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Methylphenidate and a Nursing Telephone Intervention for Fatigue

NCT00424099 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 197

Last updated 2023-06-01

Study results available
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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.

Conditions

Interventions

DRUG

Methylphenidate

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.

BEHAVIORAL

Nursing Telephone Intervention

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

DRUG

Placebo

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

BEHAVIORAL

Non NTI

Non NTI are calls from research staff 3 times weekly.

Sponsors & Collaborators

  • National Institute of Nursing Research (NINR)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Eduardo Bruera, MD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-09
Primary Completion
2021-11-22
Completion
2021-11-22
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00424099 on ClinicalTrials.gov