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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00047476
Enrollment
160
Registered
2002-10-09
Start date
2002-06-30
Completion date
2004-03-31
Last updated
2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fatigue, Neoplasms

Keywords

neurobehavioral function, chemobrain, chemo brain, fatigue, memory loss, exhausted, trouble concentrating

Brief summary

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

Interventions

DRUGdexmethylphenidate(d-mph)

Sponsors

Celgene Corporation
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026