D-MPH in the Treatment of Fatigue and Neurobehavioral Function Related to Chemotherapy in Adult Cancer Patients
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|ClinicalTrials.gov Identifier: NCT00047476|
Recruitment Status : Completed
First Posted : October 9, 2002
Last Update Posted : June 24, 2005
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|Condition or disease||Intervention/treatment||Phase|
|Fatigue Neoplasms||Drug: dexmethylphenidate(d-mph)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Official 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|
|Study Start Date :||June 2002|
|Study Completion Date :||March 2004|
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|Ages Eligible for Study:||18 Years to 70 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00047476
|Other Study ID Numbers:||
|First Posted:||October 9, 2002 Key Record Dates|
|Last Update Posted:||June 24, 2005|
|Last Verified:||May 2004|
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