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

Celgene

Status and phase: Completed; Phase 2

Conditions: Neoplasms; Fatigue

Treatments: Drug: dexmethylphenidate(d-mph)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00047476

d-MPH-COG-002

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind