D-MPH in the Treatment of Fatigue and Neurobehavioral Function Related to Chemotherapy in Adult Cancer Patients

To evaluate the efficacy of dexmethylphenidate (d-MPH) in the treatment of chemotherapy-related fatigue in adult cancer subjects.

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Key information

Conditions

Fatigue Chemically-Induced Disorders Chemotherapy-Related Cognitive Impairment Cognition Disorders Cognitive Dysfunction Drug-Related Side Effects and Adverse Reactions Memory Disorders Mental Disorders Neoplasms Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cooper Green Hospital, Jefferson Clinic, Birmingham, Alabama, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Diagnosis of cancer, excluding primary or metastatic brain tumors.
Treated with a minimum of four cycles of a cytotoxic chemotherapy, the last chemotherapy treatment must have been completed at least 2 months prior to study entry.
Physical/neurological examination consistent with the absence of a focal neurological deficit
Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test. In addition, sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner).
Subjects must be able to adhere to the protocol requirements.
Subjects must understand and voluntarily sign an informed consent document.
Subjects must be a native English speaker or fluent in English, and have at least an eighth grade education.

Treatment and study plan

dexmethylphenidate(d-mph)

Drug

Sponsors and collaborators

Lead sponsor

Celgene Corporation

Industry

Registry information

Official study title

Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of d-MPH in the Treatment of Fatigue and Neurobehavioral Impairment Related to Chemotherapy in Adult Cancer Patients

Important dates

Study start: 2002
Study completion: 2004
First posted: Oct 9, 2002
Registry last updated: Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed