CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 68 enrolled
Drug / intervention
Methylphenidate Hydrochloride +6 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01628029
NCT01628029Phase 2Active

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

M.D. Anderson Cancer Center·interventional·Posted Jun 26, 2012·Updated May 22, 2026

In Brief

A Phase 2 clinical trial evaluating Counseling, Methylphenidate Hydrochloride, and 5 other interventions for Hematopoietic and Lymphoid Cell Neoplasm and 2 related conditions. Active but no longer recruiting, targeting 68 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2Active
20132014201520162017201820192020202120222023202420252026202720282029
First PostedJun 26, 2012
Enrollment StartJan 15, 2014
Primary CompletionDec 22, 2025
Study CompletionDec 31, 2028
TodayJul 1, 2026
Enrollment to primary: 11.9 yearsPosted 14.0 years ago

Interventions

Counselingother

Undergo CBT

Methylphenidate Hydrochloridedrug

Given PO

Phototherapyprocedure

Undergo light therapy

Placebo Administrationother

Given PO

Quality-of-Life Assessmentother

Ancillary studies

Sham Interventionprocedure

Undergo sham light therapy

Therapeutic Melatonindrug

Given PO