CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 197 enrolled
Drug / intervention
Methylphenidate +3 moredrug
Likely dose
Methylphenidate 5 mgfrom 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/NCT00424099
NCT00424099Phase 3Completed
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A Randomized Controlled Trial of Methylphenidate and a Nursing Telephone Intervention (NTI) for Fatigue in Advanced Cancer Patients

M.D. Anderson Cancer Center·interventional·Posted Jan 18, 2007·Updated Jun 1, 2023

In Brief

A Phase 3 clinical trial evaluating Methylphenidate, Nursing Telephone Intervention, and 2 other interventions for Advanced Cancer and Fatigue. Completed, enrolled 197 participants across 2 sites.

Detailed Summary

The goal of this clinical research study is to learn if methylphenidate (Ritalin) can help to control fatigue caused by cancer. Its effect on other symptoms such as drowsiness, depression, sleeplessness, physical activity, and anxiety will also be studied. Another goal of this study is to learn if receiving a phone call by a nurse improves fatigue in patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Cancer, Fatigue
CountriesUnited States
CollaboratorsNational Institute of Nursing Research (NINR)

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 18, 2007
Enrollment StartJan 9, 2007
Primary CompletionNov 22, 2021
TodayJul 2, 2026
Enrollment to primary: 14.9 yearsPosted 19.5 years ago

Interventions

Methylphenidatedrug

5 mg (one capsule) orally every two hours as needed up to a maximum of 20 mg per day for a period of 14 days.

Nursing Telephone Interventionbehavioral

Call from study nurse 3 times weekly to ask about side effects and other symptoms.

Placebodrug

One capsule, orally every two hours as needed up to a maximum of 4 capsules per day for a period of 14 days.

Non NTIbehavioral

Non NTI are calls from research staff 3 times weekly.