochloride\]) and combinations of treatments in multimodal therapy (MMT) in reducing sleep disturbance in patients with cancer, as measured by change in Pittsburgh Sleep Quality Index (PSQI) scores taken at baseline and on day 15.

SECONDARY OBJECTIVES:

I. To explore the effect of MMT on Insomnia Severity Index, cancer related symptoms (fatigue \[Functional Assessment of Chronic Illness Therapy (FACIT-F) subscale, Edmonton Symptom Assessment System (ESAS)\], anxiety, depression anxiety \[Hospital Anxiety Depression Scale (HADS), ESAS\]), quality of life (Functional Assessment of Cancer Therapy-General \[FACT-G\], ESAS), and physical activity/sleep efficacy (actigraphy), before and after treatment with various sleep disturbance (SD) treatment combinations of MMT.

II. To determine the safety of MMT (type, frequency, and severity of the adverse events).

OUTLINE: Patients are randomized to 1 of 8 treatment arms.

ARM I: Patients undergo CBT comprising 3 30-minute counseling sessions between baseline and day 14. Patients also receive methylphenidate hydrochloride orally (PO) twice daily (BID) and therapeutic melatonin PO once daily (QD), and undergo light therapy over 30 minutes for 15 days.

ARM II: Patients undergo CBT as in Arm I. Patients also receive methylphenidate placebo PO BID and melatonin placebo PO QD, and undergo sham light therapy over 30 minutes for 15 days.

ARM III: Patients undergo CBT as in Arm I. Patients also receive methylphenidate hydrochloride PO BID and therapeutic melatonin PO QD, and undergo sham light therapy over 30 minutes for 15 days.

ARM IV: Patients undergo CBT as in Arm I. Patients also receive methylphenidate hydrochloride PO BID and melatonin placebo PO QD, and undergo light therapy over 30 minutes for 15 days.

ARM V: Patients undergo CBT as in Arm I. Patients also receive methylphenidate placebo PO BID and therapeutic melatonin PO QD, and undergo light therapy over 30 minutes for 15 days.

ARM VI: Patients undergo CBT as in Arm I. Patients also receive methylphenidate placebo PO BID and melatonin placebo PO QD, and undergo light therapy over 30 minutes for 15 days.

ARM VII: Patients undergo CBT as in Arm I. Patients also receive methylphenidate hydrochloride PO BID and melatonin placebo PO QD, and undergo sham light therapy over 30 minutes for 15 days.

ARM VIII: Patients undergo CBT as in Arm I. Patients also receive methylphenidate placebo PO BID and therapeutic melatonin PO QD, and undergo sham light therapy over 30 minutes for 15 days.

Treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up on days 29 and 45.

Cognitive Behavioral Therapy and Multimodal Therapy in Treating Sleep Disturbance in Patients With Cancer

Multimodal Therapy for the Treatment of Sleep Disturbance in Patients With Cancer

Estimates of treatment effects and combinations of treatment effects will be obtained by using standard linear regression techniques in which the change in PSQI values are regressed on indicator variables that represent treatment combinations that received 3 main effects for the primary treatments, 3 two-way interaction terms for each combination of two treatments, and 1 three-way interaction effects, which will be included in the linear regression model.

Exploratory data analyses to examine associations between patients' change in PSQI score and the secondary measure of Insomnia Severity Index. Multivariate regression analyses will also be performed to determine the predictive relationship of this variable on PSQI and change in PSQI scores.

Exploratory data analyses to examine associations between patients' change in PSQI score and the secondary measure of FACIT-F scores. Multivariate regression analyses will also be performed to determine the predictive relationship of this variable on PSQI and change in PSQI scores.

Exploratory data analyses to examine associations between patients' change in PSQI score and the secondary measure of HADS scores. Multivariate regression analyses will also be performed to determine the predictive relationship of this variable on PSQI and change in PSQI scores.

Exploratory data analyses to examine associations between patients' change in PSQI score and the secondary measure of ESAS scores. Multivariate regression analyses will also be performed to determine the predictive relationship of this variable on PSQI and change in PSQI scores.

Differences between participants receiving the MMT or the placebo treatment will be analyzed. This analysis will be based on fitting mixed effect linear models with actigraphy data as the response variables, and treatment intervention, demographic variables, and treatment site as independent variables.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Melatonin and Radiation Therapy in Treating Patients With Brain Metastases	NCT00031967	Metastatic Canc... Radiation Toxic... Unspecified Adu...	therapeutic mel... radiation thera...	0 Years - 120 Years	Radiation Therapy Oncology Group
Melatonin and Radiation Therapy in Treating Patients With Brain Metastases	NCT00031967	Metastatic Canc... Radiation Toxic... Unspecified Adu...	therapeutic mel... radiation thera...	0 Years - 120 Years	Radiation Therapy Oncology Group
Cognitive Behavioral Therapy and Multimodal Therapy in Treating Sleep Disturbance in Patients With Cancer	NCT01628029	Hematopoietic a... Malignant Solid... Sleep Disorder	Counseling Methylphenidate... Phototherapy Placebo Adminis... Quality-of-Life... Sham Interventi... Therapeutic Mel...	18 Years -	M.D. Anderson Cancer Center
Cognitive Behavioral Therapy and Multimodal Therapy in Treating Sleep Disturbance in Patients With Cancer	NCT01628029	Hematopoietic a... Malignant Solid... Sleep Disorder	Counseling Methylphenidate... Phototherapy Placebo Adminis... Quality-of-Life... Sham Interventi... Therapeutic Mel...	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for therapeutic melatonin